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Standardized process for every step of the way

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Clinical Data Management (CDM)

After the active phase of a clinical trial, data are all that remain. DataClin has the expertise and knowledge about this critical phase in clinical research. This leads to presenting high-quality, reliable, and statistically sound data from clinical trials.

Our Clinical Data Management team has records of achievements this industry spanning over many therapeutic areas and almost all clinical research phases in addition to post-marketing product registries and diseases registries. We realize the importance of minimizing time needed for executing data management steps -from CRF development to Database Lock- while ensuring the maximum quality of data which keeps our clients ahead of the competition by means of faster publications/product commercialization.

Our team works according to a full set of standards including local and international guidelines in addition to DataClin SOPs and sponsor’s SOPs. All data management steps are subject to regular quality audits conducted by highly qualified auditors and accordingly a continuous process of updates. We conduct Electronic Data Capture (EDC) studies and paper based studies as per sponsor’s request.

 

For Clinical Data Management (CDM), we provide the following solutions:

  • Data Management input in study outlines and study protocol
  • Case Report Form (CRF) design, development and annotation
  • CRF completion guidelines and investigator’s training
  • Data management plans including; data validation and self evidence correction plans
  • Database design, build, validation and testing (paper or EDC)
  • Edit-checks (validation rules) design, development and testing
  • Paper CRFs tracking and imaging
  • Clinical Data Entry (Independent double data entry or single entry with 100% review)
  • Discrepancies management
  • Data Extracts, listings and reports
  • Manual/ medical review of listings
  • Medical Coding
  • SAE reconciliation
  • Final Database Quality Audit
  • Paper CRFs archiving
  • Project Management and Mock-up reports
  • Data Mangement training and consultancy

 

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