CLINICAL DATA
MANAGEMENT
CLINICAL DATA
MANAGEMENT
At JCDC, we work with leading electronic data capture (EDC) technologies suited to your requirements and adapted to a decentralized/virtual trial approach.
We offer an end-to-end Clinical Data Management solution including:
Biostatistics services
At JCDC, we have a dedicated biostatistics department with an eminent biostatistician of international repute heading the department. Our bio statistical services can be customized to your individual needs as we have a wide experience in the design and analysis of clinical trials ranging from parallel group, cross-over and Bayesian designs to complex (population) pharmacokinetic- and dynamic evaluations, therapeutic equivalence testing and large variable sample size.
- Data Management Plan
- Paper CRF Designing
- CRF Annotation as per CDISC/ CDASH
- eCRF/Database Designing
- Edit Check Programming
- Pilot testing of CRFs
- CRF Completion Guidelines
- Database Go-live
- Project Team Training
- Data Review
- Query Management
- Medical Coding
- Project Specific Document Management
- SAE Reconciliation
- 100% Data Review
- Closure of Queries
- Final Reconciliation & Coding Activities
- Final Database Audit
- Database Lock
- Raw Data Extraction
- Analysis and Final Reporting
Agile EDC
Agile EDC
- Multiple EDC platforms which are 21 CFR Part 11 complaint
- Advanced tools including EPRO/ e Patients Diaries, Patients mobile interface and Randomization tools
- Integration with MedDRA and other Dictionaries
Trial
Platform
- Integrate various technologies, such as telemedicine, wearable devices, mobile apps, and electronic patient-reported outcomes (ePRO) systems.
- Enhance patient engagement, improve data collection efficiency, and potentially broaden the diversity of trial participants by reducing geographical limitations
Trial Master
File (eTMF)
- Digital repository that holds essential documents and records related to the management, conduct, and monitoring of clinical trials.
- Centralized and organized system for collecting, storing, and managing all documentation required to ensure compliance with regulatory standards and good clinical practices.
Informatics
solutions
- Access to 250M+ patient record
- Aims to make available real-time information on aggregated Patient Populations, across institutions & geographies
During the pandemic, the above platforms were deployed on several projects, consented over 2,500+ clinical trial participants using eConsent ; ePatient diary and maintaining eTMF documents; thus using efficient reliable , and trusted way of conducting virtual clinical trials by leveraging technology