Clinical data management

When it comes to clinical studies, ClinSearch closely works with selected partners specialized in Data Management that possess all the standard tools used for clinical data management including but not limited to ClinTrial, Oracle® Clinical, MedDRA® and WHO Drug.

At ClinSearch, the Head of Data Management is responsible for all the strategic aspects that are crucial in the clinical data management:

  1. Selection of Data Management partners by audits
  2. Contract negotiation with the selected partner
  3. Validation of the task order based on contractual aspects
  4. Quality control of the Data validation plan
  5. Quality control of the Annotated CRF
  6. Quality control of the database set up
  7. Quality control of the data entry (single or blind/interactive double data entry)
  8. Tracking of Case Report Forms (CRFs) and Data Clarification Forms (DCFs)
  9. Management of data queries sent to investigators
  10. Preparation and management of Data review
  11. Consolidation of adverse events data across the clinical and the safety database.

This Premium process meets the highest scientific and regulatory requirements. It is designed for clinical evaluations aimed at obtaining market authorisation or reimbursement.

The process may be adapted according to the nature of the missions ClinSearch is been put in charge of.

Our standards are based on:

Let clinical evidence
support innovation

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