Data Management Services

T

he generation and collection of large amounts of data are integral first steps in the process of conducting a successful clinical trial. The subsequent generation of meaningful information from this data, however, is the key to winning regulatory approval and market acceptance of a new medical product. Through innovative, customized biometric solutions, MedTrials partners with you to ensure the information generated from your data is valid, reliable, well organized, and accurately reported.

MedTrials integrates data management professionals into the project team from the beginning. This approach builds team identity, promotes collaboration and sharing of processes and ideas, ensures a systematic approach to standards and compliance, and enhances team communication. The result is a data management solution that is designed into the research process from the start.

There are a variety of data management options open to you when you choose MedTrials as your research partner. These options range from traditional paper-based data management systems to completely integrated electronic data management and project communication platforms. We recognize that the best solution for a given project will vary by client, budget, size of the study, therapeutic focus, and site selection and distribution. Our goal is to design the right solution for you.

Data Management Services:

  • Development of data management strategy, plan, and customization of systems
  • Design and development of CRF or eCRF and CRF completion guidelines
  • Development and programming of database and validated edit checks
  • Customized site training
  • Double data entry (for paper-based) or hybrid eResearch systems with a paper front-end
  • Data verification, cleaning, and validation
  • Query generation, resolution, and tracking
  • Adverse event and concomitant medication coding
  • Interim clean data transfer with preprogrammed graphing and tabulation
  • 100% QC audit of all key safety and efficacy variables
  • Tracking and tabulation of protocol deviations
  • Generation of final, validated data tables and reports