The pharmacovigilance industry is moving towards unifying traditionally separate safety applications, such as reporting, submission gateways, signal analysis, pharmacovigilance content management and safety data management.
January 08, 2021
The current pharmacovigilance system architecture is fragmented with multiple applications, redundant safety data, and inefficient processes. With outsourcing, the complexity only increases. Companies that outsource pharmacovigilance activities, such as literature review, case processing, regulatory reporting, auditing, data analysis and risk management, rely on timely flow of information and want proper oversight data and processes. Increasingly, pharma companies are requesting direct access to the CRO or service provider’s safety system, or are requiring vendors to process data using the in-house pharmacovigilance application.
The pharmacovigilance industry is moving towards unifying traditionally separate safety applications, such as reporting, submission gateways, signal analysis, pharmacovigilance content management and safety data management. Organizations need to streamline pharmacovigilance workflows and provide better visibility and traceability of safety data.
Digitalized, fully integrated end-to-end processes are more efficient and enable repeatability and consistency. Safety teams and vendors can see up-to-date workflow management information. Data captured about processes are used as input into metrics to track and monitor operations. With greater transparency, all parties proactively address delays and ensure alignment.
Cloud pharmacovigilance applications are also flexible. CROs and service providers can set up standard or client-specific configuration and workflows to support different business models. CROs or service providers can own the safety application and perform all or specific safety activities, providing access to clients for visibility and collaboration, or easily access the client’s system to complete tasks and collaborate.
Join Kelly Traverso, VP Vault Strategy, North America, Veeva Systems; and Jennifer Kratz, Director, Safety Services, Clinlogix, in a live webinar on Wednesday, January 20, 2021 at 12pm EST to hear about how pharmaceutical companies and vendors are collaborating and simplifying processes with modern safety solutions.
For more information, or to register for this event, visit Improving Pharmacovigilance Outsourcing with Modern Technologies.
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