CTTI

Syndax appoints Dr. Briggs Morrison CEO, Michael Metzger president and COO

Monday, June 15, 2015 01:43 PM

Syndax Pharmaceuticals, a privately held oncology company based in Waltham, Mass., has announced that Briggs W. Morrison, M.D., is joining the company as CEO and a member of the board of directors, and Michael A. Metzger is joining the company as president and chief operating officer. Morrison joins Syndax from AstraZeneca, where he was executive vice president, global medicines development and chief medical officer. Metzger joins from Regado Biosciences, where he was president and CEO through the company's strategic merger with Tobira Therapeutics.

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CTTI issues new recommendations to improve quality in clinical trials

Monday, June 15, 2015 01:31 PM

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership to identify practices to increase the quality and efficiency of clinical trials based in Durham, N.C., has issued recommendations to improve the quality and efficiency of clinical trials by helping sponsors focus on study activities that are essential to the safety of trial participants and the reliability of study results, and to reduce or eliminate those activities that are not. 

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Investigator training efficiencies highlighted in new CTTI GCP recommendations

Friday, January 30, 2015 12:14 PM

The Clinical Trials Transformation Initiative (CTTI), based in Durham, N.C., has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials. GCP is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.

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CTTI forms patient leadership council to drive improvements in clinical trials

Friday, February 15, 2013 10:50 AM

 As part of an effort to improve the way clinical trials are conducted, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership to identify practices to increase the quality and efficiency of clinical trials, has formed a 16-member council to engage patient advocates in its mission.

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10 pharmas form nonprofit TransCelerate to accelerate R&D of new medicines

Wednesday, September 19, 2012 02:46 PM

Ten biopharmaceutical companies have formed a non-profit organization, TransCelerate BioPharma, to accelerate the development of new medicines. Participants include Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech and Sanofi.

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New executive committee named to CTTI

Friday, September 7, 2012 02:08 PM

The Clinical Trials Transformation Initiative (CTTI) has named a 14-member executive committee, resetting CTTI’s strategic direction and ensuring that the organization informs and facilitates meaningful improvements to clinical trial design and conduct.

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EMA joins FDA in growing movement toward risk-based monitoring of clinical trials

Monday, September 19, 2011 08:02 AM

Along with the FDA and the Clinical Trials Transformation Initiative (CTTI), the European Medicines Agency (EMA) is advocating for risk-based monitoring of trials, while at the same time saying current GCP rules render quality management in trials too costly and need to be reworked.

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FDA’s new guidance on monitoring clinical trials strongly encourages taking a risk-based approach

Monday, September 5, 2011 08:02 AM

Arisk-based approach to monitoring clinical trials: It’s the way to go now.

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CTTI report recommends risk-based monitoring

Monday, August 15, 2011 08:02 AM

Almost 90% of those conducting clinical trials within the commercial drug industry always perform on-site visits to their study sites. In contrast, about a third of academic, government or cooperative groups involved in research do. And yet, neither monitoring method is based on any evidence that it improves the quality of the data, as no such evidence yet exists.

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APPI Joins Clinical Trials Transformation Initiative

Monday, August 4, 2008 05:59 AM

The Academy of Pharmaceutical Physicians and Investigators (APPI), a nonprofit group of nearly 1,200 physician members involved in the clinical research enterprise, has joined the Clinical Trials Transformation Initiative (CTTI).

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CWWeekly

July 6

FDA sued by advocacy groups seeking hepatitis C trials data

Google to test health-tracking wristband to collect clinical trial data

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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