12.20.23
Thermo Fisher Scientific Inc. launched CorEvidence, a cloud-based data lake platform designed to optimize pharmacovigilance case processing and safety data management processes. The new platform aims to enhance CorEvitas clinical research registries offered by Thermo Fisher’s PPD clinical research business.
CorEvidence’s first application supports enhanced pharmacovigilance workflow and deliverable management. It is designed to handle multiple data sources and streamline coding, classification and reporting of adverse events and safety events of interest for committed post-authorization safety studies. According to the company, the platform supports a full range of pharmacovigilance deliverables with efficient, traceable, auditable, scalable, and compliant safety management for customer safety commitments using data collected through CorEvitas syndicated registries.
“I am excited to see us deliver fit-for-purpose, highly impactful solutions to some of our most challenging and complex pharmacovigilance business needs,” said Christine Barr, vice president of pharmacovigilance, CorEvitas. “We look forward to the positive impact this system will have on our customers and, most importantly, the well-being of the patients and our medical communities who depend on timely availability of real-world evidence and ongoing benefit/risk assessment activities to inform the safe use of pharmaceutical products.”
CorEvitas services include 12 registries, including nine autoimmune and inflammatory syndicated registries, and a data intelligence platform that builds and scales clinical registries across multiple therapeutic areas to gather structured patient clinical data spanning 400 investigator sites and over 100,000 patients followed longitudinally. The CorEvitas model is being leveraged to satisfy regulatory requirements for more than 15 long-term post-authorization safety studies across eight disease indications.
CorEvidence’s first application supports enhanced pharmacovigilance workflow and deliverable management. It is designed to handle multiple data sources and streamline coding, classification and reporting of adverse events and safety events of interest for committed post-authorization safety studies. According to the company, the platform supports a full range of pharmacovigilance deliverables with efficient, traceable, auditable, scalable, and compliant safety management for customer safety commitments using data collected through CorEvitas syndicated registries.
“I am excited to see us deliver fit-for-purpose, highly impactful solutions to some of our most challenging and complex pharmacovigilance business needs,” said Christine Barr, vice president of pharmacovigilance, CorEvitas. “We look forward to the positive impact this system will have on our customers and, most importantly, the well-being of the patients and our medical communities who depend on timely availability of real-world evidence and ongoing benefit/risk assessment activities to inform the safe use of pharmaceutical products.”
CorEvitas services include 12 registries, including nine autoimmune and inflammatory syndicated registries, and a data intelligence platform that builds and scales clinical registries across multiple therapeutic areas to gather structured patient clinical data spanning 400 investigator sites and over 100,000 patients followed longitudinally. The CorEvitas model is being leveraged to satisfy regulatory requirements for more than 15 long-term post-authorization safety studies across eight disease indications.