By Charles T. Saldarini, CEO, Sentrx
With the biopharmaceutical industry’s increasing emphasis on safety, global adverse event (AE) management is receiving renewed attention. The challenge is balancing high quality AE processing and reporting against unpredictable volumes while meeting new needs in signaling, surveillance, and risk management.
In this highly regulated field, exceptional expertise is required to create effective and efficient outsourced pharmacovigilance programs. Successful solutions are customized to your company’s needs, seamlessly integrated into an existing structure, and scaled to changing circumstances. Through outsourcing, companies can develop an optimal ratio of fixed to variable resources across the pharmacovigilance spectrum, allowing allocation of internal resources to critical, strategic operations.
Intensifying global regulatory requirements are a challenge to sustaining a continuously improving program that integrates safety operations with clinical, epidemiological, biostatistical, and information technology skills. A provider whose core skill is safety instills confidence in your team through credentialed experts who can develop, implement, or maintain anything from a full-service safety program to a specific needs project. Even organizations with extensive internal safety capabilities may benefit from reallocating resources to add flexibility and stimulate new thinking.
Customized solutions benefit your company the most. Seek a service provider with proven experience and expertise in planning and executing strategies matching your specifications, personnel, and technology. Consider the provider’s fit with your team, flexibility, and willingness to accommodate your needs. Be certain to establish expert-to-expert opportunities between your team and the provider to create early opportunities for customization and realignment. If your partner has the aforementioned qualities, your company’s individual requirements will drive integration.
What Needs To Be Integrated
Effective pharmacovigilance outsourcing integrates people, processes, and technologies into established functions, departments, workflows, and processes to leverage existing safety assets. Expert safety providers use technology to enhance the visibility and management of outsourced functions, maximizing sponsor flexibility through strong control over essential processes and data. When properly utilized and deployed, outsourced expertise contributes insight into the work itself, enhancing quality and compliance, while producing internal reporting that global safety teams will value.
Scalability of staff and technology must also be considered. While many outsource providers recommend capacity utilization resource models (i.e. increasing resources to fill pre-existing facilities), a better alternative is a real-time management model, which accounts for fluctuating AE volume. Using a flex resource approach with global deployment and sponsor-specific resource designations provides a customized, integrated safety team. It embeds the ability to meet demand resulting from any circumstance without increasing headcount, providing savings for sponsors. Further scaling can be achieved by externally managing connectivity, security, compliance, and validation of technology.
When seeking an outsourcing partner, you’ll want to expand your long-term horizon and select one with expertise and experience to architect solutions that are equivalent or superior to internal standards. A provider that truly understands your company’s long-term goals and objectives will customize solutions to fit your current and future needs, integrate solutions to ensure an effective partnership with satisfactory levels of control, and be scalable to meet the ebb and flow of your business. By selecting such a “full-service” partner, you will minimize your oversight of resources while you maximize the company’s knowledge of your product’s safety profile, helping you integrate safety into your commercial planning and allowing greater influence with regulators, payers, and ultimately patients and prescribers. Ultimately, this will protect both the public and your company.