The first thing I want you to know is that we are not a big CRO.

We are 46 people in the company.

I don’t know if this will be a problem for you.

We are 46 workers who try to make clinical trials go as smoothly as possible.

 

For many, the best approach to clinical trials is to start as soon as possible, and they put all their efforts and energy on submitting to Ethic Committees and Competent Authorities the sooner the better. It is, of course, very important. But there is also something simpler and available to everyone that will reduce times in your clinical study. More than you think.

Before I tell you what it is, let me begin with a short story to better understand it …

We met the sponsor through a common contact. After a teleconference and some emails, they came to meet us from the US and we immediately got along.

 

As in any relationship, we first laid the foundations: budget, conditions, negotiation and contract.

Then, we started working on a very nice project in advanced therapy. One of those that make you feel proud to be in this sector.

 

After a year working with them, the sponsor told us that they URGENTLY needed a partial closure of the database to obtain the marketing authorization in Europe.

We only had 3 months to include all the data in the CRF, monitoring it and close all queries for 317 patients.

If the report was not ready for the deadline, the study could be terminated.

We had to change the strategy and get to work or we could not reach the deadline.

 

And so we did it.

We went from 2 monitors to 24 people (22 monitors and 2 data entries) working on the study.

The monitoring visits were increased overnight. During 3 months we did on site monitoring EVERY DAY and in many of those we met the 24 of us at the site.

We literally lived in the hospital!

 

Truth be told, it was very stressful.

But it was also very cool, and the well-deserved party we had at the end of this milestone was epic.

I’m not saying everything was perfect. It wasn’t. But we are very proud of the work we did, proud of the team and proud of the response we had.

The sponsor ended up very satisfied and to this day we continue working together on other projects.

     And do you know what we discovered?

     That there is something more important than planning, than strategy and even than tenacity.

     To build strong relationships

Caring for each person who participates in a clinical study. From sponsors, investigators, ethical committees, competent authorities, to our own team and suppliers.

In this case, it was vital to have a team behind that we trust and we could count on them when it was necessary.

It was essential to have the collaboration of the site with which we lived for a while.

And it was necessary to have the sponsor trust and commitment.

In our sector it is very normal to talk about recruitment rates, data, patients, sites, but at the end of the day, behind these figures there are people. Our job as a CRO is to make it easier for all those who are involved in a clinical study.

This approach has helped us to have a good relationship with Ethical Committees and Regulatory Agencies, a large pool of investigators (with whom we have really worked with), a highly effective contract negotiation management and a more human monitoring.

Working like this, allows us to establish a long-term relationship. A lasting relationship, that benefits us all.

 

If you like the way we work, you can email us to info@leonresearch.es.

Yes, I want to contact you

Taking into account that our way of working is based on caring and building a strong relationship with all those involved in a clinical study, here are some facts you will discover and apply if you count on us as your partner CRO:

The most important thing to keep in mind before starting any clinical study and which can determine an important part of the project’s success.

Why working with a CRO will save you time and will make your life easier.

How to know if a country is suitable for your clinical study.

The best strategy to be followed on EC and CA submissions so you can start the trial with the right foot.

The easiest way to have the contract with the site signed in a short time.

By the way, we have a large database of investigators. They are investigators with a name and a face, researchers with whom we have worked and with whom we do not hesitate to contact for new projects or feasibilities.

My mother always says that nobody does things like oneself. But if you have to count on others, there is nothing better than having a CRO with a quick system to identify deviations and let each project flow.

The best way to keep your study data as clean as possible and save time in closing and analyzing the database.

What to do so that monitors are more involved in the project and feel it as their own.

How to get an investigator to find a spot for your monitoring visit when they are very busy.

The system you must have and how to put it into practice for the safety of your study and your patients.

Write us here to work together in your clinical study with the confidence that we have a great team that will be involved in your project from the very first minute.

Yes, I want a budget

Or email us to info@leonresearch.es.

