Data Management

  • Logistical Planning to facilitate data collection and reporting for critical path decisions
  • Electronic Data Capture – our technical data managers have an array of experience in both our Technology Transfer platform (Merge etrials) and other EDC systems contracted by our sponsors including Medidata RAVE, Nextrials Prism
  • CRF Design by a Data Management team experienced with CDASH and CDISC standards including development of well documented, focused CRF completion instructions to assure consistency and accuracy of data across the life of your clinical trial.
  • Edit Check Design to maximize identification of incomplete and discrepant data at the point of entry. Edit checks and messages are programmed and a specification report exported for review of completeness and accuracy by our internal team and the sponsor. Once changes are incorporated, final, documented user acceptance testing (UAT) is performed.
  • User Acceptance Testing of CRF and Edit Checks to assure completeness and accuracy based on the study protocol and other key study documents.
  • Data Management Plan contains details of data collection processes and systems used on your study including activities required by each functional team to assure the overall integrity of the study database throughout the study.
  • Data Review by a seasoned data management team with an average of 12+ years experience in several therapeutic areas including Oncology, CNS, Dermatology, Respiratory and Vaccines. Our data managers are the bridge between the clinical operations and biostatistics teams assuring that (1) the data accurately reflect what occurred in the field and, (2) the data are accurately presented in analysis displays.
  • Medical Coding using MedDRA and WHODrug dictionaries (versions maintained to meet your requirements). Our data coders have performed coding as part of data management services as well as post hoc as required for specific client requests (e.g., ISS, marketing information for data not previously coded, re-coding of legacy studies, supplement coding team for large programs).
  • Electronic Data Transmission Management including developing specifications and coordinating programming and testing activities, as required, for integration of data from 3rd party vendors into the study database.
  • System Integration is coordinated by the Data Management team in coordination with other functional areas as required for clinical studies including developing specifications for design of data interface, database transmissions and performing UAT (e.g., IWRS, electronic diaries)