Clinical Trials Industry News

Copernicus Group IRB (CGIRB), a leading independent institutional review board, has been named a finalist in Training magazine’s annual Top 125, which ranks companies’ excellence in employer-sponsored training and development programs.

EXTON, PA – Frontage Laboratories, Inc., a global pharmaceutical contract research organization (CRO) has just completed a successful quality audit that certifies regulatory compliance and enables it to provide clinical trial materials for a client’s upcoming European Union (EU) clinical study.

Friday, 09 September 2011 09:04

How Biomet Prepares for an FDA Audit

In a few short weeks, Marcus Evans is hosting its inaugural Clinical Trials for Medical Devices Conference in Chicago.

Our #MedDevice guest this week, Keli Hankee, Manager of Clinical Affairs for Biomet Orthopedics, is a featured speaker. Keli will discuss FDA audits and will advise medical device marketing companies how to prepare for them.

Click here to read more from the featured speaker

Thursday, 21 July 2011 12:31

QIAGEN launches Multiplex PCR Plus Kit

QIAGEN launches the Multiplex PCR Plus Kit, designed for rapid and sensitive multiplex PCR that allows researchers to amplify several targets in one PCR run. The kit provides fast reaction times and comes with a pre-optimized protocol, eliminating the need for optimization and delivering reliable results on the first attempt.

Vince & Associates Clinical Research, a leading provider of early development clinical trials to the global biopharmaceutical industry announces the opening of their new, dedicated Neuropsychiatric Research Center in Overland Park, KS.

2011) Worldwide Clinical Trials Inc., a leading, global provider of clinical research services, and Thomas Jefferson University’s School of Population Health (JSPH), under the direction of David B. Nash, MD, MBA, today announced that they have entered into an alliance to provide pharmaceutical and biotechnology clients with a broad range of outcomes research services including comparative effectiveness, burden of illness, and quality of life studies.

Harvard Apparatus, has just released the NEW Pump 11 Elite Nanomite. This Syringe Pump is exceptionally small making it perfect for space limited or remote applications.

Clearstone Central Laboratories, a leading global provider of central laboratory services for late-stage clinical trials, announced that business analytics software giant SAS® has recently published a customer success story that features the extensive history between the two companies working alongside to accelerate clinical trails with clean, on-time data.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Keio Center for Clinical Research (CCR), one of Japan’s two centers of excellence promoting global clinical research, has chosen to standardize on Medidata Rave® as its electronic data capture (EDC) and clinical data management (CDM) solution.

Keio CCR was founded in 2006 as an academic research organization within Keio University School of Medicine under the auspices of the Ministry of Health, Labor and Welfare (MHLW) to assume a leading role in the national improvement of clinical trial infrastructure. Designated by the MHLW in 2009 as one of only two centers of excellence to promote global clinical research, Keio CCR plans and supports investigator-initiated, non-NDA clinical trials and observational clinical research, as well as industry-sponsored translational research, registration trials and post-marketing studies.

“Medidata Rave will be key to supporting our strategy of facilitating high-quality clinical research while looking to deliver optimum treatments and improve patient welfare,” said Keio University Center for Clinical Research Professor Yuji Sato M.D., Ph.D.

Keio CCR is upgrading its EDC solution in order to continue to expand, accelerate and improve the quality of its multinational and multicenter clinical studies. Medidata Rave’s scalable, investigator-friendly system, which was originally developed for academic clinical trials, will enable Keio CCR to continue to grow its clinical research capabilities.

Academic research centers, government agencies and other non-profit organizations in all geographies are increasingly selecting Medidata Rave for their clinical trial needs based on Rave’s advanced technology and configurability for any phase, size or therapeutic area trial, as well as Medidata’s customer-centric approach and knowledge transfer program.

“Keio Center for Clinical Research is one of the most well-respected and innovative academic institutions in Japan, and we are excited to help them expand their global clinical program,” said Tarek Sherif, CEO, Medidata Solutions. “Keio’s selection of Medidata Rave is further proof of our ability to understand and deliver solutions that overcome the specific challenges faced by academic research institutions around the world.”

About Keio Center for Clinical Research
Established by Keio University School of Medicine in 2006, Keio Center for Clinical Research(Keio CCR) is a unique academic research organization whose core mission is to facilitate high quality clinical research with the ultimate aim of achieving the highest level of treatment and patient welfare. Toward this goal, we provide comprehensive support to investigators, research subjects, and research sponsors worldwide. For more information, visit www.ccr.med.keio.ac.jp/english.

About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers’ clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata’s advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidata™), randomization and trial supply management (Medidata Balance™), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

Amid concerns over recent research highlighting that clinical trial participation among Hispanics and Latinos is disproportionately low compared to their percentage of the U.S. population, community and industry health care leaders will come together Feb. 12 in Dallas to participate in Todos Juntos por la Salud (All Together for Health), a forum hosted by global patient recruitment and retention company MMG.

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