Biostatistics, clinical data management and programming are all critical elements of the clinical trial process and have evolved in response to the ever-increasing demand from companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation. To deliver speedy and high quality results, clinical trials need to be designed smartly and analyzed accurately, in adherence to quality standards and practices.
Our data managers have significant experience in database building, clinical monitoring and data management activities using multiple EDC systems like Oracle Clinical, InForm, Rave and Open Clinica, across all phases and therapeutic areas for multiple studies and registries. Additionally, we have a highly customizable, EDC enabled, 21 CFR compliant database for post-approval and epidemiological studies.
This expertise, combined with our clinical domain knowledge, is leveraged to provide a wide range of services in coordination with the statisticians, medical writers, reviewers and programmers, which include:
Data management services
- CRF (case report form) and database design
- Data capture
- Data validation and discrepancy management
- Medical coding
- Serious adverse event reconciliation
Read more about our comprehensive Data Management, Programming and Statistics services by completing the brief form below.