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ARG rescues Phase I oncology trial using TrialVista® CTMS

ARG rescues Phase I oncology trial using TrialVista® CTMS

ARG rescues Phase I oncology trial using TrialVista® CTMS

March 1, 2018

Challenge: A leading specialty pharmaceutical company focused on the development and commercialization of next generation therapies for cancer and immunomodulatory diseases was mired in an unsatisfactory engagement with an offshore CRO for a Phase I oncology trial. Clinical data was delayed weeks in the cleansing and verification stages of the process. The missing pages report was inconsistent, outdated, and included incorrect data.

Results: ARG performed a one-time data dump from the existing CTMS, analyzed the data and worked on-site to prompt corrections to the existing EDC system. The sponsor was extremely pleased with their access to realtime data from TrialVista® CTMS, and with the extremely detail-oriented and successful CRA work that Atlantic Research Group performed to rescue the study and to fix data and procedural problems created by the former CRO.

Lessons Learned: The ability to consistently hit milestones while simultaneously ensuring quality is a differentiating ARG characteristic. Following ARG’s exceptional performance in the Phase I oncology trial, we became the sponsor’s preferred provider for CRO services.

Preferred Provider Status for Atlantic Research Group

Preferred Provider Status for Atlantic Research Group

Challenge: A specialty biopharmaceutical company targeting the therapeutic power of plasma for the treatment of chronic, life-altering diseases like hemophilia […]

February 1, 2018
ARG successfully starts up a Phase II trial within 6 weeks

ARG successfully starts up a Phase II trial within 6 weeks

Challenge: In an economic downturn, small biotech companies often depend on clinical milestones in order to maximize shareholder value and […]

May 1, 2018
Pivotal Phase III trial undergoes audits by the FDA and sponsor

Pivotal Phase III trial undergoes audits by the FDA and sponsor

Challenge: A pivotal Phase III clinical trial of C1 inhibitor for the prophylactic treatment of hereditary angioedema managed by ARG […]

June 1, 2018
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