It can be challenging not only for small-to-medium-sized pharmaceutical companies (SMEs) to follow and comply the updated regulatory requirements but for large enterprises as well. SMEs are under pressure because they have restricted financial resources and they have to get the drug to the market as soon as possible. It is a common practice that small biotechnology companies develop medicines for rare conditions and focus on very specific target populations.
For that reason, SMEs usually involve contract research organizations (CROs) to conduct all steps of clinical trials. What’s more, SME sometimes outsource several CROs located in different places to conduct clinical studies. This leads to the fact that safety data may be analyzed, submitted and revised separately which can influence the final results and conclusions. All these aspects put SMEs at risk when they submit new drug applications (NDAs) to get the approval. That’s why it is crucial to review and analyze the combined data first.
This implies that SMEs should outsource end-to-end regulatory and safety and risk management organizations or single CRO service with experienced specialists in this area, otherwise, the companies may not ensure the proper evaluation of safety and efficacy of their products during the post-approval phase.
Employing a reliable pharmacovigilance functional service provider (FSPs) to outsource safety responsibilities during clinical trials and the postmarketing stage is a good solution to assure best-practice operations.