CTTI

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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Quest Diagnostics

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

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

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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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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