Data management/IT

Data management service is one of our strengths. Clinical trial’s today generate a massive data flow and an important question is how to guarantee data integrity and authenticity. Fortunately, we are able to automate multiple procedures using digital tools which decrease the burden on staff and almost eliminate manual data checks. We usually propose an optimal toolbox to prevent incorrect data collection, identify erroneous/missing data, and efficient data cleaning. We develop an efficient clinical data management strategy depending on the study design and CRF complexity.

We also built a strong communication between Data Management, Clinical Operations, and the Biostatistics departments in order 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 EDC’s): configuration, validation, preparation of the documents in accordance with GCDMP, edit-check programming, account management, etc.
• Performing User Acceptance Test
• Data review and data cleaning (medical monitoring, identification of the data discrepancies and outliers, cross-checks, logic checks, query generation/resolution).
• Performing risk-based monitoring.
• Medical coding (The MedDRA and WHODrug).
• pre-DB closure activities, soft lock, hard lock.
• Datasets formation and assembly.
• Blinded Review Meeting preparation and conduct.
• Provision of full-service of 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.

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