Clinical Data Management | Clinical Data Management CRO | Clinical Data Management Services

CLINICAL DATA MANAGEMENT

DATA MANAGEMENT PLAN Comprehensive data management plan which explains all the components of the Data Management process. We deliver a comprehensive data management plan (DMP) which explains all the components of the Data Management process starting from the ‘CRF Design’ to the ‘Database Lock’ on a clean and error free database.

DISCREPANCY MANAGEMENT Query Resolution compliant to the study protocol. All manual or auto-generated queries/ discrepancies need to responded to and resolved by corresponding site personnels. Thus, the discrepancy management makes sure that the data is complete, accurate, and compliant with the study protocol.

DATA VISUALISATION I​ nterim monitoring of trial through data visualization dashboards. Clinical Data Visualisation and constant monitoring of data forms an integral part of clinical data management these days. Genpro used visualisation tools like TIBCO Spotfire, Tableau and Qlikview to provide visualisation services to our customers.

DATA MONITORING COMMITTEES Complete data monitoring package and DMC representations. We offer a complete data monitoring package which involves, organisation, set up, unblinding, production of data packages, database backup and recovery and interim data analysis. We have experience organising data monitoring committees worldwide.

DATA VALIDATION Ensure the quality and integrity of data through effective validation. The two step process, Data Validation and Cleaning ensures the quality and integrity of the data which is provided for analysis. The validation checks created for all study endpoints helps to identify the inconsistencies and potential errors.

CRF DESIGN Clear and Concise CRF which capture study data to its fullest. Quality of the data relies on the quality of data collection instrument- (CRF). We make sure that the questions and instructions provided in the CRF is clear and concise

​DATABASE LOCK

Standard pre-lock checklists will be executed prior to database lock. Once the discrepancy management activities are over, based on a pre-lock checklist the final database lock is carried out. Final data extraction is carried out and provided for data analysis.

EDC SETUP EDC experience across multiple platforms, therapeutic areas and study phases Complete data monitoring package and DMC representations. Our EDC Setup and Development service includes the design of Case Report Forms, CRF completion guidelines , Trial database setup, Validation checks, data extraction,and the database lock on the clean database.

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Contact Us : ​ Phone no : ​+91.471.2700151 / 2700152 Email : info@genproresearch.com