4Pharma - Beyond Your Data

Data management


Data Management

4Pharma delivers high-quality, cost-effective solutions to ensure the successful collection, 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.

We offer a variety of services, including:

  • eCRF and paper CRF design
  • Electronic data capture (EDC) by using ViedocTM
  • Customized database design and set-up
  • Documentation including data management and data validation plans
  • Data entry
  • Data validation and discrepancy management
  • Serious adverse events (SAE) reconciliation
  • Status reports
  • Data migration
  • eData transfer
  • Data standardization (SDTM)
  • Data warehousing
  • 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).

Want to know more?

Contact our specialist directly, we gladly answer your question.

Mikko Taalikka , Head of Data Management