Study Conduct

Clinical Conductor CTMS releases first collaborative CTMS

Thursday, April 3, 2014 11:09 AM

Clinical Conductor, the industry’s first collaborative and configurable CTMS for organizations managing or executing clinical trials, created by Bio-Optronics, a provider of software and services to healthcare and life sciences organizations around the world, has released a new Clinical Conductor CTMS revolutionizing clinical trial collaboration. The financial capabilities of Clinical Conductor also have been strengthened by the release and provide users enhanced levels of clarity and granularity of their trial finances, allowing them to maximize profitability and more easily ensure billing compliance.

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Society for Women’s Health Research urges FDA to require trials to examine gender-based differences

Wednesday, April 2, 2014 02:09 PM

Seeking to increase the participation of women and minorities in all phases of clinical trials, along with greater reporting and analysis of gender differences, Phyllis Greenberger testified at an FDA hearing yesterday. She presented a series of recommendations and changes to how the agency handles the collection, analysis and availability of demographic subgroup data in applications for FDA-regulated medical products.  

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Annalisa Jenkins named IIR Partnerships’ Woman of the Year

Tuesday, April 1, 2014 01:43 PM

Annalisa Jenkins, former executive vice president, head of global R&D at Merck Serono, has been named IIR Partnerships’ Woman of the Year.

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CISCRP launches inaugural 5K run and walk

Tuesday, March 25, 2014 02:51 PM

The Center for Information and Study on Clinical Research Participation (CISCRP), an independent nonprofit, is launching an annual 5K run and walk event in San Diego this June to celebrate the volunteers who give the gift of participation in clinical research.

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Aptiv Solutions enables first surrogate endpoint-based adaptive clinical trials

Friday, March 21, 2014 11:05 AM

Aptiv Solutions, a global biopharmaceutical and medical device development services company, has released ADDPLAN 6.1, the first statistical software to enable the use of surrogate endpoints to expedite interim analysis decisions in adaptive clinical trials. With this tool, survival trials for cancer therapeutics and other trials with long-duration endpoints can now utilize adaptive designs to a far greater extent.

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Ameritox launches new method to assess medication non-adherence

Wednesday, March 19, 2014 01:01 PM

Ameritox, a provider of medication monitoring solutions, has introduced a new method to assist physicians in assessing medication non-adherence for patients with serious mental illness prescribed the antipsychotic drug Abilify.

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Harrington Discovery Institute opens annual grant competition

Wednesday, March 19, 2014 12:57 PM

The Harrington Discovery Institute (HDI) at University Hospitals (UH) Case Medical Center has opened its third annual grant competition to fund and support physician-scientists at major academic medical centers across the nation in their efforts to accelerate promising drug discoveries.

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U.K. forms early access to medicines scheme

Monday, March 17, 2014 01:41 PM

The U.K. government has announced a new scheme that aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization.

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PhRMA launches national campaign to increase diversity in clinical trials

Thursday, March 13, 2014 12:55 PM

The Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Minority Quality Forum have announced a first-of-its-kind national campaign to help increase diversity in clinical trials.

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EFPIA responds to new Clinical Trials regulation

Wednesday, March 12, 2014 02:23 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the political agreement reached by the European co-­legislators, with the aim of a rapid adoption of the new Regulation on Clinical Trials. However, the original objectives of this legislation should be remembered: to enhance efficiency in the clinical trials regulation process and, in turn, to boost the European Union's competitiveness as a place to conduct research and make for more efficient patients access to new innovative treatments. EFPIA believes some of the initial objectives of the legislation have been only partially achieved; therefore, the success of this legislation strongly depends on how it will apply in practice.  

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CenterWatch
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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