What to Know
An expert clinical data management (CDM) team can significantly reduce the time it takes to receive regulatory approval to market your drug. Obtaining the highest quality clinical data requires experience. How the data is gathered, analyzed, accessed, shared, and reviewed lay the foundation for excellence in clinical trials.
Your team will be with you from day one of clinical trials Phase 1 through the product life cycle. Your team must be prepared to meticulously adhere to quality standards of how your data is managed. There are design and annotation functions, data entry and validation, extraction of data, and access management tasks to be completed. Periodic reviews must also be performed to ensure ongoing compliance. I3 Infotek consultants can help your team ensure success.
How We Can Help
- Assess the clinical technology needs of your project to ensure efficient processes
- Help coordinate processes for all CDM tasks
- Provide computer platform and software expertise to expedite
- Oversee or support in-house teams for all CDM requirements
- Arrange individual or full CDM-team staffing