IDMC Tips to Help You Prepare

IDMC Tips to Help You Prepare

Tips for preparing for an IDMC Written by Anu Matthew What is an IDMC? An Independent Data Monitoring Committee (IDMC) is a group of experts contracted to review data during a clinical trial. The members are individuals with ‘extensive clinical experience’ (Sartor et...
Black Triangle Scheme

Black Triangle Scheme

Black Triangle Scheme Written by Angus Byrne What is the Black Triangle Scheme? When medicines are first introduced to market, although there has been extensive research done in a clinical environment, it’s known that only the more common adverse events are likely to...
Delivering medical scientist services

Delivering medical scientist services

Delivering Medical Scientist Services Written by Tom Botham Tom’s story of embedding within a client team: In one role a client was in urgent need of a medical scientist to join the team and aid in an important date base lock.  The data base lock was significant as it...
Top Tips for CSR Safety Narratives

Top Tips for CSR Safety Narratives

Top Tips for CSR Safety Narratives Written by Dr Steph Jones CSRs (Completed Study Reports) Whether you are working with an external service provider or creating them in-house the safety narratives always cause a great deal of work right at the end of the study. This...
Signal Management

Signal Management

Signal Management Written by Lucy Platt An introduction to signal management Signal management is a key activity in pharmacovigilance, allowing the identification of new risks associated with a medicine. Manufacturers of medicines and regulatory agencies are...