Clinical Data Management
At Metis, our Clinical Data Management mission is to elevate the sponsor, site, and patient experiences through deliberate planning and collaborative consultation. Our team seeks to support our sponsors in achieving higher quality data and more dependable outcomes via the implementation of meticulous oversight and tried-and-true expertise.
The strategic inclusion of Clinical Data Management in our service offerings reflects our commitment to providing
Sponsors with top-tier support marked by flexibility and affordability. Metis consultants possess comprehensive expertise
in clinical research, spanning Biotech, Pharmaceuticals, and Medical Devices. With consultants who have over two
decades of industry experience, our primary objective is to swiftly and authentically align with our Sponsors’ unique
objectives. We seamlessly integrate into study teams, delivering immediate value and expertise.
Sponsor's Regulatory Obligations for Clinical Data Management
Core Data Management Services
Quality Data Review and Cleaning
Operational oversight by functional experts; responsible for ensuring quality data is achieved via quality processes.
- Oversight of traditional data management/data science activities
- Represent Data Management on behalf of the Sponsor
- Support fit-for-purpose vendor selection
- Contribute to the negotiation and finalization of vendor contracts and budgets
- Document review, input and alignment (DMPs, CCGs, DTAs, DRPs, etc.)
- Vendor oversight, ensuring quality and adherence to contracted responsibilities
- Audit conduct and support
- Gap analysis of existing controlled documentation
- Guide cross-functional review, input and interaction with clinical data
- Implement custom reporting to support comprehensive data review and data cleanliness
Quality Data Capture
Technological oversight; responsible for the implementation of fit-for-purpose data acquisition tools and associated processes.
- Certified builders
- Oversight of GCDMP, CDASH and CDISC-compliant data capture tools
- Support fit-for-purpose CDMS selection
- Design protocol-specific Case Report Form drafts for delivery to CRO
- Implement a CRF Global Library of Forms
- Develop data collection standards (form, check, instruction)
- Contribute to the negotiation and finalization of vendor contracts and budgets
- Initial database builds and interim database modifications
- URL Administration (Medidata Rave)
- Oversee the implementation of new platforms within an organization
- User Administration
- Vendor oversight, ensuring quality and adherence to contracted responsibilities