Pharmacovigilance Puzzle. The Complexities of Coordinating CROs, Contractors, and In-House Teams in Pharmacovigilance

Pharmacovigilance Puzzle

Post-marketing detection and reporting of adverse reactions to pharmaceuticals are crucial for patient safety. Therefore, regulatory authorities worldwide are becoming stricter in monitoring and post-marketing surveillance. Additionally, an adverse event can quickly garner negative attention globally, impacting the pharmaceutical company’s reputation and stock value. The market is witnessing increased products with growing complexity, accompanied by changes like medical drug usage. This trend leads to heightened demands for post-marketing monitoring, making pharmacovigilance increasingly crucial for pharmaceutical companies. As the volumes and diversity of medical drug usage continue to grow, the need for qualified and experienced pharmacovigilance professionals is higher than ever.

Consequently, many pharmaceutical companies turn to outsourcing and contractors to meet this demand. However, coordinating Contract Research Organizations (CROs), contractors, and internal pharmacovigilance teams poses challenges for many pharmaceutical companies. Let’s explore the possible solutions to these challenges together.

Are the options for Pharmacovigilance Teams internal, outsourced, or hybrid?

Pharmaceutical companies can employ an internal pharmacovigilance team, a full outsourcing/contractor model, or a hybrid. Each option has advantages and can be chosen based on the company’s needs and structure.

Building Close Bonds: The In-House model

Pharmacovigilance is an area where companies truly need dedicated and responsible individuals who identify with the company’s long-term success. The relationship between a pharmaceutical company and an in-house employee is close. Undoubtedly, an employee is more closely aligned with the long-term interests of the business, taking responsibility for both success and shortcomings. In-depth knowledge of the company’s products is the primary advantage of in-house specialists. Due to the heightened awareness of product safety, the company can always be confident in its production. But companies can make the work of their pharmacovigilance in-house specialists easier. Automation of pharmacovigilance processes helps specialists to pay more attention to clinical and scientific issues. For example, the DrugCard platform blog perfectly describes how modern technologies can improve and make it easier to perform routine tasks such as monitoring medical literature. Thus, the company retains complete control over critical pharmacovigilance processes.

Outsourcing Pharmacovigilance: The Role of CROs and Contractors

Many pharmaceutical companies turn to CROs or contractors to provide pharmacovigilance specialists. The company outsources all pharmacovigilance activities to an external service provider through a full outsourcing model. By collaborating with external experts, companies can avoid significant costs associated with establishing and maintaining an in-house pharmacovigilance department. Furthermore, this allows for optimizing resource allocation according to project needs. Therefore, the CRO/contractor model provides economic efficiency and flexibility. It also relieves the company from the need to develop internal processes and structures. It is common to find pharmacovigilance teams in companies where only one or two team members work directly, and CROs or contractors perform all other functions. However, continuous relationship management, including monitoring and establishing contract quality indicators, is necessary to maximize the benefits of CROs. Therefore, pharmaceutical companies must carefully choose a reliable CRO.

Embracing Flexibility: The Hybrid Model in Pharmacovigilance

The hybrid model involves outsourcing specific pharmacovigilance functions to a service provider. For example, a company may outsource only medical literature monitoring or database management while keeping other functions in-house. This model provides flexibility, allowing companies to adapt their outsourcing approach according to their needs. Additionally, pharmaceutical companies, CROs/contractors continually seek innovative technologies to enhance efficiency in cross-functional safety areas. For instance, they use cloud technologies that provide secure access to internal and external stakeholders from anywhere.

Striking the Right Balance: Internal Control and Outsourcing Benefits

Coordinating CROs, contractors, and in-house pharmacovigilance teams poses many challenges. While outsourcing to CROs and contractors ensures economic efficiency and flexibility, it demands vigilant relationship management. Pharmaceutical companies face the delicate task of striking a balance between internal control and the benefits of outsourcing, choosing between in-house expertise and external efficiency. For effective coordination, it is crucial to clearly define a specific scope of work, outlining the responsibilities and expectations of the pharmaceutical company and the outsourcing partner. In other words, it is necessary to determine which pharmacovigilance functions will be outsourced, the expected results, timelines, and key performance indicators. The hybrid model, involving outsourcing specific functions, provides adaptability. In this dynamic environment, where innovation in technology plays a crucial role, cloud technologies and automation emerge as critical tools to optimize communication and enhance the overall efficiency of pharmacovigilance activities.

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