Monthly Archives: March 2017

The effects of rigorous patient advocacy are easily seen today throughout the pharmaceutical industry. Patients who suffer the debilitating effects of rare diseases are banding together to be heard in an attempt to have their conditions studied to further the development of treatments and cures. However, the influence of patient advocacy groups has not alwaysRead more

DURHAM, N.C., MARCH 27, 2017 — A therapeutic revolution is changing the lives of many afflicted with severe psoriasis. New treatments are breaking the cycle of patient “heartbreak” made famous in product advertising decades ago. Premier Research will explore these advances in a webinar on Wednesday, March 29. Dr. Howard Welgus, Executive Medical Director for Dermatology,Read more

DURHAM, N.C., March 27, 2017 — Two Premier Research drug development experts will speak at the Drug Information Association’s EuroMeeting 2017, March 29-31 in Glasgow: Dr. Thomas Laage, Senior Medical Director, will take part in a session on optimizing development of pediatric medicines on Thursday, March 30, from 11 a.m. to 12:30 p.m. Dr. LaageRead more

  DURHAM, N.C., MARCH 24, 2017 — Premier Research is launching a smartphone-based patient reported outcome system to replace the paper diaries used in many clinical trials. Premier Mobile ePRO will give sponsors and researchers more accurate and timely patient reported data while reducing the burden on trial participants. “Any study is only as goodRead more

Translational research has the potential to help all patients, but the principles behind bench-to-bedside research hold special promise for patients with rare diseases — many of which have no standard treatments. Here’s how changes to the way rare oncology studies are performed are getting treatments to the patients who need them at a faster rate. What MakesRead more

In December 2016, the United States passed an important piece of regulatory legislation called the 21st Century Cures Act. These FDA regulations cover multiple types of clinical research but include some specific provisions for medical device development. In contrast to the regulatory reform seen in the EU — which includes a much-needed increased emphasis onRead more

Good clinical practice (GCP) guidelines govern important aspects of clinical trials to ensure patient safety and scientific integrity. “GCP” is a quality standard which refers to the document put forth by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH is a group made up of regulatory officialsRead more

In general, greater certainty about the clinical benefit of a drug correlates with an increased time to achieve needed results — the best evidence can take years of careful follow-up. But an unnecessarily long time to market isn’t good for sponsors and patients alike. This is especially true for patients battling rare cancers: With many of these conditions lacking standard treatments,Read more

Traditional trial design use only a priori inputs to obtain final trial results. From first patient in to last patient out, trial execution proceeds without change, following a black box approach. While a standard for clinical research, this strategy doesn’t always suit rare oncology research, which must contend with very small patient populations that are often difficult to treat.Read more

What are sponsors in medical device trials responsible for? Pretty much everything. Seriously. Clinical trials for medical devices involve many complex “moving parts” in the form of different groups of investigators, suppliers, contractors, committees, and other organizations. For a successful trial, sponsors must make sure each works together in harmony. Roles of a Sponsor The seven keyRead more

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