Theorem Clinical Research

Global News

DPT Laboratories acquires Meda Pharmaceuticals’ facility, retains employees

Thursday, September 4, 2014 12:21 PM

DPT Laboratories, a Texas-based contract development and manufacturing organization (CDMO) with a specialized focus on semi-solid and liquid dosage forms, has acquired Meda Pharmaceuticals’ Lakewood, N.J., facilities.

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Synexus acquires South African site, expands global footprint

Wednesday, September 3, 2014 12:46 PM

Synexus, a U.K.-based site management organization, has expanded its global presence with the acquisition of a specialist clinical trial site close to Cape Town's international airport. This is its fourth dedicated research center in South Africa and brings Synexus’ global site count to 24, with three new centers opened in the last six months.

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Exelixis cuts 70% of employees following failed pivotal trial

Wednesday, September 3, 2014 12:41 PM

Exelixis, a California-based biopharmaceutical company developing small molecule therapies for cancer, has announced top-line results from the final analysis of COMET-1, the phase III pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed after treatment with docetaxel as well as abiraterone and/or enzalutamide. The trial did not meet its primary endpoint of demonstrating a statistically significant increase in overall survival (OS) for patients treated with cabozantinib as compared to prednisone.

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Onyx Scientific, Cancer Research U.K. partner

Wednesday, September 3, 2014 12:30 PM

Cancer Research U.K. is using Onyx Scientific, a U.K. CRO, to manage several of its drug development projects in a bid to maximize value.

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TransCelerate releases recommended approach for protecting personal data in Clinical Study Reports

Wednesday, September 3, 2014 08:20 AM

TransCelerate BioPharma has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others.

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The Pulse on Global Trials

Tuesday, September 2, 2014 07:00 AM

My last two columns have focused on regional guidelines for clinical trial recruitment, to provide context for engaging in advanced targeting and acquisition methods—such as online advertising, search engine marketing and social media—to engage prospective participants. 

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The CenterWatch Monthly, September 2014

Tuesday, September 2, 2014 07:00 AM
Today’s fastest, most economical sponsors

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Rally for Medical Research to urge Congress to prioritize NIH funding

Friday, August 29, 2014 11:21 AM

While the ice bucket challenge has raised awareness—and millions of dollars—for ALS research, participants from nearly 300 research institutions and medical advocacy organizations are taking a much drier, and broader, approach to fund raising.

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WHO recommends use of testing to help diagnose pre-cancerous cervical disease

Friday, August 29, 2014 10:33 AM

The World Health Organization (WHO) has issued new guidance recommending the use of p16 immunohistochemistry (IHC) testing to improve the detection of pre-cancerous cervical disease. In doing so, WHO is the first global organization to issue written recommendations on the use of p16 after the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) provided similar guidance in 2012.

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Orgentec Diagnostika to acquire Corgenix

Friday, August 29, 2014 10:32 AM

Corgenix Medical, a Colorado-based, worldwide developer and marketer of diagnostic test kits, has agreed to be acquired by Orgentec Diagnostika, a specialty diagnostics company headquartered in Mainz, Germany. The strategic acquisition will extend both companies’ global distribution networks and broaden their portfoliod of specialty diagnostic assays.

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CWWeekly

September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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