León Research, following the recommendations of each Government and the Competent Health Authorities of each country, wants to convey to its workers, clients and suppliers the latest modifications to the organizational measures agreed by the Direction and the contingency committee, as well as those applied to guarantee safety and health of its workers, and the continuity of the activities it performs.

The Project Managers will continue informing all the clients involved about the measures to follow in the management of clinical trials during this special situation. We will continue to confirm with client if these measures are already being addressed at the CRO/Sponsor level and if we can collaborate with our contribution by offering each required activity that is contemplated in the UE and local guides, such as conducting the risk assessment, the contingency plan and timely regulatory notifications.

The set of measures described below will be periodically modified according to the most updated recommendations of the Authorities of each country.

General Measures June 1st, 2020

Operational measures

We will follow the guidelines issued by the Competent Regulatory Authorities for the management of clinical trials during COVID-19. These guides from both the EMA and CA of each country are periodically updated and distributed to all the parties involved where we have activity.

National Competent Authorities have begun to search for time options related to remote monitoring, remote access to medical records, and conditions therefor, provided that methods that restrict access to the records of trial trial participants can be used, in line with the principles of necessity and proportionality.

We are in continuous contact with the agencies to resolve doubts and questions raised for remote monitoring.

León Research will maintain the activity through teleworking during the period considered, regardless of the evolution of the different phases of each locality/Country, for the benefit of the health of the workers and the continuity of the business.

The return to the respective offices will be based on the global evolution of the situation generated by the pandemic, the circumstances of the company, and will always be carried out progressively by the workers.

Continue to promote teleworking in monitoring activities as much as possible to change the current monitoring model towards a remote assistance model for sites and investigators.

Given the progress of the current situation, the monitoring visits are resumed in the differents sites, always following the security measures and the specific guidelines provided from each site.

New protocols to resume work activities in the safest way and agreed by the company and workers:

  • By identifying and evaluating personnel especially sensitive to SARS-COV-2 to define whether additional measures are necessary to adapt the job position.
  • Document with the preventive measures for the personnel in the own work centers, and for the displacement of personnel to other center due to their activity. Document prepared by the Occupational Risk Prevention service according to the government’s recommendations and that agreed by the company.
  • Provide individual protection equipment for workers, who will receive them before displacement, and when they go to the workplace itself.
  • Know the preventive measures of each site to visit.
  • Provide a safe-conduct for the justification of business trips between provinces/localities.
  • León Research’s travel policy prevails on the use of public transport instead of using a private car, however, the worker is offered the possibility of traveling by private transport, in accordance with government recommendations, but must do so assuming the cost difference. In other words, the company will only pay for travel expenses the amount that would correspond if the trip were by public transport, having to assume the extra cost the worker (In the event that there is no possibility of taking a trip on public transport, the company’s travel policy regarding its management is maintained)

Continue promoting the search for options or ways to complete the work activity full time during the telework period, such as collaborations with other departments, for the operation of training plans, HR, quality, and online training.

Financial measures

We have applied the Paid Licence or Hours Pool system in which the hours not worked during the alarm and teleworking period are accumulated to be recovered before the end of the year.

A document annexed to the workers’ agreetment will be provided to establish this commitment.

The suspension of the bono extra payments until the financial conditions allow the payment.

In order to reduce structural costs as much as possible, we have decided to maintain the teleworking policy until a relatively normal situation can be met, and all our offices (León, Madrid, Turin and Rome) will remain closed until the risk contagion is reduced.

Communication measures

We are using creative methods to feel connected, stay involved and contribute to building an online culture, with meetings or virtual coffees, web-based communications of the measures and activities taken, as well as marketing actions aimed at generating an optimistic spirit to overcome the situation.

We continue to collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. We are very grateful that they have shared their concerns and plans with us, and for communicating to us what their current needs are. Crises demand and generate innovation (eg, process redesign, system automation, team cohesion, and more). Our goal is not only to get out of this situation safely, but to make it stronger.

This type of planning requires a high level of transparency from each party involved, allowing us to anticipate and anticipate possible challenges.

Proactively design new ways to collaborate with our clients.

Since the beginning of this pandemic, a close contact has been maintained with all employees, customers and suppliers.

Our commitment and effort is essential to continue offering our services with the least possible impact, transmitting and adopting the necessary preventive measures and the measures adopted for the continuity of activities for ongoing clinical studies or new proposals.

Fortunately, all employees are safe and healthy, and all of them continue to work with the same dedication.

During the teleworking activity, no impact was observed on our operational capacity.

We will continue working to define critical services and determine the necessary actions to guarantee their continuity. The different areas are still fully operational and provide services with complete normality.

