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Data Validation Plan for Clinical Trials

What is a Data Validation Plan in Clinical Trials?

A clinical Data Validation Plan (DVP) is a document that describes the procedures to verify the validity of clinical trial data according to the protocol specifications. The DVP includes the conditions that clinical data must meet to be considered valid for analysis. Data consistency is tested by using edit check programs capable of detecting discrepancies due to inconsistent information, missing data, out-of-range data, and protocol deviations.

Sofpromed’s Data Management Services

Sofpromed is a biometrics CRO specialized in clinical data management services, including the development of data validation plans. Our clinical data management capabilities include:

  • Development of Data Management Plan (DMP)
  • Development of Data Validation Plan (DVP)
  • Case Report Form (CRF) design
  • Electronic Data Capture (EDC) systems
  • Clinical data cleaning

Sofpromed provides support to biotech and pharma companies conducting phase I-IV clinical trials in different therapeutic areas, such as oncology, cardiovascular, metabolic, central nervous system, dermatology, infectious, and respiratory diseases, among others.