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GCP in Medical News

GCP Helpdesk : Launch Announcement of gcphelpdesk.com

... Launch of gcp Helpdesk (gcpheldesk.com), first of its kind in th...July 28, 2009 -- Announcing the first HelpDesk for gcp in the world. A much needed platform to promote gcp awareness and education. Proper clinical resea...

Clinical Research Safety and Ethical Standards in Developing World Up to U.S. Levels, Report Says

...- be protected by the same level of safety and ethical considerations, and that they be afforded the same standard of care, including adherence to the gcp principles promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (I...

Minority Business Accelerator 2.5+ Client Strong Tool Lands Multimillion Dollar Deal With GE Healthcare

...orks to significantly improve the meaningful involvement of minority businesses and individuals in the economic engines that drive Northeast Ohio. The gcp mobilizes private-sector leadership, expertise and resources to create jobs and wealth and improve the economic vitality of the region. www.com...

Barnett Releases Reference Guide on Form FDA 1572--Statement of Investigator

...der in clinical education and training for all levels of staff involved in the drug development process. In addition, Barnett is the publisher of the gcp Q&A Guide, the PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook, and other well-known reference manuals that help research facilities e...

DIA Innovation Forum to Highlight Latest Initiatives in Research & Development in the EU

...nd EMEA Implementation EU Commission and EMEA Implementing Technical Requirements Risk Management, Pharmacovigilance and Traceability GMP and gcp Issues Participants will be briefed on the latest initiatives in Europe to support innovation in research and development and will be able to share...

Catalyst Pharmaceutical Partners, Inc. Names Director - Corporate Clinical Compliance

...tment of Patrick Kenny as Director - Corporate Clinical Compliance. In this capacity, Mr. Kenny will be responsible for ensuring the effectiveness and gcp compliance of the CROs, clinical contractors and clinical trial sites involved in the clinical trials conducted under Catalyst's sponsorship. Commen...

DuPont Hosts Meeting of Leading Plant Scientists to Improve World Agricultural Productivity

...orn hybrids with enhanced drought tolerance. The gcp is a broad and true network of partners from advan...e crop productivity in drought-prone environments. gcp partners draw on plant diversity and new technolog...researchers at both the global and regional level. gcp is a program of the Consultative Group on Internat...

Kendle Executive Dennis Hurley, DrSc to Present Keynote Address at DIA Latin American Congress 2007

...linical trials in Latin America include: - Solid regulatory framework with predictable timelines and reliable processes in line with international gcp guidelines - Access to nearly 200 million pediatric patients - High quality data as confirmed by FDA and sponsor audits - Hispanic and African desc...

Good Clinical Practice Journal Awards: Winners Announced

... patients with metastatic renal cell carcinoma - Pfizer Global Research and Development Most Successful Company or Programme of the Year in Raising gcp Standards Sponsored by Trial Trove Winner - Good Clinical Data Management Practices Document - Society for Clinical Data Management Best Technolo...

Peregrine Pharmaceuticals Initiates Patient Enrollment In New Cotara(R) Brain Cancer Trial

...als with many of the investigators involved with our study." The new Cotara study is being conducted according to internationally accepted ICH gcp guidelines. ...
GCP in Medical Technology

IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP)

...cluded in the Company's applications for regulatory approval, and to review gcp compliance of the COG in terms of patient randomization and stratification,... The Company supported the COG in this effort. Following the satisfactory gcp inspection in April and the June CHMP meeting, the CHMP requested that the ...

IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following June Meeting of European Committee for Medicinal Products for Human Use (CHMP)

...andomization and stratification, overall survival data collection, and study monitoring. The Company supported the COG in this effort. Following the gcp inspection in April and the June CHMP meeting, the CHMP requested that the Company provide additional data analyses from the Phase 3 L-MTP-PE trial (I...

Eisai's Commitment to Oncology Demonstrated by Clinical Data to be Presented at ASCO Annual Meeting

...ing High- A1 dose Melphalan Prior to Stem Cell Transplant Poster 46B gcp II Inhibitor Glutamate Carboxypeptidase II May 31, 2008 Abstract No: 9558 Inhibition in Rat Models of 2:00-6:00 p.m. ...

