Data Management

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Providing efficient solutions without compromising data quality or integrity

Venn Data Management services/capabilities span the data life cycle from collection to archival. Data drives the whole clinical development process. A high-quality dataset is therefore essential for the success of your drug. Our clinical data managers provide a smooth less flow from first patient into database lock by providing efficient solutions, without compromising data quality or integrity. The close collaboration with our biostatistics team ensures a timely delivery of clean, high quality study results.

A one-stop-shop for data management and setup services

As a one-stop-shop we provide the full suite of Data Management and database set-up services, from planning and documentation (Data Management Plan and Data Validation Plan), CRF (EDC or paper) design and testing, diary card (or ePRO) and database design, data entry, discrepancy management, medical coding, SAE reconciliation and database lock activities. Our team has experience with a broad variety of electronic data capture (EDC) systems, allowing us to offer you a solution that suits your trial needs and budget.

Venn Life Sciences can support you with:

Clinical Data Management

  • A Data Management Plan
  • CRF development and database design based on CDISC Standards
  • Electronic Data Capture with a Viedoc preferred partner
  • CRF Completion guidelines, CRA/Site users training
  • A data Validation Plan, Edit check programming and testing
  • A Protocol Deviations Management Plan
  • A Safety Reconciliation Plan
  • Data cleaning activities, query management
  • A Progress reporting
  • A Patient profile, specific data listings
  • SAS database mapping (CDISC-SDTM)
  • Medical coding (MedDRA, Whodrug)
  • 3rd Party Vendor data integration and reconciliation
  • Local Lab management
  • Blind/Data Review Meeting organisation
  • Final QC steps, Database Lock and Database release
  • A Data Management Report
  • Archiving (FDA compliant)

Learn more about Data Management

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