Module 6

04/10/2024

Timeline & Impact

The Organisation for Professionals in Regulatory Affairs

Issues Management or Managed by Issues?

9

Further Examples of the same issue

1. Semler Research Center : In 2016, the EMA recommended the suspension of several medicines based on clinical trials conducted by Semler Research Center in India. An inspection revealed data manipulation and non compliance with Good Clinical Practice (GCP) guidelines. 2. Synchron Research Services : In 2019, the EMA recommended the suspension of over 100 (mainly) generic medicines based on clinical trials conducted by Synchron Research Services, again in India. The inspection found issues with data integrity and compliance with GCP.

These cases continue to highlight the ongoing challenges in ensuring the reliability of clinical trial data, especially when trials are conducted by third party organisations.

The Organisation for Professionals in Regulatory Affairs

10

5