Data management

CTCM offers consultancy and broad data management support for clinical research in several phases of the data life cycle and guides you in the data collection process and processing of study data. CTCM can support you in translating the study protocol into a suitable eCRF design in a validated Electronic Data Capture (EDC) system and linking it with other software tools if necessary. The recording and management of study data is documented in a study-specific Data Management Plan (DMP) and Data Validation Plan (DVP). During the study, the consistency of the data is checked (data cleaning) and the progress of inclusion and the quality of data collection are monitored. CTCM can provide you with the necessary datasets and reports for interim and endpoint analyses, DSMB (Data Safety Monitoring Board) meetings and safety reports to regulatory authorities. 

CTCM data management includes the following services: 
  • database/EDC design, development and validation
  • data management plan and data validation plan
  • data cleaning
  • randomization management
  • making data FAIR (Findable, Accessible, Interoperable and Reusable  
  • data transfer, integration, imports and exports
  • coding of medical terminology (in accordance with MedDRA/SNOMED)
  • SAE reconciliation

CTCM offers multiple data management applications, such as validated EDC systems, randomization tools, ePRO, eConsent and study planning applications. For this we work with Castor, MACRO, Alea and YourResearch, among others. 

Geef uw mening over de website, of vertel ons hoe wij onze website kunnen verbeteren.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.