General Measures May 4th, 2020

After the last financial analysis carried out by the Direction where the income and expenses of the first quarter are analyzed, the Direction comunicated the measures adopted by e-mail on April 15 related to the continuity of the organization and avoid resorting to the application of Temporary Employment Regulation Process (ERTE) or any other measure aimed at reducing personnel, and among these measures are:

  • The application of application of the Paid Licence or Hours Pool system that will be described, so that the hours not worked during the alarm and teleworking period are accumulated to be worked before the end of the year; or
  • The suspension of the bono as summer extra payments until the financial conditions allow the payment. As previously indicated, a document annexed to the workers’ agreetment will be prepared to establish this commitment.
  • Lastly, the aim is to reduce structural costs as much as possible so that other costs that are considered more relevant, such as personnel costs, can be met, and it has been decided to maintain the teleworking policy until a relatively normal situation can be re-established, and all offices (León, Madrid, Turin and Rome) will remain closed until the risk of contagion is reduced

It is also specified that the search for options or ways to complete the work activity full time during the teleworking period should be encouraged, such as collaborations with other departments, on-line training … look for new ideas among all to change the monitoring model towards a model of remote assistance to sites and researchers, to work on the operation of training plans, HR, quality, etc.

The specific prevention measures against COVID-19 are being agreed in collaboration with the external Occupational Risk Prevention Service for all personnel in their own work centers, as well as for personnel who must travel to research site, or any other, due to their activity. They will be communicated in writing to each worker once it is approved for information and compliance by both the company and the workers.

In accordance with these prevention measures, various vendors will be contracted to offer the Individual Protection Equipment and services of diagnostic tests for workers.

León Research will maintain the activity through teleworking during the period considered, regardless of the state of alarm decrees of each Country, for the benefit of the health of the workers and the continuity of the business.

The return to the respective offices will be based on the global evolution of the situation generated by the pandemic, the circumstances of the company, and will always be progressively, taking into account when normal activity can be resumed as a CRO.

All employees continue their activity by teleworking and no impact on our operating capacity has been observed.

Our sector is recognized as an essential activity, so we continue with our activities, transmitting and adopting the appropriate preventive safety measures and the measures adopted for the continuity of activities for ongoing clinical studies or new proposals.

We have updated the Guidances to manage Clinical Trial during COVID-19 that includes the latest measures adopted for the management of clinical trials with the recommendation and guidelines of the European Medicines Agency (EMA), version 3 of 28 April 2020, as well as the latest published local recommendations from the competent authorities of each country as complementary measures to those of the EU.

The PMs will continue informing all the clients involved about the measures to follow in the management of clinical trials during this special situation. We take the opportunity to confirm if these measures are already being addressed at the CRO Sponsor level and if we can collaborate with our contribution by offering each required activity that is contemplated in the UE and local guides, such as conducting the risk assessment, the contingency plan and timely regulatory notifications.

Committed to adapting to the new situation, using creative methods to feel connected, stay involved and contribute to building an online culture that helps us all, with virtual meetings and web-based communications of the measures taken and activities, as well as marketing actions aimed at generating an optimistic spirit to overcome the situation.

As in the communication of the past few weeks, our global operations continue to provide service and that the impact on our capabilities and service levels has been minimal.

We will collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. This type of planning requires a high level of transparency from each involved part, which allows us to anticipate and anticipate possible challenges.

We have spoken to many of our clients about the Business Continuity Plan (BCP) and we are very grateful that they have shared their concerns and plans with us, and for communicating to us what their current needs are. This allows us to proactively design new ways to collaborate with our clients. Crises demand and generate innovation (eg, process redesign, system automation, team cohesion, and more). Our goal is not only to get out of this situation safely, but to make it stronger.

Since the beginning of this pandemic we have maintained close contact with all employees, customers and suppliers. Our commitment and effort is essential to continue offering our services with the least possible impact. Fortunately, all employees are safe an d healthy, all of them continue to work with the same dedication.

General Measures April 15 th, 2020

We are following the latest measures adopted for the management of clinical trials with the recommendation and guidelines of the European Medicines Agency (EMA), as well as the latest published local recommendations from the competent authorities of each country as complementary measures to those of the EU.

PMs have informed all the clients involved about the measures to follow in the management of clinical trials during this special situation. We take the opportunity to confirm if these measures are already being addressed at the CRO Sponsor level and if we can collaborate with our contribution by offering each required activity that is contemplated in the UE and local guides, such as conducting the risk assessment, the contingency plan and timely regulatory notifications.

