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.

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Plan Upfront

As with many aspects of clinical data management, and indeed clinical trials management in general, meticulous upfront planning is a must.

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PI Sign off

Getting PI (Principal Investigator) sign off is a critical step and also a potential delaying factor in getting to database lock. Ensure time to support PIs is in your timeline.

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Involve Statistics

Interaction between data management and statistics is important to ensure a streamlined and efficient approach. Make sure statistics are involved in the data cleaning plan.

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Create a Timeline

The timeline needs to include specific tasks and deadlines which are addressed to each stakeholder.

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Engage Sites

Address data issues early while the site is still engaged. This will ensure a much smoother process in the final stages before database lock.

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Address Data Cohorts

The clinical monitors can be provided with sets of data to be addressed (i.e. subjects by date randomized). Once addressed, the team can move on to the next cohort of data. This streamlines the process at the end.

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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