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:
- Case Report Form Designing (CRF / eCRF)
- Database Build and Designing
- Validation Programming (Simple / Advanced)
- User Acceptance Testing
- Data Capture
- Electronic Data Capture in EDC studies
- Double Data Entry in Paper studies
- Discrepancy Management
- Manual Review
- System Review
- Query Management
- Self Evident Corrections
- Tracking & Closing Queries
- SAE Reconciliation
- External Data Handling (Lab, Device Data etc.)
- Medical Coding
- MedDRA for Adverse Events
- WHO DD for Concomitant Medications
- Quality Review
- Initial, Ongoing, Final Quality Review
- Quality Review for Critical Parameters (100%)
- Quality Assurance
- Independent review for each document
- Involved at each stage of data processing
- Database lock activities
- Database close (Soft lock)
- Database lock (Hard lock)
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.