With the increasing complexity of today’s clinical trials, as well as the speed of technology innovation, the unique issues have emerged especially in the area of clinical trials and the use of electronic systems. Understanding regulations - particularly the principles and intent of those regulations - and being able to apply them to new technology and processes in clinical trials, is critical to a company’s success. Novel approaches to safeguard data integrity and human subjects need to be considered.
This unique course provides a practical & in-depth understanding of electronic systems and technologies used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality concerns.
Join us online live & learn, how a quality department can actively enable digital innovation in clinical trials & ensure the highest regulatory compliance at the same time.
IRT managed under GCP regulation
ePRO requirements, audit targets & inspection observations
eConsent strategy & key considerations for compliance
EDM systems best practices
ELM systems quality compliance
eTMF inspection readiness
Providers of systems – issues to be aware of
Audit trails of systems