Assuring Outsourcing Obligations With Specialist Data Management Oversight

By Alla Muchnik, Senior Clinical Data Manager, Cytel

The International Conference on Harmonization (ICH) E6 R2 states “Ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.” Therefore, the sponsor must manage vendors in a fashion that ensures quality, integrity, and reliability. Not only is this ICH statement essential for the sponsor to adhere to, but it must also be at the forefront of vendors’ working practices when considering the quality of documentation and deliverables. Documented processes should be followed to ensure that quality data is received from vendors, as well as to evaluate vendor services consistently.

In this blog, Alla Muchnik, Senior Clinical Data Manager at Cytel, discusses how specialist CROs can add value and streamline processes by providing oversight of data management services delivered by another CRO. This model helps to fulfill essential regulatory obligations for biopharma companies who may lack their own internal oversight resources.