About Outsourcing in Clinical Trials USA Virtual Conference
The twelfth annual OCT New England event will be turning virtual in September to become OCT USA. This online conference will bring together over 1200 delegates for an intellectually driven two day program which will include high level case study presentations from industry leaders across the US.
Presentation: Risk Based Monitoring Through COVID-19 and Beyond: Advancing Structured Flexibility
Since publication of the ICH-GCP R2 addendum, risk based trial approaches have steadily made their way into the clinical drug development industry. The dynamic nature of risk based monitoring (RBM), with its focus on the most critical areas, makes it a unique asset for tackling today’s trial challenges in COVID-19 times. This presentation will show how applying RBM principles can help you to successfully adapt trial oversight activities to the changing environment and prepare for the future.
- Provide insight into how to adapt trial oversight activities using risk based principles
- Discuss key factors that drive decision making around monitoring strategies
- Offer practical examples implemented during the COVID-19 pandemic
- Background of risk based monitoring (RBM)
- Revising risk management strategies
- Monitoring approaches and considerations
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
To find out more, contact us today.
t: +32 15 27 32 45