SCORR Marketing, along with KNect365 Life Sciences, a global community of pharma stakeholders, has produced a report on the current status of patient centricity in clinical trials. The survey collected 208 responses from industry professionals in a variety of job functions and regions. The survey tried to determine if companies are taking patient preferences into consideration and, if so, how they are doing so.
Abeona Therapeutics is named after the Roman goddess who was the protector of children as they start out on their journey. Since launching as a private company in 2013, Abeona has partnered with a dozen international foundations to fund its development efforts. Currently it is seeking a treatment for children with Sanfilippo Syndrome, and engaging caregivers to determine how to best meet the needs of patients taking part in trials.
Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.
Many of the innovations applied to healthcare in recent years, such as wearables and other mobile devices, have served to collect precisely this kind of information. How far does a given patient walk every day? How much sleep does she get every night? Devices that answer questions like these are expanding the concept of precision medicine to include more than just genetic data.
Several recent analyses have called attention to the increased scientific and operational complexity of today’s clinical trials.
At INC Research/inVentiv Health we have the ability to expedite clinical programs and build the foundation for continued development of the product.
According to FDA Draft Guidance published in March 2010, a pharmacokinetic (PK) study should be conducted in patients with impaired renal function when the drug is likely to be used in such patients and when renal impairment is likely to mechanistically alter the PK of the drug and/or its active metabolites.
A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.
INC Research/inVentiv Health Late Stage leaders help world–class companies bridge the gap from development to commercialization.
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
PAREXEL International (NASDAQ: PRXL), a leading global biopharmaceutical services organization, today announced the launch of its Perceptive MyTrials® Data-Driven Monitoring solution. Developed by PAREXEL Informatics, it is a key component of the Perceptive MyTrials eClinical platform, an integrated suite of applications for managing clinical trials.
On-site monitoring is a critical aspect of trial management, with the primary function of identifying and mitigating patient safety or data quality risks at investigative sites. The U.S. Food and Drug Administration (FDA) and other regulatory bodies have issued guidance to assist sponsors in developing risk-based monitoring strategies that enhance patient protection and improve trial data quality through more effective study oversight. They have encouraged greater use of centralized monitoring methods to evaluate clinical trial conduct and progress.
inVentiv Health, Inc., offering best-in-class clinical, commercial, and consulting services to the healthcare industry, recently announced that it has taken an equity stake in Mytrus, Inc., a pioneer in “virtual clinical trials” and technologies such as electronic informed consent to improve trial efficiency.