Theorem Clinical Research

Global News

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.

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Quest Diagnostics

Par Pharmaceutical files for IPO

Friday, March 13, 2015 12:55 PM

Par Pharmaceutical Holdings has filed a registration statement with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of its common stock. The number of shares to be offered by Par Pharmaceutical and its shareholders, and the price range for the offering, have not yet been determined.

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Ember, Mariel Therapeutics ink merger agreement

Friday, March 13, 2015 12:33 PM

Ember Therapeutics, a Boston-based biotech discovering and developing novel obesity and diabetic related therapies, will merge with Mariel Therapeutics, a privately held, New York-based biotech developing targeted therapies for osteoarthritis and kidney fibrosis using Bone Morphogenetic Protein (BMP)-7.

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Society for Clinical Research Sites expands relationship with Acurian

Friday, March 13, 2015 12:30 PM

The Society for Clinical Research Sites (SCRS), a Ellicott City, Md.-based global trade organization representing clinical research sites, has announced an expanded relationship with Acurian, a full-service provider of global patient enrollment and retention solutions and a subsidiary of PPD.

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Icon rides latest outsourcing wave with launch of medical device and diagnostics research group

Friday, March 13, 2015 12:26 PM

Global CRO Icon has packaged a combination of its services to create a medical device and diagnostics research group designed to provide global clinical trials, health economics and pricing and market access tools.

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23andMe to create therapeutics group, names Richard Scheller CSO

Thursday, March 12, 2015 01:03 PM

23andMe, a personal genetics company based in Mountain View, Calif., has created a new therapeutics group and has named Richard Scheller, Ph.D., to lead it as chief science officer and head of therapeutics. Scheller retired in December 2014 from a 14-year career at Genentech, where he was executive vice president of research and early development.

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Report: Declining Ebola cases pose serious challenge to clinical studies

Thursday, March 12, 2015 01:01 PM

The steady decline in new Ebola cases presents a formidable challenge to current and future clinical trials of investigational treatments for the disease, as it will be more difficult to recruit study participants and demonstrate efficacy, said an analyst with research and consulting firm GlobalData.

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GSK establishes Asian global headquarters in Singapore

Thursday, March 12, 2015 01:00 PM

GlaxoSmithKline is strengthening its presence in Singapore by establishing a new global headquarters for Asia, further expanding its commitment to patients and consumers in the region.

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Endo bids to acquire Salix for $11 billion

Thursday, March 12, 2015 12:58 PM

Raleigh, N.C.-based Salix Pharmaceuticals has received an unsolicited proposal from Endo International, a global specialty healthcare company headquartered in Dublin, Ireland, to acquire all outstanding shares of common stock of the company for a combination of 1.4607 shares of Endo common stock and $45 cash per share of common stock. Based on the closing stock price of Endo on March 10, 2015, the transaction is valued at $175 per Salix share. 

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NIH-led study to assess community-based Hepatitis C treatment in Washington, D.C.

Thursday, March 12, 2015 12:52 PM

Officials from the National Institutes of Health and the city of Washington, D.C., launched a clinical trial to examine whether primary care physicians and other health care providers, such as nurse practitioners and physician assistants, can use a new antiviral therapy as effectively as specialist physicians to treat people with hepatitis C virus (HCV) infection. The trial, which will involve 600 adult D.C. residents infected with HCV alone or co-infected with HCV and HIV, also will examine the long-term effects of the treatment.

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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

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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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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