Metadata Repository Solutions
Metadata Repository (MDR) for standards have become crucial in the life science industry. In order to keep up with new iterations of data formatting standards and terminologies that support FDA and PMDA clinical data submission, it is crucial to have strong MDR at the foundation of your organization.
Clindata Insight has consultants with experience in helping several organizations implement MDR solutions and has provided MDR driven metadata process solution to many organizations. We have also been involved in the CDISC MDR SHARE team to develop and manage CDISC standards metadata in CDISC MDR. Clindata Insight has presented at industry meetings providing thoughts and insights on MDR implementation. Whether it is selecting your MDR foundation, system release, or "going live," we are here to support your MDR journey every step of the way.
Our MDR consulting service is built on two main processes.
MDR Selection Process
- Defining the business objectives of your MDR solution (regulatory compliance, metadata driven process, standards management & governance)
- Proof of concept
- MDR solutions evaluation (MDR technologies, business domains knowledge, services)
- MDR selection for your organization's needs
MDR Implementation Process
- System Development Life Cycle (Requirement, Design, Development, Validation and Deployment)
- MDR integration with other systems (e.g., SAS and EDC) through REST API
- Change Management
Build the foundation for your next important data compilation today and get started with Clindata Insight.