Ethics/Regulatory

NIH forms team to chart course for Precision Medicine Initiative research network

Wednesday, April 1, 2015 01:08 PM

A newly created team of experts in precision medicine and large clinical research studies will seek public input from the large and diverse stakeholder community interested in the development of the President’s Precision Medicine Initiative and articulate the vision for building the national participant group for the Initiative. They will help define what can be learned from a study of this scale and scope, what issues will need to be addressed and considered as part of the study design and what success would look like five and 10 years out.

More... »

Quest Diagnostics

Report: Transparency, cooperation help reduce high prices for new medicines

Friday, March 27, 2015 11:19 AM

As the number of new medicines introduced in Europe rises, governments are finding it increasingly difficult to afford them, according to a comprehensive study released today by the WHO Regional Office for Europe. The study illustrates the challenges for national health systems, with specific examples, and shows that few countries in the WHO European Region have mechanisms in place to evaluate the cost-effectiveness of new drugs; this hampers the value-assessment and decision-making processes.

More... »


Cancer Innovation Coalition focuses on Precision Medicine Initiative

Wednesday, March 25, 2015 03:02 PM

The Cancer Innovation Coalition (CIC) has called on government leaders to put patients first when introducing new legislation and implementing President Obama's Precision Medicine Initiative.

More... »

BRANY earns five-year AAHRPP accreditation

Wednesday, March 18, 2015 01:20 PM

BRANY has successfully continued its full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The five-year accreditation reflects BRANY’s continuing commitment to protecting the rights and welfare of research participants. AAHRPP’s accreditation process helps organizations consistently meet ethical principles and standards for protecting research participants.

More... »

Study: How much should cancer drugs cost?

Monday, March 16, 2015 01:54 PM

The true cost of cancer drugs is 30% less than a decade ago, once longevity and quality of life are considered, according to a Cornell University researchers based on a study, A Quality-Adjusted Price Index for Colorectal Cancer Drugs, released by the National Bureau of Economic Research (NBER).

More... »

Western Institutional Review Board receives ISO 9001:2008 certification

Monday, March 16, 2015 08:00 AM

WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services and software, has announced Western Institutional Review Board (WIRB) has been certified to ISO 9001:2008 by BSI, confirming it operates an excellent quality management system.

More... »

U.K. industry paid $456.7M in 2014 to underwrite medicines bill

Friday, March 13, 2015 12:28 PM

The Association of the British Pharmaceutical Industry (ABPI) and the U.K. Department of Health have announced a fourth quarter payment from industry of $119.3 million to underwrite the growth of the medicines bill under the 2014 Pharmaceutical Price Regulation Scheme (PPRS). This takes the total payment made by industry during 2014 to $456.7 million.

More... »

FDA approves first biosimilar Zarxio from Sandoz

Friday, March 6, 2015 12:24 PM

Sandoz, a Novartis company, has became the first company to receive approval of a biosimilar in the U.S. through the new FDA biosimilar pathway established under the Biologics Price Competition and Innovation Act.

More... »

FDA launches drug shortages mobile app

Thursday, March 5, 2015 12:34 PM

The FDA has launched the agency’s first mobile application specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

More... »

Pearl IRB granted AAHRPP accreditation

Thursday, February 26, 2015 03:32 PM

Pearl IRB, an Indianapolis-based provider of central IRB review services, has received accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

More... »

CWWeekly

March 30

Icon, Carnegie Mellon partner to research ways to improve study patients' understanding of Informed Consent

Veeva launches OpenKey, partner program to unlock difficult access to, restrictions on customer reference data

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs