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:
- Paper and eCRF Designing
- CRF Annotation as per CDISC/ CDASH
- CRF Build
- Edit Check programming
- Pilot testing of CRFs
- CRF Completion guidelines, DM Plan Database design
- Database Go-live
- Project Team training
- Data review
- Query management
- Clinical data coding
- Project specific document management
- SAE reconciliation
- 100% Data Review,
- Closure of Queries
- Reconciliation &
- Coding activities
- Final dbase closure
- Database lock
- Analysis and Final Reporting
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.
Jehangir Hospital, along with its research arm Jehangir Clinical Development Centre (JCDC) has a strategic tie up with Basel, Switzerland based Clinerion. We are the first hospital in India to bring its patients access to international clinical trials by joining Clinerion’s Patient Network Explorer (PNEx) platform. Patients of JCDC gain visibility on Patient Network Explorer for matching to international trials run by sponsors around the world.
JCDC has established a strategic alliance with a virtual clinical trial platform provider. Consilx. The platform called LifeLedger™ is a patient focussed platform for Patient enrollment, eConsent, Patient data capture, and Clinical supplies tracking in a single application. With this JCDC can offer its clients efficient, reliable, & trusted ways of conducting virtual clinical trials by leveraging technology
JCDC works with Clindox which has a user friendly and agile EDC platform called CRFWeb CRFWEB provides an end-to-end solution to design a study, collect data, manage and validate that data and then report on the outcomes. Remote users can access mobile technology, collating data while with a subject and recording it in real time directly to their database.
Agile EDC
and Agile
EDC
- End to End EDC
Solution which is 21
CFR part 11 compliant - Advanced tools
including EPRO/e
Patient Diaries, Patient
mobile interface and
Randomization tools - Integration with
MedDRA and othe dictionaries
Clinical Trial
Platform
- Consilx which has a patient focuse platform called Life Ledger
- Patient Enrollment, eConsent Patient Data capture, and Clinical supplies can be tracked in single application
- Life Ledger has the
capabilities of e Source and
eCRF within a single
platform
Trial Master
File
- Use of Veeva Vault which is Online repository of Site / Trial Master File (SMF / TMF ) documents.
- Veeva Vault helps
Manage documents in
real-time to bring in
efficiencies of remote
monitoring, inspection ,
readiness, increased
visibility and oversight ,
and improved
collaboration
Informatics
solutions
- India partner of US
Headquartertered TriNetX - Access to 250M+ patient
record the partnership
aims to make available
real-time information on
aggregated patient
populations , accross
institutions &
geographies
During the pandamic , 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