Clinical trial set up – Clinical Monitoring – Post-Market Clinical Follow-up – Recent Projects
Delivering value with quality data
We have the expertise to manage data management activities related to clinical investigations designed to demonstrate clinical safety and performance of a medical device according to requirements stipulate in the ISO 14155:2020.
Clinical data management is a critical process in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures the collection, integration, and availability of data at appropriate quality and cost.
We use reliable Electronic Data Capture (EDC) platforms that can ensure the transparency, data integrity, and quality of your clinical data.
Our clinical data management team produces results that are verified at the source, delivering the transparency, integrity, accountability, speed, and accuracy you need.
- Data Project Management
- Development of CRFs
- Data Entry and Collection
- Investigator’s Brochure (IB)
- Data Review, Database Cleaning, Data Queries
- Development of Plans and Procedures
- Registration of Clinical Investigations on clinicaltrials.gov
