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Data Management Services

Experts in data collection and risk based data management

Our in-house team of Data Managers has broad experience across different industries, in all major therapeutic areas and phases of development. We are a Nordic team with global reach that has supported clients in more than 30 different countries. With proven results through over more than 500 eCRF builds completed we are true experts in designing tailormade clinical databases that meet the unique needs of your project. By using the latest technologies for data capturein combination with well-integrated and efficient Data Management processes we secure data integrity and quality, empowering you to make informed decisions. Collaboration is at our core; we seamlessly collaborate with your team to ensure short timeframes for study deliverables.

  • eCRF design – development of an advanced and user-friendly eCRF with built-in edit checks facilitating real-time data cleaning and managed by a dedicated Project Manager.
  • eCRF training – clinical sites and sponsors will be trained by our Data Managers to ensure effective use and good understanding of the eCRF system.
  • Data sampling strategies – our Data Managers will work with you to ensure capture of high quality data.
  • User management – sites and users are managed by dedicated Project Managers to ensure appropriate access during the trial.
  • Data Management Plan – we develop a detailed plan for study data capture and handling from study start to database lock.
  • Patient Reported Outcomes/ Clinical Outcome Assessments – all patient input can be seamlessly integrated in the eCRF and study participants can report their own data online for maximum flexibility.
  • Data integration – your dedicated Data Manager will ensure seamless integration of external data into the eCRF.
  • Data entry – our processes ensure high quality transfer of study data from paper or other sources to the clinical database for your trial.
  • Study specific reports – depending on your requirements we can develop tailored study reports for your trial.
  • Risk-Based Data Management – risk based approaches are implemented in all our clinical trials and we use centralized approaches for monitoring data quality.
  • Data review and validation – our Data Managers regularly review trial data and solve discrepancies by efficient query handling processes. Standard reports provide study status in real time.
  • Database lock and decommissioning – datasets and documentation of data collection, handling, management and processing are safely transferred to Sponsor at study end.
  • Medical Coding – our trained Medical Coders can perform coding according to ATC, MedDRA, and/or WHODdrug dictionaries.

Related links

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Video: Successful CRO Navigation – A US client perspective on selecting the right CRO, Data Management and collaborating with LINK Medical over a decade

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