Clinical Data Management

Medical coding and writing


Indegene's medical coding team uses the MedDRA and WHO-DD dictionaries. We work extensively on medical coding applications such as RAVE Auto-Coder, TMS, DS Navigator, etc. The team has extensive experience in clinical data management systems such RAVE, OC TMS, Inform, and Clintrial.

Clinical research is inherited with medical writing. We work in close co-ordination with the biostatistical, project, and clinical data management teams. This ensures efficient and cost-effective deliveries with higher standards of clinical research.


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EDC build, support, and mid-study changes


Indegene's EDC study builders possess a unique combination of technology expertise, a deep understanding of clinical research, and rich industry experience. We have helped many sponsors with their biotechnology, pharmaceutical, and medical device studies, delivering optimized trial designs for years.

Indegene provides help desk support with expertise on e-learning, site activation and deactivation, user activation and deactivation, SAS on demand, data transfers, and PDF generations.


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Data analysis and data management


Indegene's CDM team has extensive experience with Phase 1-4 trials. We understand that the quality of data generated and how well it is analyzed could “make or break” the trial.

We work diligently with your team to ensure that your clinical trial data is of the highest quality – standardized, accurate, and complete, and is always managed with integrity, care, and precision.


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Integrations and IVR


Most pharmaceutical companies currently rely on a familiar line-up of information technology solutions to shorten clinical trial timelines, manage data, and contain costs. Clinical Data Management Systems (CDMS), Clinical Trial Management Systems (CTMS), EDC, Drug Supply Management Systems (DSMS), Safety, and IVRS are all now commonplace in clinical trials. However, these solutions would be more effective and efficient if they could work together. Indegene has the clinical experience and technical know-how to integrate the data, automate tasks, and aggregate data points so that these clinical systems can interoperate effectively.


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Clinical programming


We work with a range of interfaces, including SAS, R, Business Objects, and Spotfire, to provide metrics, datasets, and listings.


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Solutions consulting


We offer digital enablement of your Clinical Trial processes with vendor products and Indegene-developed products. Our experts help in assessment of needs, evaluation of options, road mapping, selection of solutions, implementation, integrations, and ROI measurement.


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