Data Management
Data Management
Clinical trial is intended to find answers to the research question by means of generating data for proving or disproving a hypothesis. The quality of data generated plays an important role in the outcome of the study. Our data management solutions are designed considering the above critical points.
EDC Management:-
Clinical data management is one of the key aspects of clinical trials, as statistical inferences are derived from EDC data; which decides the outcome of a particular trial. Therefore, it is imperative that EDC data is accurate, reliable, complete and statistically sound. Our team is competent in EDC systems, with several years of rich experience in Clinical Data Management (CDM). We can in-source end to end CDM services, including:
- eCRF Designing
- Database Build
- UAT and Validation
- Data Entry
- Discrepancy Management
- Review and lock of eCRFs
- External data reconciliation
- Database cleaning and lock
Paper TMF (Trial Master File) Management:-
TMFs are a collection of documents and other artifacts that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Our team is equipped in managing and archiving paper TMF documents as deemed necessary by the country regulations and Sponsor requirements.
eTMF Management:-
In order to comply with regulatory requirements, every organization involved in clinical trials must maintain and store data related to clinical trials. This data should be able to reproduce the trial at any given point in time. Our competent team has rich experience in managing eTMF for small to large studies with huge data. We provide services right from scanning paper documents, to embedding them under the appropriate artifact, to ensuring all relevant documents are classified and uploaded on the designated eTMF system. We provide end to end eTMF solutions to our clients.