Vendor management in trials still a major challenge for smaller sponsors
Smaller drug makers that struggle to manage service providers during clinical trials run the risk of non-compliance according to new research.
The study – published in the journal Drug Discovery Today – looked at the management challenges small drug makers face when it comes to running trials using the authors own company – Finland-based drug maker Faron Pharmaceuticals – as a case study.
And the key finding is that vendor management is both a major challenge and a significant regulatory risk.
The authors write “Many small pharmaceutical companies find that they lack the resources, knowledge, and expertise of the regulatory landscape for adequate vendor management in clinical trials, making the organization vulnerable.
“Recent research suggests that some pharmaceutical companies have found themselves out of compliance with ICH, FDA or EMA guidelines.”
QTLs
They also set out to assess whether Faron’s approach to vendor management – which uses specified quality tolerance limits (QTL) as well as KPIs and SOPs - is effective in terms of regulatory compliance.
According to the authors “Faron Pharmaceuticals conducted a process improvement activity at the beginning of 2022 to improve the vendor selection, oversight, and evaluation of their clinical trial partners.
And the findings are positive for both Faron and potentially for other small drug makers if they adopt similar management practices.
“The results of this case study indicate that Faron Pharmaceuticals’ processes are regulatory compliant, suggesting that QTLs, KPIs, SOPs and communication plans are effective vendor oversight mechanisms for small pharmaceutical companies to utilize.”
KPIs and SOPs are well established. However, quality tolerance limits are less widely used. Put simply, QTLs are a level, threshold, or value associated with a parameter that is critical to quality which, in the context of a trial services vendor or provider, covers the third party’s ability to meet its contractual obligations.
The research suggests that setting QTLs and involving vendors in the process provides a very effective mechanism that ensures research goals and met and compliance with applicable regulations in maintained.
Publication of the study comes just a few weeks after the US Food and Drug Administration (FDA) gave Faron feedback and recommendations for the future development of bexmarilimab as a monotherapy in multiple solid tumors.
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