A key challenge for small and medium-sized enterprises (SMEs) is the optimal utilization of their limited resources as they move their product pipeline through clinical development to product launch and marketing their approved products. This is further intensified as both clinical trials and post-marketing activities continue to grow in complexity and scope due to stringent regulatory pressures, increased patient involvement, and wider global reach.
- Within the clinical trial environment, a comprehensive understanding of the safety profile of a product requires evaluation of safety data across all completed and ongoing clinical trials, as well as of any other drugs in the same class.
- On the technology side, implementing validated, regulatory-compliant pharmacovigilance (PV) systems requires significant investment in a robust quality management system (QMS) and the right expertise to select, implement and support the right solutions.
- On the PV operations side, associated responsibilities such as aggregate safety reporting, benefit-risk evaluation, signal detection and management and development of risk management plans are becoming more complex and resource-intensive.
The most common pitfalls in safety monitoring during the product lifecycle include failure to:
- Integrate multiple safety databases, required for comprehensive safety review
- Develop robust written SOPs and work instructions for safety management
- Analyze, review and document all pertinent clinical safety data (adverse events and events of interest, laboratory data and other investigations)
- Review and update Investigator’s Brochure (IB) on a timely basis
- Coordinate case submissions to regulators, ethics committees and investigator sites across multiple clinical studies, as required and within timelines
- Submit DSUR/IND Annual Reports per schedule and applicable regulations
- Ensure audit and inspection readiness at all times
Establishing a comprehensive PV organization in-house can be challenging for SMEs. This is because dedicated and experienced professionals are required to manage PV operations as well as the enabling technology architecture/infrastructure, both of which can require significant investment.
Embracing New Strategies:
Small to medium sized organizations can beneﬁt by embracing newer strategies to manage their responsibilities during clinical development and in the post-approval phase. Using niche scientific process organizations (SPOs) and functional service providers (FSPs) that specialize in PV and the associated supporting technologies, as well as providing broader expertise in areas such as statistical design and analysis, clinical data management and offerings that optimize patient recruitment and manage clinical trial conduct, can help ensure the best strategy is implemented.
In the area of safety and risk management, PV-in-a-Box (see figure below) is a holistic customer-centric approach that brings together safety, technology and advisory services towards the provision of a complete end-to-end safety solution. This integrated and ﬂexible shared services outsourcing model ensures regulatory compliance, quality data, product safety, lower risk, cost savings and allows sponsors to focus on what they do best – develop and deliver new medicines to the market.
To learn more about Safety & Regulatory Solutions for Small and Medium Sized Life Science Organizations. Click here.