An in-depth look at COA/eCOA strategies and tools, including ePRO, ClinRO and wearables/ sensors, including regulatory aspects and current hot topics (e.g., mixing modes, COVID-19 mitigation, data change requirements). Topics covered during the course will highlight the importance of PRO measurement to drive tailored, patient-centered clinical trials and support regulatory decision making.
This will include best practices for ePRO implementation, leveraging wearables for new endpoints to support labeling claims and regulatory thinking on BYOD.
This interactive course is recommended for those who have experience in clinical trials & patient engagement and wish to develop their skills on how PRO measurement is best implemented to advance patient care.
Mixing modes and COVID-19 mitigation
Licensing & translations
ClinROs and rater training
The course was informative and I learned many new things. The presenters were knowledgeable and engaging. I was unsure how virtual course would work, but it went well. Having the ability for breakout sessions was useful.
Thanks a lot for a great course. I really think you did a great job with the digital version.
Great, intensive course and space for pharma and CRO interactions.
I really enjoyed the small class size for this training. It made the workshop feel very personal and provided the ability to have open conversations and pause for questions. The Protocol Review breakout session was very eye-opening!