Specialized Safety and Regulatory Needs for Small and Medium Biopharma Companies

Applied Clinical Trials
December 2017
Author: Dr. Chitra Lele, Sciformix Corporation

Meeting today’s complex regulatory demands can be a challenge for even large pharmaceutical companies. But for the industry’s small-to-medium-sized enterprises (SMEs), it can seem impossible to keep updated on the requirements at all times and fulfill them to ensure compliance. That challenge is further compounded by increased financial constraints and pressures to get products to market as quickly as possible, with limited resources to move them through the pipeline.

Typically, SMEs outsource their clinical trials to full-service contract research organizations (CROs). However, as CROs are often selected for their niche patient recruitment capabilities, they may not always have the required level of skill across the drug development spectrum, in areas such as data management, statistical design and analysis, medical writing, safety, and regulatory submissions. Consider outsourcing to an external provider that specializes and has an understanding of the regulatory environment to help increase your chances of success. Consider outsourcing to an external provider that specializes and has an understanding of the safety and regulatory environment to help increase your chances of success.

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