Clinical Data Management System
Our clinical data management system is a powerful tool for the effective and flexible management of your project. Our data management system is adjusted to accept new projects with different needs. We provide online access to the data in various formats, enabling you to view the data at your convenience. Data can be exported as SAS datasets or into a format of your design and choice.
Case Report Form Design
We design for you CRF according to the study protocol. Our CRF designs assure that the data recorded on them support your protocol objectives.
Database Design and Development
The clinical database is developed from your protocol and CRFs for precise data storage and reporting. We document the database design and fully validate the database to guarantee its functionality and stability. Our data conversion programs are designed to your specifications for the final database transfer, and we provide converted datasets for interim review.
Double Data Entry and Reconciliation
Independent double data entry and reconciliation is one of the most reliable methods of data capture and minimizes database errors. Two different operators enter the data independently, while the data is blinded for the second operator. The system checks for mismatched between the databases. When completing the 2nd entry and resolving all discrepancies, the data is transferred to the final files. We continue the comparison process until all data errors are resolved.
We employ a variety of tools to guarantee the quality of your data including verification checks, data reviews, and quality control audits. Based upon your protocol and specific requirements we develop and validate verification checks. Our verification checks include logic, range, across form, and consistency checks of the clinical data. Based on the verification checks, the system produces queries which are sent to the CRO for correction or verification. Periodically, we conduct quality control audits to assure database integrity and adherence to medical and data review conventions.
MediStat uses data dictionaries to standardize variable attributes. Diagnoses, adverse events and indications are classified using MedDRA dictionary or ICD9 code, as necessary. Medications are classified using the international medications dictionary CO-STAR. The classifications are performed for us by an experienced physician who is trained for working with the above dictionaries.