Functional Expertise

Data Management

Clean and targeted data is the cornerstone to all analyses. That’s why data management is mission-critical to us. Our core competencies come from our vast experience in data management and our expertise in biostatistics and data standards.

Catalyst has significant experience working across multiple data management platforms, giving sponsors more options based on cost, timelines, study size, informational needs and clinical strategy. Combined with highly skilled data teams, our technology-agnostic model brings continual innovation and flexible and cost-effective solutions to data collection and data cleaning challenges. 

Data Management Services:

  • Study tool development (CRF, diaries, surveys, questionnaires)
  • Comprehensive data management plans
  • Database development, validation and testing
  • Data management, project management, study oversight and consulting support
  • CRO/vendor oversight
  • Medical data coding
  • Global data entry, cleaning and verification
  • Data import and data export specification preparation
  • Data processing for paper and EDC studies
  • CDISC (Clinical Data Interchange Standards Consortium) datasets
  • EDC system selection and partnerships
  • Data standards

Adherence to CDISC standards is required by the FDA, and Catalyst is a leader in the development and adoption of CDISC standards, including CDASH, SDTM and ADaM. Our teams have extensive experience converting raw data from a wide variety of sources and EDC systems to data standards, collaborating with you to ensure the appropriate standard is implemented from day one, improving the likelihood of a successful submission.

The overall deliverable is a submission database that FDA reviewers can use to confirm study analyses. This gives the agency confidence allowing for fewer queries and an expedited review so that your asset may go to market sooner. We also deliver post-submission support for any queries your project may receive.

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