Nevertheless, since the coronavirus emergency situation and containment measures are likely to last for a prolonged period, several NCAs have started to look into temporary options related to remote access and conditions for such, providing that methods can be used that restricts access to participants’ trial records, in line with the principles of necessity and proportionality. This should however also be clarified with other relevant authorities in this area (such as, without limitation, Ethics Committees and data protection agencies) and is consequently not allowed unless a member state has given specific guidance allowing this.
Until now, no Competent Authority has issued a specific guide, and consultations must be carried out with the DPOs of the sites and the Data Protection Agencies of each country, to define the procedures to be followed as CRO in monitoring activities.

All our facilities are closed, even so our sector is recognized as an essential activity, for this reason we continue with our activities, transmitting and adopting the appropriate preventive safety measures and the measures adopted for the continuity of activities for ongoing clinical studies. or new proposals.

All employees continue their activity by teleworking and no impact on our operating capacity has been observed.

León Research management board encourages compliance with these measures and home confinement for the good and safety of all, except in situations allowed by the authorities of each country.

Committed to adapting to the new situation, using creative methods to feel connected, stay involved and contribute to building an online culture that helps us all, with virtual meetings and web-based communications of the measures taken and activities.

In view of the occurrence of a change in the alarm situation of each country in the next weeks, Leon Research will encourage continuing with the activity by teleworking, and the return to the respective offices will be progressive, as well as normal activity will be adapted little by little depending on each circumstance.

As in the communication of the past few weeks, our global operations continue to provide service and that the impact on our capabilities and service levels has been minimal.

We will collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. This type of planning requires a high level of transparency from each involved part, which allows us to anticipate and anticipate possible challenges.

General Measures April 3rd, 2020

We are following the latest measures adopted for the management of clinical trials with the recommendations and guides of the European Medicines Agency (EMA), version 2 dated on March 27, 2020, and some local recommendations of the competent authorities. Please click below to read them.

All our offices are closed by order of local governments, but even so, our sector as a recognized essential activity, we continue with our necessary activities, transmitting and adopting the appropriate preventive measures.

All employees continue their activity by teleworking and no impact on our operating capacity has been observed.

León Research management board encourages compliance with these measures and home confinement for the good and safety of all, except in situations allowed by the authorities of each country.

We are committed to adapting to the new situation, using creative methods to feel connected, stay involved and contribute to building an online culture that helps us all, with virtual meetings and web-based communications of the measures taken and activities.

In view of the occurrence of a change in the alarm situation of each country in the next few days, Leon Research will encourage continuing with the activity by teleworking, and the return to the respective offices will be progressive, as well as normal activity will be adapted little by little depending on each circumstance.

As in the communication of the past few weeks, our global operations continue to provide service and that the impact on our capabilities and service levels has been minimal.

We will collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. This type of planning requires a high level of transparency from each involved part, which allows us to anticipate and anticipate possible challenges.

All employees will have a few days of vacation during the Easter period from April 6 to 13, paying the correct attention to the mobile phone in case of any urgent need.

General measures March 25th, 2020

Proper communication will be maintained with both suppliers and clients about updates to these measures.

We suspend of all face-to-face training activities, both internal and external.

All possible activity will be maintained through teleworking, guaranteeing communication channels and the fluidity of it (this implies special attention to professional mobile line during the period of continuous teleworking).

In the case of the activities related to the visits necessary for the management of the studies, the instructions of the international, European and local regulatory agencies will be followed for the management of clinical trials, which include remote monitoring and avoiding the performance of any on-site monitoring visit until becomes possible again, and always informing trial sponsors.

All monitors must communicate the modification of any visit by the sites to the Sponsors. Confirmation of cancellation will always be requested in writing and this must be sent to the country’s COM to carry out the appropriate follow-up (for the purposes of possible cancellation costs and subsequent billing follow-up). All monitors will consult with sites and Sponsors about the possibility of carrying out remote monitoring to compensate for the cancellations suffered.

At the date of this measure, the trips to, or that passes through places declared as a focus and high risk will be avoided as far as possible, following the recommendation of the government of each country,

Any worker who is exposed to contagion, either by visiting a hospital, or a work trip, must notify it and keep the quarantine period of up to 17 days before having contact with third parties. This situation must also be reported in the event that exposure to contagion occurs outside of work functions.

In the event that any employee of the operational departments gets the disease, there will be a back-up previously formed in the study to be able to continue the activity. In the case of not having a backup, a substitute will be determined by Leon Research and this decision communicated to the sponsor. In the event that any employee with functions in internal departments gets the disease, it will be determined by Leon Research, and may decide to distribute the tasks among members of Leon Research to assume those functions.

Since the activity will be reduced in the coming weeks, it has been considered to apply teleworking as much as possible and in a second step the application of the Paid Licence or Hours Pool system to adapt to productive needs when possible.

Regarding the Easter Holidays period that was already indicated as the vacation period assigned by the company, it remains as such for all employees regardless of whether the employees have requested the enjoyment or exchange thereof.

