Thoroughly understanding statistics and data management, we manage your data, whether paper based or electronic (eCRF) to ensure quality and accuracy. The data management process, like a clinical trial, begins with the end in mind. We assist you to generate high-quality, reliable, and statistically sound data thereby reducing time from development to submission.
Data management including database setup and data entry are performed under strict quality assurance standard operating procedures and are 21 CFR part 11 and GCP compliant.
Through strategic collaboration with two leading eCRF software providers we can set you up with an optimal EDC solution for your needs and budget.
We ensure that all procedures are properly in place. Our services include:
- Case Report Form (CRF) design and review
- CRF annotation
- EDC and Paper Trial Set-Up & Management
- Data Management Plan (DMP) development
- Database Build & Design
- Data-entry (only for paper based studies)
- Data validation (Safety Data Management & Reconciliation)
- Discrepancy and query management
- Medical coding
- Import, Integration, and Cleaning of External Data (Lab, ECG, PK, Diary, etc.)
- Development of Custom Periodic Reports – part of risk based monitoring