Clinical data management is a critical part of the clinical research process. High-quality, reliable and statistically sound data management will reduce study duration and costs, validate the data collected, and expedite bringing your product to market.
At the core of our services are our data management systems Target e*CRF® (www.targethealth.com) and CleanDATA® – comprehensive web-based platforms for eDC and paper CRFs. Both systems are compliant with 21 CFR Part 11, supporting WHODrug and MedDRA coding. Our highly-trained data specialists have complete process knowledge that insures the quality standards of the data management process.
Our data management services include the following:
- CRF Design
- CRF Review
- Electronic data capture (EDC) using electronic case report forms (eCRFs)
- Paper CRFs
- Data management plan (DMP)
- Electronic randomization system
- Database design
- Data entry, including double data entry verification
- eSource electronic source documentation for EDC studies
- In-house data-monitoring for EDC studies
- Electronic informed consent form (eICF)
- Data validation, including edit checks and query generation
- Medical coding
- Quality assurance
- Database lock
- Clinical database auditing
TechnoSTAT’s data management team will work closely with your company and provide support for all stages of your clinical trial, from inception to completion.