The regenerative medicine sector is at a remarkable moment. Transformative products are now on the market and accessible to greater numbers of patients every day. Dozens of additional therapies are in late stage studies. The regulatory and policy environment has evolved rapidly alongside the science, enabling a surge of incoming innovation.
The second part in this series discussed the entire RFP workflow from planning though selection of the best-fit CRO and included a documentation checklist and scorecard to lend practical support to sponsors. But now that you have selected a CRO and execution challenges are bubbling up, what can you do?
The ubiquitous nature of mobile devices means mining and monitoring social media channels and managing the challenges associated with them through technology, process management, and tactical outsourcing need to be considered standard operating procedure for clinical trials professionals and organizations.
When it comes to GCP audits and inspections, low-hanging fruit says a lot about the tree.
This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.
In part 1, types of procurement and strategic sourcing were discussed, showing how judicious planning and various selection criteria support a best fit outsourcing approach to your trial(s). So, what happens now? The selection committee will formalize the details using a request for proposal (RFP). The RFP is where you define and finalize the scope of services you are looking to outsource, and this holy grail of documents can make all the difference in a fair and equal comparison of vendors.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?
Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.
A range of factors — including small patient populations, complex manufacturing processes, and lack of specialized expertise — are positioned to both drive up costs and require new options for stakeholder engagement and risk sharing along the development pathway. New approaches in development are needed to support the next generation of novel drugs on the horizon.