Study Conduct

Biologics Consulting launches Clinical Trials Planning and Oversight Group

Wednesday, June 8, 2016

Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, has launched its Clinical Trials Planning and Oversight Group. The group will help small and medium-sized biopharmaceutical companies in the development and management of efficient and cost effective clinical trials. Biologics Consulting has a broad range of global clinical trial experience and clinical operations expertise that it will leverage to help clients design trials to meet the ethical, regulatory and scientific standards required to obtain successful product development outcomes.

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IMS Health acquires Privacy Analytics

Monday, June 6, 2016

IMS Health has acquired Privacy Analytics, a provider of technology solutions for de-identifying and anonymizing healthcare information, to extend its Real-World Evidence (RWE) capabilities. Affirming IMS Health’s long-standing practices for safeguarding patient privacy, the acquisition advances the company’s ability to help life sciences clients drive R&D and commercial performance and demonstrate treatment value in real-world settings. It also reinforces IMS Health’s role as a partner of choice for health systems, payers, providers and researchers as they seek new insights from healthcare data—with strong support for responsible privacy management.

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Decreasing adverse events in a clinical research unit: A quality improvement project

Wednesday, June 1, 2016

Clinical research units provide a safe environment to conduct clinical trials that lead to new advancements in healthcare modalities for patients. Many regulations govern the conduct of clinical trials with human subjects, and with regulations come many ways in which research units have to report any event that is potentially related to the intervention being tested. These reports are classified as either adverse events or serious adverse event reports. An adverse event is a side effect that may be harmful and/or caused by the intervention.1 An adverse event can be either an observed event that is partially or entirely due to the intervention or totally unrelated to the intervention, but still occurring while the intervention is being tested.1 Adverse event reporting consumes time for all involved in the research process, i.e., nursing staff, principal investigators, and sponsors. The time to complete the paperwork is a cost not only to the research team, but to subjects as well. The principal investigator spends hours following up with the subject and team, determining if the adverse event was related to the intervention, and then completing documentation supporting the decision. This process, while important, can prolong the trial for weeks and may be completely unrelated to the actual intervention. Decreasing the number of adverse events, such as contact dermatitis secondary to electrocardiogram (ECG) electrodes, can also decrease the amount of time, money, and the discomfort to the participant during the conduct of research trials.

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Study: Biomarkers improve drug LOA exponentially

Tuesday, May 31, 2016

The Biotechnology Innovation Organization (BIO) released a study of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.

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