Clinical Data and Information Management

Tribiosys has extensive experience in the clinical trials lifecycle, from design through submission of INDs, NDAs, PMAs, 510Ks and other relevant regulatory filings. Our team has knowledge and expertise in areas such as clinical data and trial management, clinical operations, safety and pharmacovigilance, and biostatistics. In addition, Tribiosys resources possess subject matter expertise in relevant standards (CDISC, DICOM, HL7 etc.), regulatory compliance (e-submissions, Computer System Validation, 21CFR Part 11/ HIPAA, ICH guidelines, Common Technical Document) and GCP/GMP. From a systems standpoint, the Tribiosys team has relevant experience with various EDC and paper-based systems, document and image management, CDMS/CTMS, statistical and safety systems, and associated technology experience in ETL, data warehousing and mining, dashboards and portals etc. Specifically, Tribiosys has helped its clients design and develop integrated data and information management architectures that enable them to streamline the capture and flow of data from investigator sites toregulatory submission, provide individual trial and cross-trial metrics, increase efficiency in designing case report forms and managing the aggregation/analysis of underlying data, and improve risk management via integrated safety/pharmacovigilance reporting. Such solutions have included integration with relevant products, and incorporation of standards and regulatory requirements to provide secure validated repository, analysis and reporting capabilities. The solutions are designed to enhance critical decision-making capabilities in the drug development and post-approval product life cycle by providing context-sensitive views of data to internal and external organizations (e.g., CROs).