CROs & Sponsors Address Global Compliance Challenges
April 29th 2016Sponsors and their contractors have faced challenges when ensuring that parties involved in global clinical trials adhere to rules and regulations regarding biomedical research. For an effective collaboration to take place, all parties must meet the expectations and accountabilities detailed in the trial contract.
eBook: Cardiac Safety Assessment Update
April 28th 2016This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT-a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments-offers expert view on this regulatory change.
Will Another Recession Bash the Biopharmaceutical Industry?
April 28th 2016Some in the financial industry have argued that we may be in the midst of another economic recession. The biopharmaceutical industry has shown resiliency during such times and industry trends point to that being the case again.
New Diagnostic Criteria Narrows the Definition of Parkinson's Disease
April 26th 2016The Movement Disorders Society has recently published Clinical Diagnostic Criteria for Parkinson’s disease. These new guidelines allow for the diagnosis of clinically established and clinical probable Parkinson’s disease, which will help reduce errors in clinical trials.
Europe's Bid for Specialist Synergy Promises a Research Boost
April 25th 2016The European Reference Networks aims to join the efforts of the best specialists in Europe to tackle complex or rare medical conditions. The goal is to create networks covering a specific disease with an emphasis on procedures or techniques related to treatment.
Interexpert Agreement on Adverse Events’ Evaluation
Drug safety surveillance, a core focus of clinical trials, can be influenced by subjective judgement, as this analysis of differing expert assessments of adverse drug reactions-and the reasons why-shows.
Feasibility In the Age of International Clinical Trials
April 20th 2016The success of a clinical trial depends on the sponsor’s ability to effectively execute its programs. Both quality of research and aptitude to complete the study on time determine the likelihood of advancement of a product to the next stage of development.