SPECIFIC MEASURES FOR SPAIN

June 1st, 2020

Royal Decree 537/2020, of May 22, extending the state of alarm declared by Royal Decree 463/2020, of March 14, declaring the state of alarm for the management of the health situation caused by COVID-19.

The duration of this alarm state is extended until 00:00 hours of June 7 of 2020, and with the expectation that there will be more extensions until the end of the de-escalation phases, depending on the evolution of the pandemic, and of infections that may occur throughout the country, and may be expanded by the government in the coming week.

“Plan for transition to a new normality” in which the de-escalation plan is explained, including an annex detailing the characteristics of the lifting of limitations for each sector and field of activity are described.

Operation of the de-escalation plan, for the resumption of work activity:

  • The measures adopted will depend on the phase status of each territory.
  • This plan has 4 phases. Each phase lasts two weeks. These dates are not fixed and may change if, for example, the number of people infected with coronavirus increases.
  • The phase changes are published by the Ministry of Health, depending on the criteria and indicators for the change to the next phase.
  • An important measure is that people cannot leave their provinces until phase III, but they can move to other provinces for work reasons.

The entire national territory is between phase I to phase III, specifically the province of León and Madrid are in Phase I.

Consult the general measures adopted and the activities allowed in each phase for the different provinces.

As of July 1, it is anticipated that intra-community travel will be permitted without a quarantine period of 14 days after arrival.

Related to investigational studies management

Updating documentGuidances to manage clinical trial-COVID-19_No.5_01June2020” gathers the information contained in the guidelines with the specificy measures for clinical trials management in Spain, issued by Spanish Agency of Drugs and Medical Devices (AEMPS), on 4 May 2020.

Actions of the AEMPS to speed up and promote clinical trials and observational studies on COVID-19” Date of publication: 4 May 2020.

 The applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

At the time of this update any review of the AEMPS issued measures has been made.

The latest Q&A document from the AEMPS meeting with AECIC is provided to the operations team.

The AEMPS will conduct remote Good Pharmacovigilance Practice inspections due to the COVID-19 Document published on 28 May 2020.

May 4th ,2020

Essential and non-essential activities restart on April 13th of 2020 based on alarm state decreed in RD 462/2020 of March 14th, for the management of the health situation caused by COVID-19.

The duration of this alarm state will be extended, through a new RD published on April 25th, until 00:00 hours of May 10th of 2020 based on the pandemics development and on the possible infections that may happen in this country, it could be extended again by the Government the next weeks (15 more days). All measures implemented in the decree and mentioned in the last update of this annex of March 16th, are still in force.

The Spanish Government has published the document “Plan para la transición hacia una nueva normalidad” (Plan for transition to a new normal)” in which it is explained the de-escalation plan, including an annex in which characteristics for the restrictions lifting for each sector and part of activity are described.

The fundamental aim of the de-escalation plan is to achieve a gradual recovery of economic activity and daily lives, minimizing the risk coronavirus COVID-19 epidemics represents for public health. The back to normality will require maintaining for more time the socioeconomic mitigation measures in order to recover productive activities and employment of the most affected sectors.

In the published text, it is indicated that if the available data on the evolution of the disease conclude at the end of the period of validity of this third extension that the containment measures allow the objectives set for this new phase to be reached, “a scenario of gradual lifting of the extended measures ”

The de-escalation of the lockdown will have 4 phases beginning on May 4th and will last at least eight weeks, until the end of June. Each phase will last 2 weeks and we will move to the next phase if health indicators show that it is possible to go on.

All the measures will be enforced by provinces or islands and their enforcement will end at the ending of June, when, if everything goes ok, it will be considered that the “new normality” has been reached, if the epidemics have been controlled in all territories.

Transition will be gradual asymmetrical, coordinated with the autonomous communities and adaptative, the different phases will not last the same period in the whole country, avoiding the possible collapse of the National Health System.

Movements between provinces will not be allowed until the end of June, with the exceptions considered in the decree. The control measures and the preventive materil use will continue in this normality stage.

Details of the phases and activities allowed are stablished in the Annex II of the Plan made by Spanish Government.

Particular dates and real evolution will depend on the pandemic’s behaviour and control, as well as the capacity for accomplishing the different phases with the conditions established in the Plan

  • Phase 0 begins on May 4th, it is the preparation for the transition, in all provinces with the exception of some islands that begin at phase 1.

Phase 1 will begin on May 11th in the provinces that fulfil the requirements.

