or the more than 1 billion drugs provided or prescribed to patients in the US, what if an adverse event is missed or not reported quickly? That question looms heavily for biotech companies that outsource pharmacovigilance, regardless of whether the company is clinical-stage or commercial-stage.

#1: Improve outcomes with an advanced oversight model

When outsourcing, growing companies expect CROs to care for end-to-end safety activities. This means that CROs will own the people, processes, and technology while ensuring efficiency and compliance. However, sponsors are still responsible for the safety of their products. Relying on data transfers, manual reports, and emails for oversight can lead to missed data, delays, and errors.

A technology infrastructure that allows seamless collaboration for case processing, reporting, and submissions can deliver better oversight and mitigate risks. If biotechnology companies can access real-time data, they can dig deeper into delays and keep up with key milestones. For a growing company, it is vital to drive efficiency in safety monitoring and reporting, and to reduce risk. Maintaining ownership and control of safety data can help streamline oversight and improve how biotechnology companies work with their pharmacovigilance partners.

#2 Reduce risk by owning safety data

Imagine facing a regulatory inspection under these circumstances. Companies need seamless collaboration across their partner ecosystem to prepare for and meet regulatory requirements. CROs can deliver much-needed services to speed up processes, but not having immediate access to safety data can be a considerable risk. When outsourcing, many biotechnology companies don’t consider the significant impact a lack of data access, visibility, and ownership can have on their safety operations and ability to pass regulatory inspections.

“Gaining access to safety data requires a formal request, permission, and payment for a data transfer or custom report,” says Tawny Landtiser, a pharmacovigilance director and former ICU nurse with 10 years of drug safety experience. “If you have to pay a data transfer fee, you don’t own your data.”

What if biotechnology companies could own their safety data and still outsource to CROs? This is possible by changing the mindset around outsourcing, adopting new ways of working, and bringing in cloud technology that augments collaboration and speed.

Traditionally, owning a safety system wasn’t an option for biotechnology companies for several reasons: the small size of their pharmacovigilance teams, the cost of applications designed for larger companies, and a lack of alternative solutions beyond basic tools such as Excel. But with modern safety technologies, designed to be more flexible and agile, even smaller companies can own their safety system. This allows companies to maintain their data and provide partner access to capture additional information, process cases, or submit reports. A cloud-based safety solution can deliver speed and transparency, enabling the flexibility to work with multiple CROs based on business needs.

#3: Enable greater speed and agility with modern technologies

• Lay the foundation to own safety data. For biotechnology companies just starting to build a pharmacovigilance function, an in-house safety system that enables seamless vendor collaboration is key, since it allows sponsors and CROs to access and work with the same data and documents. For example, one biotechnology company can author and approve safety information and then make it immediately available to its partners. This approach provides flexibility and speed without requiring data migration, and risking loss of information, from the CRO. It also ensures real-time transparency without any additional overhead costs associated with traditional CRO safety reports or data transfers.
• Evaluate technology that allows for role-based access. In-house applications that empower biotechnology companies to own data are a significant step forward. However, they should also provide access for third-party partners to review data or manage processes. Enabling partners to log in and execute in one place delivers efficiencies while improving data quality.
• Select pre-validated tools. Validating a new system can overburden a small safety team. Pre-validated solutions can speed up implementation and provide a competitive advantage. Consider whether the system has built-in best practices, reports, and workflows. If it does, much of the upfront work for implementation and validation is off the to-do list.
• Ensure alignment with the CRO’s model. Even in the context of a strong technology foundation, consider the CRO’s outsourcing model and whether they are flexible to work in the same system as the biotech sponsor. A biotechnology company can be back at square one, even with a modern tool, if the partner only works within their own internal systems.
• Drive cross-functional process efficiencies. Many safety processes span across departments. For example, Clinical feeds adverse event information to Safety for analysis, and then from Safety to Regulatory for Investigational New Drug (IND) applications reporting. Another example is how Quality feeds complaints information to Safety for review and provides data to Regulatory to submit reports to regulators.

Integrating safety systems across these functions allows for automated document and data exchange, improved visibility, and better team cooperation and alignment. Integration might not be suitable for everyone, but if a lot of data is coming from other areas, such as Clinical and Quality, it can be beneficial to streamline information exchange to address adverse events faster.

Changing the Approach Behind Safety Outsourcing

Consider a model that provides centralized oversight and data ownership while supporting collaboration across partners and teams. Designing an outsourcing strategy with these critical factors in mind helps implement streamlined practices. With faster identification of adverse events and trends, safety teams can mitigate issues quickly for the benefit of patients.