A challenging case that tuned out to be a success
Everything started when an intermediator contacted us because they need our help in a paediatric study. After a teleconference to get to know each other and some emails back and forth, we set and signed the contract.
In the beginning, the circumstances in which we had to work were not idyllic, like in most projects: there were some issues in the ISF delivery to the sites, and the Site Initiation Visits were performed without the proper systems, forms and documents and the documentation had problems constantly.
After an audit and some more issues, the sponsor decided to finish their contract with their intermediator and hire us directly as Project Managers of the study.
It was a big challenge because all the control of the documentation and sites falls onto us, but.. do you know what? We did it, we assume the responsibility and management of the study, we adapt our strategy of work to the project needs and put into its disposition our human resources.
There were some errors, like in most projects, but in the end, the sponsor congrats us for the job done and shows its satisfaction.
Today, on clinical trials day, we aim to share with you this study case that was a great challenge but at the same time a success, because it allows us to grow and acquire more knowledge to be who we are today.
While performing a Clinical Trial and achieving success, sometimes we should go through different challenges that complicate our path. But nobody say that it was easy.
In conclusion, all Clinical Trials have their specific requests and their own needs, that´s why at Leon Research we always try to be flexible and adapt to them because every clinical trial is unique and special itself.
We have shared our challenging and successful Clinical Trials but, what about you? Did you experience any unexpected challenges that you want to share with us?