Clinical Data Management

Our Clinical Data Management professionals provide the industry’s highest quality services in this functional area with accuracy, efficiency and flexibility. Our Clinical Data Management group members have decades of experience covering the entire clinical trial data lifecycle and proven expertise in supporting clinical trials for biotechnology, pharmaceutical, and medical device companies. We offer our services as a complete package customized to our client’s needs and as singular services in order to quickly remedy a specific need. Our Data Management team has strong technical skills, industry related education, as well as customer service and communication skills.

The USDM Life Sciences Clinical Data Management experts provide our clients with customized services in data standards development, data conversions, process validation, data warehousing and archiving, data security and standard operating process documentation. In summary, the USDM name says it all, we are the country’s leader in Data Management services and we go above and beyond the services offered by our competitors. We ensure and facilitate compliance through the entire multi-faceted clinical data lifecycle.

Data Management Services:

  • Protocol Review
  • DM Systems specification, development, change control management and user acceptance testing (eDC, ePRO, IRT)
  • eCRF/CRF Development
  • DM Documentation (DMPs, Edit Specs, Completion Guidelines, DTAs, Reconciliation Plans, etc.)
  • Study Conduct Data Management (Data Entry, Data Monitoring, Querying, Maintenance and Reporting)
  • Medical Term Coding (MedDRA, WHO Drug)
  • Third Party Data Integration
  • Lab Data Administration
  • Database Auditing, Closure (Lock) and Extract/transfer
  • Data Standards Development (CDISC, SDTM, CDASH and ADaM)
  • CDISC Data Mapping and Conversions
  • Clinical Data Warehousing and Archiving
  • Data Security
  • Data Migrations
  • “At Risk” Study Rescue and Remediation
  • SOP Development

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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