Clinical Data Management

Karmic offers comprehensive Clinical Data Management (CDM) services in adherence to regulatory and project specific requirements. Our CDM team comprises highly skilled and experienced team members, who have worked with Phase I-IV trials and complex therapeutic areas. The CDM team works with the objective to deliver high quality data on time to achieve client’s expectations and to advance the process of regulatory submission.

Our highly experienced team consistently achieves successful database locks with the help of 21 CFR part 11 compliant DM solutions, robust documentation system, Quality Audits at each stage of data processing and round-the-clock user support.

We can deliver high quality data management services for:

The Clinical Data Management team at Karmic has extensive experience in paper as well as in EDC study across all therapeutic areas namely, Oncology, Dermatology, Ophthalmology, Analgesic, Gastroenterology, Reproductive System, Hypertension and Endocrinology and others.

We have expert CRF designers who effectively design the CRF in very user-friendly manner, which minimizes errors. We have experienced data entry associates with in-depth knowledge in clinical terminology. We have dedicated manpower for discrepancy management of each trial, which enables us to make Database Lock (DBL) in very less time. We have medical and concomitant coding specialist with rich experience across all therapeutic areas. Our Quality assurance group is involved in all the data management procedures to effectively ensure the regulatory compliance.

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