Common regime applied to all activities:

  • Any allowed activity will be developed with security measures, self-protection and social distancing. Face masks use outside home is convenient and highly recommended when social distancing can´t be granted. Also, availability and access to hydroalcoholic solutions should be facilitated in order to practice frequent hand hygiene.
  •  All locals and other places, as well as their equipment, related to allowed activities must be periodically disinfected and sanitized.
  • In a general way, until new normality has ben reached after accomplishing phase III, travelling to other provinces different from the one in which the person lives will not be allowed, except for justified causes. Once in the new normality stage, travelling between provinces will be allowed if both of them have passed the phase III.
  • Any activity and its limitations, shown on the document annexed table (annex II; Guiding forecast for the lifting of the national limitations established in the state of alarm, depending on the phases of transition to a new normality), will be still in force in the following phases of the de-escalation, unless new different limitations are told.
  • Travels made, whichever the vehicle it is, must be for the realization of the allowed activities.

Summary of the “Plan for the transition to a new normality”, published on April 28th by the Health Ministry:

Phase 0, preparation for the de-escalation

This is today´s situation, characterized by the stablishing of common relieve measures for all the country once the infection curve has ben flattened, allowing mobility outside the house, mainly for private issues, with measures that reduce the infection risk to the minimum, only when safety indications are fulfilled, based on the citizen´s responsibility and self-protection (contactless individual sport activities and walks, care of family gardens, some economic activities with capacity control, etc.).

During this phase measures that would affect only to particular territories could be adopted.

Particularly, isolated and low infection risk islands.

Phase I or initial

Depending on the fulfilling of the different territories of the indications shown on the Indications Panel it will be allowed the partial opening of some activities, particularly, economic activities such as minor commerce opening with  previous appointment or counter service, restaurants and coffee shops with takeaway delivery, agricultural activities, professional sport activities, touristic accommodations with restrictions and common grounds not allowed, among other activities.

Phase II or intermediate

In this phase it would be possible to partially reopen activities limited in phase I, with place limitations, such as restaurants with table and terrace service, common places of touristic accommodations, big department stores, etc.

Phase III or advanced

In this phase, opening of all activities is foreeen, but always keeping appropriate safety and distance measures.

Among the measures to be considered in this phase, reopening of minor commerce that hadn´t previously opened, with limited capacity, pubs and discos with very limited capacity, museums and cultural shows with limited capacity too, etc

New normality

Economic and social restrictions end, but epidemic surveillance does not, as well as the reinforced capacity of National Health System and citizen´s self-protection

Related to investigational studies management

  • In updated document “Guidances to manage clinical trial-COVID-19_No.4_04May2020” it is shown the last onformation provided by the guide with the specifical measures for clinical trials management in Spain, issued by Spanish Agency of Drugs and Medical Devices (AEMPS), on April 7th of 2020.

The applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

  • At the time of this update any review of the AEMPS issued measures has been made.
  • Work still goes on with the Spanish Data Protection Agency (AEPD) regarding inquiries made to specialized inspectors for the management of patient data in remote activities for trials management.
  • Based on the responses obtained by our Data Protection service (Atico34), if the data are anonymized, the data protection regulations would not be breached, since the anonymized data is not personal data. They have provided us with the GDPR-based data anonymization procedures guide, which will continue to be studied to define the procedures to be followed as a CRO.

April 15th ,2020

The essential and non-essential activities are resumed as of April 13, 2020, based on the state of alarm decreed in RD 462/2020 of March 14, for the management of the health situation caused by COVID-19.

Our activity is considered essential activity for the measures adopted within Pharma sector.

As of the date of this update, the duration of the alarm state and confinement is extended until 00:00 on April 26, 2020, depending on the evolution of the pandemic, and the contagions that may occur throughout the country, and may be extended by the government for more weeks.

The measures implemented in the decree mentioned in the last update to this annex of March 16, 2020 are maintained.

The updated document “Guidance to manage clinical trials- COVID-19_nº3_15April2020” contains the latest information contained in the guide with specific measures for the management of clinical trials in Spain, issued by the Spanish Agency for Medicines and Health Products (AEMPS) on April 7, 2020. The measures applied will be communicated to all the parties involved, as well as to the promoters who request it, and considering all subsequent updates if the case arises.

The Spanish Data Protection Agency (AEPD) has issued several reports regarding the treatment of data in the COVID-19 situation, but they have not been so specific for the management of trials, so it is expected to obtain a clear answer in the following consultations with specialized inspectors.

Based on the responses obtained by our Data Protection service (Atico34), if the data is anonymized, the data protection regulations would not be breached, since the anonymized data is not personal data. It has provided us with the GDPR-based data anonymization procedures guide, which will be studied, and we will continue working on defining the procedures to be followed as a CRO.

We are still waiting for a response to the query made to EC / CA about the suitability and possibility of obtaining scanned and anonymized Source Documents to be able to perform SDV remotely.

