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PRA Health Sciences - Drug Development Solutions Case Studies

PRA Health Sciences - Drug Development Solutions

Diagnostic Research Program Success Non-invasive screening for fetal aneuploidy: a new maternal plasma marker.
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PRA's Unique Model Leads to Client Satisfaction - Project Team Uses Innovation and Flexibility to Overcome Challenges A randomized, double-blind, placebo-controlled, Phase II study evaluating the ecacy and safety of Study Drug A in combination with Study Drug B administered as first-line treatment to subjects with unresectable, locally advanced, or metastatic pancreatic adenocarcinoma.
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PRA's Feasibility Leads to Unique Enrollment Strategy PRA recently performed a feasibility study to identify investigators who see patients with a rare neuromuscular autoimmune disease and who have the capability to perform a Phase II clinical trial. It was estimated that there may only be 1,000 to 3,000 patients in the US and Europe with the condition.
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PRA's Unique Model Leads to Client Satisfaction A randomized, multi-center, double-blind study to compare the e cacy and safety of Study Drug A and Study Drug B as monotherapy in newly diagnosed partial epilepsy.
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Challenging Study Timeline Goals Achieved in Global Post-Authorization Safety Study (Pass) A global real world safety study program, mandated by various regulatory bodies, to confirm risk/benefit profile for a novel oral anticoagulant. The first study was designed to generate data on the effectiveness of the study drug to reduce the risk of stroke in patients with atrial fibrillation. The second study was designed to collate data from patients treated for an acute deep vein thrombosis with either the study drug or Standard of Care. Both studies investigated the bleeding risk associated with the study drug.
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PRA Delivers Study Start-Up Success A Phase IIa randomized double-blind, placebo-controlled, multi-center study to evaluate the ecacy, safety, and tolerability of of Study Drug when given Methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) who have had an inadequate response to conventional disease-modifying anti-rheumatic drug therapy (DMARD).
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PRA Optimal Recruitment Strategies Reduce Enrollment Timelines A Phase III trial comparing drug treatments in patients with advanced breast cancer previously treated with or resistant to an anthracycline and who are taxane resistant.
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PRA Rescues Diagnostic Cancer Study Comparison of the performance of a new in vitro diagnostic test for post-colonoscopy in subjects with colorectal cancer and pre-colonoscopy in subjects from a guideline-eligible screening population.
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PRA's Strategies Impress Client Tight Timelines, Last-Minute Changes — No Problem.
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Strong Site Selection Leads to Success PRA Screens Five Months Ahead of Schedule.
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PRA Successfully Rescues Phase II Hematology Study Effective Project Plan Identifies Risks, Enables Timely Transition.
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Meeting Enrollment Goals Problem-Solving Leads to Early Completion of Breast Cancer Study.
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PRA Exceeds Tough Enrollment Goals Service Delivery Model Drives Positive Results.
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Persistence Leads to High Enrollment PRA Convinces Client to Stick with Recruitment Strategies.
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