Unifying Adverse Event Data with Cloud-based Integrations

Safety data from other functional areas are stored in separate systems and managed independently. Often complying with different data standards and business requirements, there are inefficiencies accessing or bringing relevant safety information from other systems such as clinical databases into pharmacovigilance applications. Streamlining receipt and processing of adverse event (AE) data with automation and better application integrations drives greater consistency and efficiency and improves data quality.

Custom integrations are challenging to maintain and require validation when the source system, integration, or safety application is updated. With more data sources, it is not scalable to manage multiple integrations. Companies are looking for new approaches to eliminate data silos and unify safety data.

Modern safety solutions make it easier to connect with other systems using productized integrations as well as accept files with standard data formats and provide APIs for custom integration. Innovation in cloud technologies are enabling clinical, safety, and other applications built on the same platform to seamlessly connect and exchange information – reducing manual overhead and accelerating processing times.

Join as we explore ways to streamline AE receipt and processing including:

• Real world use cases and benefits for integrating safety applications with clinical EDC, medical communication, and other systems
• Comparing different technical approaches to connecting systems
• Reviewing implementation considerations, risk, and lessons learned
• How cloud-based platforms are transforming approach to pharmacovigilance

Speakers

Mike Kruczek, Director, Vault Safety Strategy, Veeva Systems

Mike has 23 years of industry, software and consulting experience in the pharmaceutical, healthcare and manufacturing industries. For the last 15 years of his career, Mike has been focused on life sciences R&D and has worked with many of the top pharmaceutical and biotechnology companies on support of their PV process and system optimization efforts. During this time, Mike has helped his clients bridge the gap between business users and technologists to support them with business vision and strategy definition, operational roadmap development, system analysis and implementations, system integrations, business process analysis and operational improvement projects.

Mike joined Veeva Systems in February of 2020 to partner with the Vault Safety Strategy team to focus on growing the product’s capabilities and delivering on customer success goals.

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Svetlana Kolchinsky, Senior Director, Clinical Operations (US), Catalyst Clinical Research

Svetlana Kolchinsky, Senior Director, Clinical Operations (US), holds a dual Master’s Degree in Biotechnology and Business Administration from Johns Hopkins University.  Svetlana Kolchinsky is responsible for overseeing study management within Catalyst’s Clinical Operations team and brings experience from biotech, CRO and Core Lab side of the clinical research.  Svetlana has been a clinical research professional for more than 15 years and has been recognized for her team leadership in building successful clinical operations teams and the conduct and oversight of oncology clinical trials.

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