Oxygen Relieves IBS and Constipation Symptoms in New Clinical Studies

...n, IBS, or both. The study (properly termed Clinical Trials Phase I - III for Oxy-Powder for Treating Constipation and IBS) was performed according to gcp guidelines for safety, efficacy, and tolerability in human test subjects. According to a Global Healing Center spokesperson, oxygen colon cleansing ...

Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer

... new study will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being conducted according to ICH and gcp guidelines. According to the World Health Organization, metastatic breast cancer is the most commonly diagnosed cancer in women, and is second only t...

Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India

... expected to further enhance the tumor-killing potential of Cotara. The new Cotara study is being conducted according to internationally accepted ICH gcp guidelines. About Cotara(R) Cotara is an experimental new treatment for brain cancer that links a radioactive substance designed for medical uses--a...
GCP in Medical Products

Thomson CenterWatch Pipeline Intelligence

Features:... listings) Accessible through therapeutic area or geographic location Clinical trial listings are IRB (Institutional Review Board)-approved and meet gcp (Good Clinical Practice) guidelines Access to hundreds of Research Center profiles All therapeutic areas ...
Company:Skyscape, Inc.

Thomson CenterWatch Clinical Trial Listings

Features:...listings). Accessible through therapeutic area or geographic location Clinical trial listings are IRB (Institutional Review Board)-approved and meet gcp (Good Clinical Practice) guidelines All therapeutic areas Access to hundreds of Research Center profiles Updated monthly ...
Company:Skyscape, Inc.
GCP in Biological News

Hunt for 'climate-ready' crops accelerates as organizations search seed collections worldwide

...he support of the Bill & Melinda Gates Foundation, is supporting work to probe crop collections for critical traits such as drought or heat tolerance. gcp is offering funding for scientists to use molecular mapping technology to identify the "DNA fingerprint" of the crop samples. The UN Food and Agricult...

NC State researchers find soy may aid in treating canine cancers

... a commercially available form of genistein called gcp was effective in killing canine lymphoid cells in a laboratory setting, and that gcp is "bioavailable" in canines - meaning it is absor...s hope that their findings will lead to the use of gcp for their canine patients in conjunction with trad...

Emissions rising faster this decade than last

...ide sinks such as forests and oceans. The new results were released simultaneously in Washington by Dr Canadell and in Paris by Dr Michael Raupach, gcp co-Chair and a CSIRO scientist. Dr Raupach said Australia's position remains unique as a developed country with rapidly growing emissions. "Sinc...

Growth in the global carbon budget

...hed simultaneously by Global Carbon Project co-chair Michael Raupach in France at the Paris Observatory, and in the USA at Capitol Hill, Washington by gcp Executive Director Pep Canadell. The Global Carbon Project posted the most recent figures for the worlds' carbon budget, a key to understanding the...
GCP in Biological Technology

Speid & Associates Partners With Genizon BioSciences to Reduce Attrition Rates of New Drug Compounds

...n has recruited over 47,000 subjects in 25 common diseases, which are analyzed in a unique, integrated high throughput facility that is compliant with gcp and GLP guidelines. Discoveries are translated into clinical practice through collaborative research with academic and clinical leaders. Genizon als...

Shanghai CRO Service Alliance Adds Clinical Development Capabilities

...nical studies, registration (for chemical and biological drugs, medical devices, etc.), new drug development and technology transfer, data management, gcp training, and market research. Since its founding in 2002, Tigermed has established long-term relationships with many clients in registration and clin...

Irving Dark Named Vice President of Cytel Clinical Research Services

...ness Development departments. Mr. Dark was integrally involved with Veristat's Corporate Compliance activities to ensure adherence with regulatory and gcp guidelines, and was instrumental in the company's oncology and influenza contracts, and the Acambis smallpox vaccine program. Previously, Mr. Dark h...

Chinese pharma-biotech dragon rears its head

...easure alone has significant impact on the performance of clinical trials in China in a manner consistent with world-class standards. The impact of gcp means not only the potential usability of Chinese clinical data for regulatory submissions in other countries, but the potential growth of the Contrac...
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