EMA Guidelines on Computerised Systems: Expert Panel Discussion on Data Integrity and Long-Term Retention in Clinical Trials
Last week we were joined by experts Russell Joyce (from Heath Barrowcliff Consulting) and Matthew Addis (CTO of Arkivum) who discussed the recently published EMA guidelines on computerised systems and electronic data in clinical trials, particularly exploring critical aspects of data integrity and long-term retention.
This discussion explores the critical aspects of data integrity and long-term retention outlined in the guidelines, shedding light on the potential challenges and opportunities that lie ahead for pharmaceutical companies and sponsors.
Topics also included:
- Applying the ALCOA++ principles to the entire clinical trial lifecycle
- Adopting a risk-based approach in validation
- Applying proportionality to GCP regulations
Caitlin Morris
Caitlin is the Content Marketing Manager at Arkivum. She joined the company in 2022 and is responsible for internal and external content creation and management. Caitlin has over 4 years of business and marketing experience.
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