Fort Lauderdale, FL-December 15, 2009
A West Coast biopharmaceutical company specializing in small molecule medicines across a number of therapeutic areas, has selected OmniComm for its TrialMaster EDC solution for conducting a Phase I study. The 9-month, 2-site study is planning to enroll over 80 subjects.
“We look forward to working on this Phase I study and we are pleased that OmniComm’s eClinical solution, TrialMaster, was chosen by this sponsor,” remarked Stephen Johnson, COO of OmniComm Systems.
“Facing aggressive timelines, the Sponsor selected OmniComm based on its reputation for building studies quickly and staying within budget. Furthermore, it was important to the new client that OmniComm be able to support its internal data standards initiative.” OmniComm’s TrialMaster solution has supported the CDISC ODM, CDASH (including naming conventions and domain structures), HL7, E2B, and caBIG standards for years, and with the addition of CDISC SDTM, will be the first EDC Company to leverage all of the industry leading standards in a single solution.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.