Clinical Trials are complex and even more so when multiple key deliverables are outsourced by Sponsors. It is critical for Sponsors to ensure regulatory compliance and patient safety and data integrity. The cost of non-compliance can be significant and anxiety-inducing to the most diligent clinical research professionals. Regulatory inspection findings can lead to increased scrutiny,…

The FDA guidance on quality risk management released in May (2023) offers principles and examples applicable to various pharmaceutical quality aspects. The principles of quality risk management in this guidance can be extended to clinical trial vendor risk management, covering different stages of a clinical trial. When applied to clinical trial vendor risk management, the…

Clinical trial vendor management requires a strategic approach, proactive thinking, and a deep understanding of vendor risk assessment at both the vendor and study levels. Two approaches to vendor risk assessment — vendor level and study level — serve to manage different types of risk. The assessments are complementary and critical to clinical trial delivery.…

We are excited to introduce Mayet, an innovative all-in-one solution in the world of clinical research outsourcing. Clinical research is a vital process that opens new avenues for treatment. However, it is fraught with complexities and challenges, particularly in the realm of vendor management. Fragmented systems, inefficient processes, lack of visibility, and increased risk are…