Addressing the safety and risk management needs of small and medium sized businesses

The pharmaceutical industry is constantly evolving as global regulations become more stringent and the costs associated with drug development continue to rise. Furthermore, biopharmaceutical organizations are faced with continued pressure to make cost-saving measures.

For small to medium sized enterprises (SMEs), the ability to appropriately scale their limited internal resources, remain compliant to applicable regulations and continue to deliver new products to the market as quickly as possible is an additional burden. Oftentimes, safety and pharmacovigilance (PV) operations, along with its underlying IT infrastructure, are difficult to prioritize and support internally As a result, these organizations are evaluating their strategies and looking for quality and cost-effective business models to innovate and transform their safety operations and overcome their impending challenges.

Many companies are choosing to explore cloud technologies and they offer benefits of both scalability and business flexibility to enable them to meet their fluctuating market needs. It also helps them to transform themselves by focus on more becoming more innovative work while and reducing IT infrastructure costs. However, the pharmaceutical industry can be slow to adopt new technologies, taking time to thoroughly assess the risks, cost of adoption, advantages and disadvantages. It’s no different with the latest technology trend – Cloud Computing which is much more mature in other industries.

Challenges for SMEs

SMEs are faced by a number of challenges as they have to determine how to utilize their limited resources to effectively move new molecules through the clinical development pipeline to the marketing approval and launch of their approved product(s).

During clinical trials safety-related activities, and the technology infrastructure that supports them, are typically outsourced to multiple CROs as they are coupled to the overall management of each study. This often leads to safety data for a single product being collected, reported and housed in disparate systems, resulting in non-integrated and non-standardized data. This puts the marketing authorization holder (MAH) at risk at the time of filing of a new drug application when it’s important to review and analyze consolidated data, define the initial product label, and proactively identify and manage safety concerns.

For many SMEs managing safety and risk operations internally can be resource-intense and not scalable, diverting extensive effort and financial spend away from product development and eventually post-marketing support when additional regulatory and commercial costs are necessary. Often, such organizations do not have distinct internal safety groups and either the clinical development or regulatory teams are responsible for safety activities as well, leading to lack of focus on critical PV activities.

Common PV pitfalls during the product lifecycle

Since many smaller organizations do not have a distinct safety group they are often unable to prioritize important safety and regulatory activities that are part of the product lifecycle (as depicted in Figure 1). Lack of PV expertise and suboptimal standard operating practices can lead to regulatory non-compliance and higher costs through missed work, rework or low quality output