Safety and Regulatory Solutions to Address the Needs of Small and Medium Biopharmaceutical Companies

International Pharmaceutical Industry
July 2017
Author: Dr. Chitra Lele, Sciformix Corporation

Clinical trials are typically outsourced to full service clinical research organisations (CROs) and many SMEs select them based on a CRO’s ability to recruit patients in certain geographies and therapeutic areas. However, some CROs do not have the required level of speciality in other areas, particularly in data management, statistical design and analysis, medical writing and regulatory submissions.

Another challenge is that trials may be outsourced to several CROs, resulting in drug safety and pharmacovigilance (PV) data, along with the technology infrastructure that supports it, being housed at multiple CROs. This often leads to safety data being reviewed and reported separately, rather than being reviewed and analysed at the aggregate (product) level, and data are often collected in different systems. This can put organisations at risk when filing a new drug application, as they will not be able to review and analyse consolidated data to proactively identify and manage safety concerns.

Post-marketing activities, including end-to-end safety and risk management for approved products can be very resource intensive. Many SMEs do not have the internal capabilities to manage these activities as it diverts finances and manpower away from new product development and marketing. Therefore, many such organisations do not have an established safety group and either the clinical development or regulatory groups are responsible for safety activities, leading to lack of focus on critical PV activities. Clinical and regulatory activities in the post-approval phase for registration in different markets and evaluation of safety, efficacy and effectiveness for sub-groups and for other indications can also be quite resource-intensive.

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