Setting Up COVID-19 Clinical Trials During the Pandemic
Setting-up COVID-19 clinical trials during the pandemic has forced all stakeholders to think outside the box and beyond their comfort zone. In this unforeseen situation, it is important to be flexible and learn quickly while adapting to the new paradigms.
During this presentation we will present SGS’s experiences and perspective, as well as the lessons we have learned in setting up COVID-19 clinical trials during the pandemic. Our experts will present hands-on examples, and discuss issues and mitigation plans.
- Regulatory activation process
- Site selection and activation
- Protocol development
- Study set-up
SGS serves pharmaceutical, biopharmaceutical and medical device companies along the entire drug development pathway.
With over 40 years’ experience as a global contract service organization, SGS provides integrated (bio)pharmaceutical development and testing solutions, including:
- Clinical research
- Pharmaceutical development
- Biologics characterization
- Biosafety and quality control testing for small and large molecules, raw materials, containers and finished products
SGS provides clinical research and bioanalytical testing, with a focus on early stage development and biometrics. Delivering solutions in Europe and North America, SGS offers clinical trial services.
SGS has its own clinical unit in Belgium, including a viral challenge testing facility and two phase I patient units based in Belgium and Hungary. SGS has a wealth of expertise in FIH studies, viral challenge testing, biosimilars and complex PK/PD studies with a high therapeutic focus in infectious diseases, vaccines, and respiratory:
- Drug development consultancy
- Clinical pharmacology unit
- Clinical trial management in Europe and Americas
- Biometrics – data management, statistics, PK/PD and medical writing
- PK/PD modeling and simulation
- Regulatory and pharmacovigilance
For further information, please contact:
t: +32 15 27 32 45