One of our greatest strengths is data management service. We have already been entrusted with data management by such companies as Draeger, MSD, and small biotechs like Peptigroup and Sankom. We are ready to achieve the same success for you!
We have developed an EDC system that maximally adapts to your specific project. We use it in our
projects and considers which functions can be improved to make the system work in a more
EDC system is the most flexible solution for any cooperation format. We adapt, select, and provide the most convenient and effective option for its application. We also work with data from other systems. Our data managers are qualified to work with other systems, as they are direct developers and creators, and they deeply understand any complexities and features of electronic data collection systems.
Pharmaxi's Data Management Services include:
- 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 goal is to provide you with the services that best suit your needs, as well as to make our offer reasonable, time- and cost-efficient.
Contact us to discuss any questions or concerns. We kindly provide a free half-hour consultation with our expert to discuss your request.