The European Medicines Agency (EMA) released the first guidance for biosimilar production in 2005. It facilitated the initial wave of registrations for human growth hormone, epoetin, and filgrastim biosimilars. In the United States, the Biologics Price Competition and Innovation Act of 2009, which became law in 2010, provided an abbreviated biosimilars licensure pathway. It wasn’t until 2012, however, that the FDA issued three draft guidelines intended to bridge the gap and enable a biosimilar program across Europe and the U. S.
The paper discusses the benefits and key considerations behind implementing a mobile strategy for patient data capture in clinical research, as well as analyzes how the use of mobile COA solutions can overcome practical challenges of capturing PRO measures through better quality, reliability, integrity and traceability of the collected data. The paper is co-authored by Brendan Mulhern of the University of Technology, Sydney, currently involved in the development of the EQ-5D-5L value set for England/UK and includes commentary from Prof. Nicholas Bellamy of the University of Queensland, author of the WOMAC and AUSCAN validated indices for Osteoarthritis.
The productivity rate of drug development continues to fall, with clinical trial efficiency a driving factor. Learn more about how adaptive clinical trials can improve both predictability and efficiency.
Selecting an IRT vendor is an important investment for your clinical trial. In this guide, you’ll learn how to reduce workload at the investigator site, increase protocol compliance, and increase patient engagement and retention.
Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority. However, suboptimal adherence is prevalent in ambulatory trials, in which outpatients are responsible for taking the drug according to the protocol-specified dosing regimen. Unfortunately, most methods for measuring medication adherence are inaccurate, which can result in costly phase III failures. This whitepaper focuses on a proven exception—automatic adherence measurement through electronic compilation of drug dosing histories. Electronic measurement enables a better understanding of drug safety and efficacy data, improving the likelihood of a successful trial outcome and more informed development decisions, leading to faster speed to commercialization.
Comprehensive 15-page eyeforpharma briefing featuring interviews with 19 senior clinical trial leaders, best patient centricity practices and executive action points from Eli Lilly, Genzyme, National Breast Cancer Coalition, CTTI, PCORI, UCB, Cancer Treatment Centers of America, Michael J. Fox Foundation and more
This white paper explores how medical imaging systems can improve sites' overall experience in an imaging trial, how processes designed to support sites ultimately benefit all trial participants, and how site staff burdened with fewer manual processes can spend more time with patients, get patients on therapy sooner and deliver results to sponsors faster.
Barnett offers training and recourses for Clinical Research Professionals. Included are several new training programs, all designed with a practical, job-focused purpose and the needs of our learners in mind. New training offerings include In-Person Seminars, Web-Based 30-hour Certification Programs, Web Seminars, and Publications.