April 03rd ,2020

On March 28, 2020, the government notified of the state of total confinement until April 09, 2020, based on the state of alarm decreed in RD 462/2020 of March 14, for the management of the health crisis situation caused by COVID-19.

Our activity is considered essential activity for the measures adopted within Pharma sector.

As of the date of this update, the duration of the alarm status is maintained until April 12, 2020, depending on the evolution of the pandemic, and the contagions that may occur throughout the country, and may be extended for more weeks.

The document “Guidances to manage clinical trial-COVID-19_No.2_03Apr2020” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Spain, issued by the Spanish Agency for Medicines and Medical Devices (AEMPS) on March 16th, 2020. The local applied measures will be communicated to all the parties involved, as well as to the sponsors who request it, and taking into account all subsequent updates if the case arises.

No update to the guidelines issued by the Spanish Agency for Medicines and Medical Devices (AEMPS) on March 16th, 2020 with specific measures for the management of clinical trials in Spain until till date.
We are waiting for a response from the Spanish Agency for Data Protection (AEPD) regarding the point of view of the monitoring of source documents versus GDPR.

We are waiting for a response to the query made to EC / CA about the suitability and possibility of obtaining scanned and anonymized Source Documents to be able to perform SDV remotely.

Previous update of March 25th, 2020

On March 22nd, 2020, the government notified an extension of the alert state, which was declared in Royal Decree 462/2020 of March 14th, for the management of the health crisis situation caused by COVID-19.

The duration of the alarm state is extended until April 11th, 2020 depending on the evolution of the pandemic, and the contagions that may occur throughout the country.

EC / CA have been questioned about the suitability and possibility of obtaining scanned and anonymized Source Documents to be able to perform SDV remotely.

EC / CA have been asked about the suitability and possibility of contracting an external provider that can carry out the clinical trial visits (including obtaining and processing samples). A potential vendor has been identified and will be contacted if approved.

At the date of this measure, all trips to, or that passes through places declared as a focus and high risk (Community of Madrid, Catalonia, the Basque Country and La Rioja) will be avoided in as much as possible following the recommendation of the Ministry of Health.

Previous update of March 16th, 2020

On March 13th, 2020, in the afternoon, the alert state in Spain was decreed by the government, pending to know the latest measures adopted by the authorities.

On March 14th, Royal Decree 463/2020 of March 14th was published, declaring the state of alert for the management of the health crisis situation caused by COVID-19. Entering into force at 00:00 on Sunday March 15th.

The declaration of alert status affects the entire national territory.

The duration of the state of alert that is declared by this royal decree is fifteen calendar days. Some of the measures implemented in the decree that could affect us in our activity:

  • Limitation of people’s freedom of movement.
  • During the state of alert, people may only circulate along the roads for public use for the following activities:

a) Acquisition of food, pharmaceutical products and essential necessities.

b) Assistance to health centres, services and establishments.

c) Travel to the workplace to carry out the professional activity.

d) Return to the place of habitual residence.

e) Assistance and care for the elderly, minors, dependents, people with disabilities or especially vulnerable people.

f)  Attending to financial and insurance entities.

g)  Due to force majeure or need.

h) Any other activity of a similar nature must be done individually, unless accompanied by people with disabilities or for other justified cause. The circulation of private vehicles is also allowed on public roads to carry out these permitted activities or to refuel.

  • Containment measures in the workplace, facilitating teleworking and suspension of face-to-face educational activity in all cycles while maintaining online activity.
  • Containment measures in the field of training, during the suspension period, educational activities will be maintained through distance and online modalities, whenever possible.
  • Containment measures in the field of commercial activity, cultural facilities, recreational establishments and activities, hotel and restaurant activities, and other additional activities. The opening of bars, catering establishments, discotheques, cultural and leisure facilities, sports venues, amusement parks, auditoriums is suspended, and open-air dances, parades and popular parties or folkloric demonstrations in open venues are prohibited.
  • Limitations on trade, all establishments will be closed except for pharmacies, kiosks, tobacconists, gas stations, orthopaedics, dry cleaners, opticians, medical centres, food markets, technology, and animal feed.
  • In this way, crowds will be avoided, and consumers and employees will be controlled to maintain the safety distance of at least one meter in order to avoid possible contagion.
  • Measures to ensure the supply of goods and services necessary for the protection of public health.
  • Transport measures. 50% reduction in the supply of trains, air transport and road transport and the frequency are limited. To guarantee distance, only one third of the maximum available places will be put up for sale.
  • Failure to comply with the state of alert is fined from 100 euros to 3 months in prison (for the crime of disobedience) or up to 4 years in prison (for attack towards the authority).

SPECIFIC MEASURES TO PORTUGAL

June 1st, 2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The state of alert was declared finished on May 04th, 2020.

