Clinical Leader Newsletter: TransCelerate & DrugDev Form Investigator Partnership

Clinical Leader Newsletter | February 25, 2015
	Top Clinical Research Trends Of 2014 Dr. Bill Gluck, Vice President Clinical Knowledge, DATATRAK 2014 was a fast moving, controversial year for the clinical research industry. With so many choices, it is hard to provide a complete summary of all of the events or developments of the past year, but presented in this white paper is a listing of key topics from 2014. Featured Articles Hepatic Impairment Studies In Early Development Services: Innovative Patient Pharmacology Models For Phase 1 To 2a Support By Gerd Arold and Nils Piwon, PRA Health Sciences PRA Early Development Services (EDS) has established a group of experts dedicated to early-phase patient studies. Our innovative Patient Pharmacology Services (PPS) features a unique scientific/medical and operational model that enables us to conduct studies in patients with hepatic impairment, following the same processes and guidelines that we apply to traditional Phase 1 or Phase 2a trials. The Important Roles And Selection Criteria For CRO Medical Teams For Oncology Development Programs By Anthony T. Everhart, M.D., FACP VP, Medical Affairs, Chiltern; Carlo Lanza, M.D., Ph.D., MSc, Senior Medical Officer, Chiltern; and Dr. Marco Romano, VP, Medical Affairs, Chiltern As researchers discover more about the biology of cancer therapeutics are becoming better targeted and more effective. Q&A With Dr. John Harrison: Part 4 — Technology Advancements In Alzheimer's Trials   By Heather Bilinski, Associate Director of Marketing, CRF Health This is the final part in the four-part series written following a Q&A session with Dr. John Harrison. During our conversation with Dr. Harrison we discussed the current problems with Alzheimer's clinical trials and the reasons behind the very low success rates for treatments. Spotlight On The TMF Reference Model   By Sharon Ames, Enterprise Program Director, NextDocs The Trial Master File Reference Model (TMF RM), a supported initiative of the Drug Information Association's (DIA) Document and Records Management Community, is a collaborative reference for the contents of a TMF. Membership has quickly grown, and by August 2014 comprises more than 350 members from more than 200 companies. Resources Address Rare And Respiratory Diseases And Improve Clinical Success With Metabolomics: Part 5 Passive Packaging: Reduce Costs With Superior Performance Most Popular News • TransCelerate Picks DrugDev To Develop Investigator Registry • Lilly Provides Update On Evacetrapib Phase 3 Trial • Draper Device Could Boost Confidence Of Pre-Clinical Trial Results For Hearing Loss Treatment Upcoming Training CRA Oversight: A Risk-Based Approach Date: Monday, March 2, 2015 • Time: 1:00 pm to 2:30 pm EST Subscribe Today   For insight on how pharma and biopharm executives can improve how they run their businesses, subscribe to Life Science Leader magazine.