Improving Pharmacovigilance Outsourcing with Modern Technologies

Oversight and compliance are challenging when drug development processes are outsourced. Pharma companies, CROs, and service providers are looking for innovative technologies that can increase transparency for all stakeholders and drive greater efficiencies across cross-functional areas within safety.

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. Leveraging cloud technologies, modern solutions easily allow secure access to internal and external parties, from anywhere, at any time.

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. With greater transparency and efficiency, CROs and service providers are giving clients a higher level of service.

Join this webinar to hear about how pharmaceutical companies and vendors are collaborating and simplifying processes with modern safety solutions.

Speakers

Kelly Traverso, VP Vault Strategy, North America, Veeva Systems

Kelly has over 18 years of industry and consulting experience supporting biotech and pharmaceutical companies. At Veeva, she is responsible for safety strategy and customer success for North America, and has extensive knowledge and experience with the US FDA, and EMA safety and quality regulations. Kelly has applied specialized knowledge of regulatory and compliance to business processes across the life sciences. She has developed strategies, designed and redesigned processes, supported technology implementations and defined governance across the spectrum of pharmacovigilance activities. Her in-depth industry knowledge helps clients stay aligned with industry-leading practices and remain competitive in the marketplace.

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Jennifer Kratz, Director, Safety Services, Clinlogix

Jennifer Kratz is a highly experienced pharmacovigilance and medical device vigilance professional with over 16 years of global clinical research experience in pre-and post-market product safety. Her skills and experience include safety database design and development, risk management, supplier management, suspect product recall management, global clinical trial project management, case report form development, clinical trial protocol development, clinical evaluation reports, standard operating procedure development, quality auditing, regulatory inspection readiness, root cause analysis, Clinical Events Committee coordination, and Data Safety Monitoring Board coordination.

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