After the epidemiological situation of COVID-19, the calamity situation was declared throughout the national territory until 11:59 pm on May 31, 2020, without prejudice to the extension or modification as an evolution of the epidemiological situation or justification

By Resolution of the Council of Ministers No. 33-C / 2020, of April 30, 2020, a gradual strategy is approved to lift the containment measures against the pandemic of the disease COVID -19 and the schedule of the strategy to survey containment measures with a 15-day period between each deflation phase to assess the impact of the measures on the evolution of the pandemic.

These measures are as follows:

General conditions:

  • Availability of masks and disinfectant gel for sale / Regular hygiene of spaces / Maximum reduced capacity / Hand hygiene and respiratory label / Physical distance (2m).

Planning:

Related to investigational studies management

Updating the document Guidances to manage clinical trial-COVID-19_No.5_01June2020” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020 including the review carried out on April 3, 2020. CEIC fully adopts the EMA recommendations published in: Eudralex10: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic – Version 3, revised on April 28, 2020.

CEIC as a member of EUREC released the document “Position of the European Network of Research Ethics Committees (EUREC) on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic” on May 15, 2020.

Also included is the update of the document “COVID-19: Exceptional measures within the scope of Clinical Trials during the period of risk to public health (Version 3 dated 11/05/2020) published by INFARMED.

The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and considering all subsequent updates if the case arises.

May 4th ,2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The state of alert will be declared finished on May 04th, 2020.

The government declares confinement from April 30 to May 04 in the areas of residence.

By Resolution of the Council of Ministers No. 33-C / 2020, of April 30, 2020, a gradual strategy is approved to lift the containment measures against the pandemic of the disease COVID -19 and the schedule of the strategy to survey containment measures with a 15-day period between each deflation phase to assess the impact of the measures on the evolution of the pandemic.

These measures are as follows:

  • General conditions: Availability of masks and disinfectant gel for sale / Regular hygiene of spaces / Maximum reduced capacity / Hand hygiene and respiratory label / Physical distance (2m).
  • Planning:

Related to investigational studies management

  • Updating the document Guidances to manage clinical trial-COVID-19_No.4_04May2020” that gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020 including the review carried out on April 3, 2020. CEIC fully adopts the EMA recommendations published in: Eudralex10: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic – Version 3, revised on April 28, 2020.
  • Also included is the update of the document “COVID-19: Exceptional measures within the scope of Clinical Trials during the period of risk to public health (Version 2 dated 15/04/2020) published by INFARMED.
  • The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and considering all subsequent updates if the case arises.

April 15th ,2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The duration of the declared state of alert is extended to 17 April, 2020 and it will be extended possibly until 1 May, 2020.

The government has issued recommendations for the use of protective masks as preventive measures

The updated document “Guidance to manage clinical trials- COVID-19_nº3_15April2020” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020 including the review carried out on April 3, 2020.
The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and considering all subsequent updates if the case arises.

April 03rd ,2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The duration of the declared state of alert is extended to 17 April 2020.

The government declares confinement in the areas of residence from 9 April to 13 April, in addition as measures, declares social distancing, no more than 5 people and the airports will remain closed.

The document “Guidances to manage clinical trial-COVID-19_No.2_03Apr2020” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020. The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and taking into account all subsequent updates if the case arises.

Previous update of March 25th, 2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The duration of the declared state of alert is fifteen calendar days.

On March 22nd, Decree No. 2-A / 2020 of March 20th entered into force, regulating the application of the state of emergency decreed by the President of the Republic to manage the crisis situation health caused by COVID-19. It came into force at 00:00 hours on March 22nd. It has been rectified by Rectification Declaration No. 11-D / 2020 of March 22nd, 2020.

SPECIFIC MEASURES FOR ITALY

June 1st, 2020

The DPCM Decree signed on April 26, 2020 includes the instructions and directives for Phase II that will start on May 04, 2020.

As a summary, the activities allowed and not allowed as of May 4, 2020 are listed below. Our activity is considered essential activities for the measures adopted within the pharmaceutical sector.

Phase II – Allowed activities:

  • Visit family members and Friends who live in your same region;
  • Move from one region to another only for proven reasons of work, health and absolute urgency;
  • Return to your own home or residence;
  • Do individual physical activity outdoors and away from home;
  • Professional training and individual sports;
  • Go to parks and gardens;
  • Attend funerals (max 15 people);
  • Reopen construction sites.
  • Go to the second houses;
  • Eat in restaurants, bars and places in general;
  • Go to the hairdresser or beauty centers;
  • Make purchases in stores;
  • Go to mass in churches with a mask.

Phase II – Activities NOT allowed:

  • Make private parties;
  • Use the play areas in public parks and gardens;
  • Go to museums or libraries;
  • Use public transportation without a mask;

Related to investigational studies management

Updating the document Guidances to manage clinical trial-COVID-19_No.5_01June2020” gathers the information contained in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on April 7, 2020, version 2.

