Sponsor Oversight – Proof is in the documents This paper will discuss in detail about the different documents that the biostatistics and statistical programming team at the sponsor can use as evidence to prove sponsor oversight
Vendor Management for a Robust FDA Submission Package: Best Practices . . . Formal communication protocols with predefined escalation pathways minimize timeline disruptions and facilitate prompt issue resolution Knowledge transfer processes between vendors and sponsors ensure prompt response to regulatory inquiries without additional vendor engagement
Agile Sponsor Oversight of Statistical Programming Activities Agile sponsor oversight of a Contract Research Organization (CRO) for Statistical Programming involves a dynamic, collaborative, and flexible approach to monitoring and managing the CRO's work
How to get the most out of a CRO’s bid defense - Halloran Be sure to invite all sponsor study team members to the meeting It is important that everyone has an opportunity to ask questions of the CRO and voice their opinions That said, be selective about who from your senior management team is involved
A Sponsor’s Best Practice and Operating Principles to . . . - Springer A close and trustful collaboration between the statistical vendor and sponsor is crucial to ensure that the DMC receives timely and accurate data, and that the statistical vendor is well-equipped to support the DMC
ÿþP r o g r a m m i n g V a l i d a t i o n : P e r s p e c t i v e s a . . . Following section discusses some commonly used techniques for quality check and validation Depending on reporting requirements, and programming environment which sponsor or vendor has, the scope of each quality check and validation technique varies
Sponsor Oversight of CROs Data Management and . . . - PharmaSUG This paper highlights the Sponsor’s perspective for how to evaluate a CRO’s data management and statistical services, the key team players and their roles, how to manage study conduct to keep it on track, how to evaluate deliverables the sponsor receives for successful study conduct and documentation for a submission ready data package