Friday, April 18, 2014
 

Data Management

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From database creation to database lock, Clinart provides conscientious care at every stage of data management, insuring reliable and verifiable data points. With comprehensive experience in managing clinical trial data, we work with our clients on creating proactive solutions to any challenge. Our Senior Data managers listen to specific clients’ needs; we are responsive and take responsibility for what we do to the best to ensure clients satisfaction. Our personalized, performance-driven approach ensures our clients receive clean data on time. Every time.

 

Clinart uses well-established and efficient processes for both paper-based and Electronic Data Capture (EDC) trials. We support clients in selecting the appropriate technology for each trial based on our experience with several EDC platforms used for clinical trials of variable size and therapeutic areas.

 

Study documentation is developed to document all steps of the data management process and study specific procedures that include Data Management Plan, validation checks specifications, study specific guidelines for SAE reconciliation, and medical data coding.

 

Quality control is built into each step of the process and is documented through a study-specific quality control plan.

Data Management Services includes:
  • Selection of Appropriate Technology and Processes for each Study.
  • Design/Development of Case Report Form/ eCRFs and Completion Guidelines as per CDISC standards.
  • Investigator Meeting Presentations.
  • Monitors meeting presentation and training.
  • Establishment of the Data Management Plan (DMP) and Data Handling Guidelines.
  • Database Design, Development and User Acceptance Testing.
  • Data Validation Checks Specification, Programming and Testing.
  • Patient/CRF Tracking, Entry, and Verification.
  • Double Data Entry, Automated Double Data Comparison and Synchronization.
  • Electronic and Manual Discrepancy Identification and Automated Data Queries (ADQ) Generation.
  • Medical Coding (MedDRA, WHO-Drug, WHOART, COSTART or Sponsor-developed).
  • Integration and Verification of External Electronic Data.
  • AE/SAE Reconciliation and Reporting.
  • Identification and Tracking of Protocol Violators.
  • Remote Data Access.
  • Standard CRF/eCRF and Query process Metrics, Trends, and Data Reporting.
  • In-stream Patient Closure and Quality Control Auditing.
  • Evaluability Meeting Preparation and Attendance.
  • Accelerated Database Lock.
  • Final Archiving and Imaging.
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