Data Management

In the healthcare industry, clinical trials and clinical research are conducted to compile data regarding new drugs or devices which will ultimately lead to better medical treatment. The MHICC Clinical Data Management team, is proud to be part of this process and is dedicated to creating a database for your study that contains data of the highest quality, which will prove the foundation of your successful results. We have been providing data management services for more than 20 years and most of our team members joined the MHICC with many years of Pharmaceutical and/or CRO Industry experience across different therapeutic areas. Looking to the future, our vision is to embrace and contribute to the evolution of data sciences to enable and accompany decentralized and risk-based clinical trials environments and patient-driven data frameworks.

A well developed and streamlined database is the cornerstone of a successful study. Employing modern technologies and software, we design eCRFs for phase II-IV clinical trials, observational studies and registries and believe that a strong cross-functional relationship is essential between the Data Management (DM), Clinical, Medical and Biometrics teams to ensure easy data collection and statistical output.

We can perform all aspects of clinical data management for your organization:

• EDC database build and validation (CDASH)
• EDC database online integration with IWRS and other external data sources
• Data review plan, edit check programming, testing, and validation
• Data quality review for inconsistencies, trends, and outliers
• Query management
• Medical coding (MedDRA and WHODrug)
• SAE and central laboratory and imaging data reconciliation
• Real-time metric reports
• Risk-based monitoring support