Biometrics Submission Support

Biometrics Submission Support for a Clinical Company It’s the sponsor’s first submission.  The clinical team is experienced and they have regulatory support, but all the Biometrics tasks are outsourced. As a result, no one within the company has the background to evaluate Biometrics deliverables or answer vendors’ questions. This is a frequent scenario in projects... Read more »

Tooling Up and Rounding Out Biometrics

Your Biometrics team is experienced and focused on the pivotal studies and ISE; however, this is their first CDISC submission and the team is overwhelmed. There are legacy studies to be converted to SDTM for the integrated summaries, and documentation to be assembled for the eCTD. Perhaps they have just started to think about the... Read more »

Large Submission, Fully-Outsourced

The sponsor is preparing for its first submission, or perhaps it has been a few years since the previous one. Although the team members are all experienced, this may be their first submission as a unit. Not only has the regulatory landscape changed, but the company has neither the established processes nor the resources to... Read more »