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Data Management
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DATA MANAGEMENT
The Clinical Data Management Department is crucial in ensuring the accuracy, integrity, and compliance of clinical trial data. By employing standardized processes, robust quality control measures, and cutting-edge technologies, this department contributes significantly to the successful execution of clinical research studies, ultimately advancing the development of new and innovative healthcare solutions. Our Data Management Department provides customers with centralized, coordinated services for local and international studies. We handle all phases of clinical studies across the full spectrum of therapeutic areas. Team develops flexible and customized data management plans to accommodate each study specific needs. We also offer customized reports to customers at timely and periodical intervals to get the complete status of the study at any given point.
Our Team comprises experienced data managers who are well-trained in ICH-GCP and GCDMP with work exposure across the therapeutic areas having expertise in handling clinical trial data from Phase-I to Phase-IV studies for Submission to national and international regulatory bodies. Our Data Management Software is 21 CFR Part 11 compliant and has the capability to deliver extensive Clinical Data Management projects.
Our data management team can manage multi-center, multi-country studies in both electronic and paper based format.
We are specialized in managing the following Data Management activities:
- Electronic Data Integration
- SAE Reconciliation
- Design Safety Database
- Customised Data Listings
- Double Data Entry (paper CRF)
- Coding in MedDRA and WHO DD
- Data Management Plan
- Query Resolution and Database lock
- Data Entry, Verification and Validation
- Paper CRF/eCRF Development and Database Design