Data Management and Data Warehousing

4Pharma delivers high-quality, cost-effective solutions to ensure the successful management and delivery of clinical trial data in accordance with your timelines and budget. We provide you with highly experienced pharma professionals to support you in these processes.

We act in senior roles to set up your data management process and environment, to plan activities, to supervise other service providers and to communicate with your partners and regulatory authorities.

Operative data management

We are the leading provider in the field of data management in Finland. Our experience and understanding of both paper and electronic data capture (EDC) processes and systems enables us to provide you with the correct solution for any project. Our Data Managers are also trained in the use of the latest standards including CDISC. These standards are used to enable efficient review, processing transmissions and the submission of data to the regulatory authorities.

Do you already have your data transferred to one central location at 4Pharma for data management and data warehousing in the format of current regulatory standards?

We offer a variety of services, including:

  • eCRF/CRF design
  • Database design
  • Data entry
  • Data validation
  • Discrepancy management
  • Medical coding (MedDRA, WHO-DD, ATC)
  • SAE reconciliation
  • Data integration
  • Data standardization (CDISC)
  • Data warehousing
  • Data migration
  • eData transfer
  • Consultation at any level


Compliance

Our data management processes and systems are continuously successful in audits performed in accordance with regulatory requirements (e.g. 21 CFR Part 11).
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