Data management/IT

Data management is one of our key strengths. Today’s clinical trials generate a massive flow of data, raising crucial questions about how to ensure data integrity and authenticity. Fortunately, we can automate many procedures using digital tools, which reduces staff burden and nearly eliminates the need for manual data checks. We typically propose an optimal toolbox to prevent incorrect data collection, identify erroneous or missing data, and streamline data cleaning. We develop an effective clinical data management strategy based on the study design and the complexity of the CRF.

We have also built strong communication between the Data Management, Clinical Operations, and Biostatistics departments to perform medical monitoring, safety reporting, and medical coding.

Pharmaxi’s Data Management Services:

Data management planning (Data Management Plan, Data Validation Plan).
CRF annotation.
Development of the database structure and database specifications.
EDC system management (OnlineCRF or other EDCs): configuration, validation, preparation of the documents in accordance with GCDMP, edit-check programming, account management, etc.
Performing User Acceptance Testing.
Data review and data cleaning (medical monitoring, identification of data discrepancies and outliers, cross-checks, logic checks, query generation/resolution).
Performing risk-based monitoring.
Medical coding (MedDRA and WHODrug).
Pre-DB closure activities, soft lock, hard lock.
Dataset formation and assembly.
Blinded Review Meeting preparation and conduct.
Provision of full-service Data Management and Functional Service Provision (FSP) arrangements.

Our main purpose is to offer you the activities that best suit your project needs, while ensuring our proposal is reasonable as well as both cost and time efficient.

Contact us with your questions or concerns. We offer a free half-hour consultation with a clinical trial expert to discuss your request.