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The CenterWatch Monthly, April 2015

Wednesday, April 1, 2015 08:42 AM

PSI, INC Research, Chiltern best with sites

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Quest Diagnostics

Survey: PSI, INC Research, Chiltern rated top CROs by investigative sites

Wednesday, April 1, 2015 08:00 AM

More than 1,900 global investigative sites rate the best CROs for which to work in a new survey conducted by CenterWatch, a provider of global clinical trials information. The survey results were released in the April issue of The CenterWatch Monthly newsletter.

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ACRES Blue Cloud IT Platform provides shared interface for clinical researchers

Monday, March 30, 2015 02:19 PM

The Alliance for Clinical Research Excellence and Safety (ACRES), a Cambridge, Mass.-based clinical research nonprofit organization, has launched ACRES BlueCloud, the first phase implementation of a shared multi-user interface to allow sponsors, CROs, regulatory agencies, funding agencies and IRBs to access millions of verifiable professional experience and training credentials, enabling long-sought sharing and mutual recognition of those credentials by multiple stakeholders.

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AcelRx restructures, reduces workforce 36%

Monday, March 30, 2015 02:17 PM

AcelRx Pharmaceuticals, a California-based specialty pharma focused on development and commercialization of innovative therapies for the treatment of acute pain, has restructured its work force as part of a plan to reduce operating costs and focus its financial and development resources on working with the FDA to seek marketing approval for Zalviso, as well as to continue the development of ARX-04.

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NIH awards $9M to speed development of health technologies

Monday, March 30, 2015 02:13 PM

The NIH has selected three new proof-of-concept hubs to help speed the translation of basic biomedical discoveries into commercial products, such as new drugs, devices and diagnostics, to improve patient care and enhance health. The hubs are part of the NIH-supported Research Evaluation and Commercialization Hubs (REACH) program and will be funded $9 million over three years.

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Glenn Kerkhof appointed chairman of the board

Monday, March 30, 2015 11:05 AM

George Clinical, a CRO focused on clinical development in the Asia-Pacific region, has appointed Glenn Kerkhof chairman of its board.

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Why we need more older patients in clinical trials

Monday, March 30, 2015 08:00 AM

As our population ages and medical advances increase life expectancy, drug developers are facing an emerging gap in clinical research: lack of evidence to guide treatment decisions for people over 65.

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Vtesse forms scientific advisory board

Friday, March 27, 2015 01:47 PM

Vtesse, a rare disease company focused on developing drugs for Niemann-Pick Disease Type C (NPC) and other severe diseases with great unmet need, has formed its scientific advisory board (SAB). Comprising experts from a range of fields including pediatrics, translational medicine, biomarker research and genetics, the SAB will advise on clinical and regulatory strategy as well as product development for the company's lead candidate, VTS-270.

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Parkinson's Biomarker Initiative expands genetic study

Friday, March 27, 2015 01:26 PM

The Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by the Michael J. Fox Foundation for Parkinson's Research (MJFF), is expanding to study individuals with a mutation of the GBA (glucosidase beta acid) gene. Participants will include people with or at increased risk to develop Parkinson's disease. Researchers hope that a greater understanding of the biology and clinical features of these participants will lead to therapies benefiting all Parkinson's patients and ultimately provide strategies to prevent disease onset.

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Mast to develop Vepoloxamer (MST-188) in chronic heart failure

Friday, March 27, 2015 01:15 PM

Mast Therapeutics, a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, arterial disease and heart failure, plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure. Encouraged by recently reported nonclinical results and input from experts in the field, the company expects to begin dosing in a phase II study of vepoloxamer in patients with chronic heart failure in the third quarter of this year.

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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

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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

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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

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