CLINICAL DATA MANAGEMENT

Genpro offers an experienced team of clinical data managers and clinical data coordinators who comes with a life science background. They are trained in ICH/GCP as well as CFR PART 11 guidelines. Genpro has extensive experience in various EDC tools and provides EDC setup services to different phases of clinical trials. As part of these services, we have acted as the data management centre and supervised the Data Collection, Query Management, Data Cleaning and Database lock. Genpro prepares a comprehensive data management plan (DMP) which is a road map to handle the data under foreseeable circumstances and describes all the CDM activities to be followed in the trial. We have also been part of several data monitoring committees which oversaw the process with various sponsors.

Work Flow

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 make sure that the data is complete, accurate, and compliant with the study protocol.

DATA VISUALISATION

Interim 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 end points 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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