Amarex Achieves Exceptionally Fast "First Patient Screened" Deadline for Two Challenging Trials
Now Enrolling for a Phase IIb Trial Treating Patients with HPV-Induced CIN2/3
Germantown, MD, USA (May 27, 2014) – Amarex announced today, achievement of exceptionally fast "First Patient Screened" deadlines for two logistically challenging trials.
In the first trial, with the indication of Venous Leg Ulcer, the time from contract awarded to Amarex to the First Patient Screened was 87 days. The sponsor's Clinical Operations VP praised Amarex, noting that "this is a tremendous achievement when you consider we did not even have a protocol just 3 short months ago. It was a total team effort with focus and drive to get it done."
The second trial achieved the First Patient Screened at 85 days. This study is for an HIV medication and presented a number of challenges. The sponsor's President and CEO stated that "Amarex has brought a whole new level of excellence to [the trial]. We are very pleased with their performance for services ranging from all of our CMC to the Clinical trial activities."
Amarex's clinical experts employed their Parallel Processing approach, the company's method of optimizing efficiency through simultaneous execution of multiple trial initiation and conduct activities. Amarex looks forward to continued successes with both of these trials and thanks the sponsor teams for their partnership and trust.
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
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