The local applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

At the time of this update any review of the AIFA issued measures has been made.

May 4th ,2020

The DPCM Decree signed on April 26, 2020 includes the instructions and directives for Phase II that will start on May 04, 2020.

As a summary, the activities allowed and not allowed from May 4, 2020 are listed below.

Phase II – Allowed activities:

  • Visit family members who live in your same region;
  • Buy food and drinks to take away without consuming them in front of the locals to avoid the formation of groups of people;
  • Move from one region to another only for proven reasons of work, health and absolute urgency;
  • Return to your own home or residence;
  • Do individual physical activity outdoors and away from home;
  • Professional training and individual sports;
  • Go to parks and gardens;
  • Attend funerals (max 15 people);
  • Reopen construction sites.

Phase II – Activities NOT allowed:

  • Visit friends, make family gatherings and private parties;
  • Go to the second houses;
  • Eat in restaurants, bars and places in general;
  • Use the play areas in public parks and gardens;
  • Do sports activities in group or 1 vs 1;
  • Go to museums or libraries;
  • Use the public transport without a mask;
  • Go to the hairdresser or beauty centers (they will remain closed until June 1, 2020);
  • Make purchases in stores (stores which are considered non-essential will remain closed until May 18, 2020);
  • Go to mass in churches.

Related to investigational studies management

  • Updating the document Guidances to manage clinical trial-COVID-19_No.4_04May2020” that gathers the information contained in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on April 7, 2020, version 2. The local applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.
  • At the time of this update any review of the AEMPS issued measures has been made.

April 15th ,2020

The DPCM Decree signed on April 10, 2020 officially extends the duration of the state of alarm and confinement until 3 May,2020 and confirms that all industrial and commercial production activities are suspended, with the exception of those considered essential.

Our activity is considered as essential activitites for the measures adopted within Pharma sector.

The updated document ” Guidances to manage clinical trial-COVID-19_No.2_03Apr2020” gathers the information contained in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on April 7, 2020, version 2.
The local applied measures will be communicated to all parties involved, as well as to the sponsor who request it, and taking into account all subsequent updates if the case arises

The action procedure included in the contingency plan for the different scenarios was adopted for one employee who has symptoms of disease during her teleworking activities. The measures have been adopted in the benefit of the worker’s health and the health and safety of the rest of employees, if the case arises.
The procedure to get a back up is activated and the impact in the spceific activities has been minimal.

April 03rd ,2020

The government has extended the duration of the state of alarm until April 13, 2020 and possible extension until May 2, 2020.

The DPCM Decree signed on March 22, 2020 establishes that all industrial and commercial production activities are suspended, with the exception of those considered essential.

Our activity is considered as essential activitites for the measures adopted within Pharma sector.

The document “Guidances to manage clinical trial-COVID-19_No.2_03Apr2020” contains the information including in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on March 12, 2020. The local applied measures will be communicated to all parties involved, as well as to the sponsor who request it, and taking into account all subsequent updates if the case arises.

No update to guide issued by AIFA on March 12, 2020 with specific measures for the management of clinical trials in Italy until till date.

The action procedure included in the contingency plan for the different scenarios is adopted for one employee who has symptoms of disease during her teleworking activities. The measures will be adopted in the benefit of the worker’s health and the health and safety of the rest of employees, if the case arises.

The procedure to get a back up is activated and the impact in the spceific activities has been minimal.

Previous update of March 25th, 2020

New DPCM Decree signed on March 22nd, 2020. Whose Decree establishes that:

  1. All industrial and commercial production activities are suspended, with the exception of those considered essential.
  2. It is forbidden for everyone to move by public or private means of transportation to a different municipality from the one they are currently in, except for proven work or absolute emergency needs or for health reasons. The authorization for returning home is cancelled.
  3. The production activities that would be suspended in accordance with letter a) may in any case continue if they are organized remotely or telework.
  4. Public utility services are still allowed, as well as essential services. It is maintained the suspension of services open to the public, such as museums and other cultural institutes and places, as well as services related to education when they are not provided remotely within the limits currently allowed.
  5. The production, transportation, marketing and delivery of medicines, health technology and medical-surgical devices, as well as agricultural and food products, are still allowed. Any activity that is functional to deal with the emergency is also allowed.
  6. The activities of the aerospace and defence industry are permitted, as well as other activities of strategic importance for the national economy, subject to the authorization of the Mayor of the province where the production activities are located.

The workers located in the Italian office, in Turin, have been teleworking since March 9th, 2020 and, according to the directives of the Italian Government, will continue to do so until April 3rd, 2020.