Clinical study design

  • Medical Affairs
  • Medical writing
  • Translations

Sites identification

  • Feasibility
  • Site selection
  • Investigators

Regulatory affairs

  • Ethical committees
  • Competent Authorities

Contract Negotiation

  • Translations
  • Support for negotiation
  • Intermediation

Project Management

  • Planning and follow up
  • Cost control

Recruitment

  • Communication with sites
  • Reports

Monitoring

  • On site and remote monitoring
  • Risk based monitoring

Pharmacovigilance and MD Vigilance

  • SAE and SUSAR management
  • Reports

Data Management

  • eCRF design
  • Queries management

Biostatistics

  • Sample size
  • Statistical analysis

Quality

  • Quality audits
  • Quality check

Archive

  • Study file (ISF) and Trial Master File (TMF)
  • Long term archive

Registry

  • Registration dossier
  • CE mark

Medical Affairs

  • Regulatory strategy
  • Registry procedure

AMP Pharmacovigilance

  • QPPV/Local QPPV
  • Risk Management Plan

How do you build strong relationships?

First of all, by getting involved in the project as if it was ours.

And secondly, with a wide perspective. Although there is always a certain specialization, we believe that it is necessary to maintain a broad approach to have a global vision of the study. This allows us to better understand the scope of the project and to be more committed to it.

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Can you send me a quote?

In order to prepare a basic budget, we need to know, what CRO services you need, and some data such as type of study, therapeutic area, country / countries, number of sites and duration of the study.

Although with this information we can already send you a draft budget, it would be ideal to have a small talk first to find out what you need and thus we will be able to prepare a more complete budget adapted to you.

***

How much does a clinical study cost?

It depends a lot on the type of study and especially on the calendar, but if you send us the protocol synopsis, we can prepare an estimate budget for you so that you can get a general idea.

The more information you provide us, the more detailed the budget will be.

***

What services do you offer?

As CRO we offer the following services for clinical studies on medicinal products, medical devices and nutritional studies:

  • Clinical study design
  • Site selection
  • Ethics committees and Competent Authorities submissions
  • Contract negotiation
  • Project management
  • Monitoring
  • Pharmacovigilance and Vigilance on Medical Devices
  • Data management
  • Bioestatistics
  • Quality
  • Archive

We also offer services for the authorized medicinal products and medical devices:

  • Phase IV and Non Interventional studies
  • Medical Affairs
  • Registry
  • Pharmacovigilance
  • Vigilance on Medical Devices

***

In which countries?

We offer our services throughout Europe. Either directly with our team (in Spain, Italy and Portugal) or through collaborators with whom we maintain a close relationship.

***

What experience do you have?

We have 13 years of experience in which we have worked in more than 200 studies in 800 sites.

Slightly more than half, 55%, in clinical trials (phase 1 to 4), 26% medical devices, 17% observational studies, and 2% in nutritional studies.

We have experience in all therapeutic areas being the most frequent: oncology, ophthalmology, cardiology, traumatology and neurology. We have also worked with a wide number of pediatric and rare disease studies.

***

How long does it take to get approval?

The regulatory strategy to follow could be different depending on the type of study and the objective to be pursued, but in most cases, approval is obtained in 3-6 months.

If you send us the basic information of your study, we can send you an estimate with a better and worse scenario.

***

What tasks are necessary to carry out a clinical study?

Our way of working is simple: after a brief meeting with you, we prepare a budget with all the necessary tasks to carry out the study in the countries selected.

We like to include all the tasks in one document as a very useful way to be aware of the scope of a project, regardless of who does it. Then the budget is reviewed and we decide who is responsible for each task.

Spain, Italy and Portugal will be directly led by our team. Other countries will be managed through collaborators with whom we maintain a close relationship.

***

Does Leon Research have a Quality Management system in place?

Yes. Our quality system is based on ISO standard in compliance with Good Clinical Practices , and within our strategic plan is the implementation of the ISO 9001: 2015 system, for which we are working on the process for obtaining certification in the next year.

In addition we working under the certification on Data Protection according to the General Data Protection Regulation (EU) 2016/679 (EU GDPR), and complying with the principle of proactive responsibility.

***

Is working with Leon Research a good investment?

If you want a real CRO and you prefer to know who you are working with, you may be interested in Leon Research, but nobody better than you to find out if this is what you are looking for.

On our side, we are committed to treat your project as if it was ours.

Click below if you want us to prepare an economic proposal adapted to your specific case.

***

Yes, I want to meet you

Or email us to info@leonresearch.es.

“Thank you for being so committed and for working so hard”

“The PM provided for the project is very committed, dedicated and responsive.
Personal relationship is very good as well”

“I am really glad to work with your CRA and so much appreciate all her efforts”

“Thanks to all of you for your contributions to keep this project within timeline”

If you also want us to help your project to meet timelines, write to us and we will be able to prepare an adapted budget.

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