Theorem Clinical Research

CTTI

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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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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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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