Case Study
Overcoming Adverse Event Challenges to Ensure Patient Safety in an Osteoarthritis Study
CASE STUDY Overcoming Adverse Event Challenges to Ensure Patient Safety in an Osteoarthritis Study The Implementation and Effectiveness Evaluation of Risk Management MeasuresOvercoming Adverse Event Challenges to Ensure Patient Safety in an Osteoarthritis Study The Implementation and Effectiveness Evaluation of Risk Management Measures Regions Germany Poland Sweden STUDY DESCRIPTION A double blind, placebo controlled, parallel group, randomized study to evaluate the safety, tolerability, and efficacy of a novel, orally available small molecule for treatment of pain in osteoarthritis (OA). PRA Health Sciences was contracted by a pharmaceutical company to conduct the sponsor’s study to determine the safety, tolerability, and efficacy of a chemical entity in patients with OA. During