Data Management

Triangle Biostatistics offers both electronic data capture (EDC) and paper-based data management options, giving Sponsors more flexibility with study design based on cost, timelines, study size and clinical strategy. We have significant experience working across multiple data management platforms paper allowing us the flexibility to meet the data management needs of our Sponsors. We offer innovative technologies, best practices, and solutions to data collection and data cleaning challenges that are both flexible and cost effective.

Our core competencies come from our experience in data management and our knowledge of biostatistics and data standards.

DATA STANDARDS

Clinical Data Standards is one of the services most in demand by our clients. Our unique advantage is the knowledge of the standards that our team has developed. Our experience and expertise in CDISC data standards improves the likelihood of successful submissions.

Our experts understand a wide range of industry clinical data standards and apply them to the needs of individual studies. We can collaborate with clients to ensure the appropriate standard is implemented from the beginning. For existing studies that do not adhere to a specific standard, we leverage knowledge and experience to transform metadata and produce deliverables that conform to an industry-wide or sponsor-specific standard.

The overall deliverable is a submission database that U.S. FDA or European Medicines Agency (EMEA) reviewers can use to easily confirm study analyses. This gives regulatory agencies confidence in the submission with fewer queries and an expedited review so that the drug may go to market sooner. We also deliver post-submission support for any queries your project may receive.

Triangle Biostatistics is a leader in the development and adoption of CDISC standards, including CDASH, SDTM, and ADaM.

DATA MANAGEMENT SERVICES

  • Data Management Plan development
  • Case Report Form (CRF and eCRF) design, printing/deployment, distribution
  • Electronic Data Capture implementation, site training and support
  • Data receipt, logging, and tracking
  • Data entry
  • Data review
  • Query management
  • Medical coding (WHO Drug and MedDRA)
  • Data quality assurance
  • Data management reporting
  • Secure vendor electronic data transfer and upload
  • Electronic Data Capture implementation and site training and support
  • CDISC (Clinical Data Interchange Standards Consortium) datasets