Clinical Data Management

Data-management.pngCytel offers a full range of data management services that can be combined with our existing statistical expertise to provide a value added offering to our clients. We handle clinical studies of all sizes, from Phase I – IV, in FSP Model as well as stand-alone projects.

Our Clinical Data Management team leverages best practices from across our existing capabilities of statistical software products and services. The result is reliable, best-in-class technology, and the domain awareness needed to address the dynamic business needs of Pharmaceutical and Biotechnology companies.

Our commitment to ‘Quality First’ includes uncompromising attention to streamlined workflows and predictable timelines, so that every aspect of the project receives proper care and accountability. Our teams understand that there is no excuse for delay. Some of our team members have been working together for over a decade, thanks to low turnover rates, and have mastered the ability to deliver quality on the dot.

Clinical Data Management Services

  • Project Management
  • Data Management Plan
  • CRF Designing
  • Customized Database Design, Screen Testing & Development
  • Edit, Validation and Design check programming, UAT
  • Double Data Entry, Comparison and Adjudication
  • Independent Verification – Data Entry Quality Control
  • Data Validation
  • Data Cleaning
  • Query Management
  • Dictionary Services (MedDRA, Who-DD or your own dictionary)
  • Local Lab Data Management
  • Patient Diary Data Management
  • 3rd Party Vendor Reconciliations
  • Serious Adverse Event (SAE) Reconciliation
  • Manual / SAS® Data Listings Review
  • Quality Control – Sample QC & Critical QC and Data Quality Audits
  • Database Soft & Hard Lock and Export to SAS®
  • Delivery of Clean Data Files, Database Release & Documentation of Clinical Data Management Report
  • Data Archival and Storage


Key Value Proposition

  • Improved operational efficiencies which can be measured through metrics
  • Significant and easily realizable cost benefits and productivity enhancement through process improvements
  • Transparent communication and robust governance
  • Synergies derived out of Clinical Data Management (CDM) & Biostatistics Team working together
  • Enabling organizations to focus on their core areas of operation thereby reducing their costs

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