Study Conduct

CenterWatch Monthly August 2010

Wednesday, August 4, 2010 09:18 AM

Spike in Warning Letters Sends Tremors Through Industry

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Duke puts PI on leave, suspends enrollment in three studies

Monday, August 2, 2010 08:16 AM

A high-profile principal investigator in oncology at Duke University has been placed on administrative leave while the university investigates whether he lied about Rhodes Scholar status on several grant applications. The university has also suspended patient enrollment in three trials he was involved in. 

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Bostwick in partnership with American International Biotechnology

Thursday, July 29, 2010 08:04 AM

Bostwick Scientific, the clinical trials division of Bostwick Laboratories, a global central anatomic pathology laboratory, announced a partnership with American International Biotechnology Services (AIBioTech.)

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Survey: Researchers Value Training

Wednesday, July 21, 2010 08:58 AM

ePharmaSolutions, a Philadelphia, Pa.-based provider of clinical research services, has completed a research survey of over 205 clinical researchers in 18 countries who administer psychometric rating scales to measure the improvement or worsening of symptoms in psychiatric and neurologic clinical trials. Survey highlights: 82% prefer to be trained by a scale author or someone expert in the field, and 90% feel interview skills training prior to site activation helps improve the ability to accurately rate subjects. “Some of the results were quite fascinating and provide much better insight into the global needs of site raters,” said Dr. Theresa Bromley, ePharmaSolutions’ associate director of rater services. The company conducts several research surveys with investigative sites every year to help improve site adoption of its technologies and services. It provides niche clinical services to help improve the way sites are selected, trained, activated and supported to commence clinical trials and meet enrollment goals. ePharmaSolutions has activated and trained more than 185,000 clinical researchers in 107 countries for the top 20 pharmaceutical companies around the world.

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Partnership Assists Patient Recruitment

Tuesday, July 20, 2010 09:01 AM

Healthcare software company Bio-Optronics and Clinical Research Associates (CRA) have developed a strategic relationship to provide a solution for a clinical research site’s patient recruitment needs, which couples Bio-Optronics’ Clinical Conductor Clinical Trial Management System (CTMS) and Clinical Research Associates’ patient recruitment offerings. Clinical Conductor CTMS is an enterprise workflow system for organizing the daily activities involving clinical research. Users can automate their regular routine to track the necessary metrics to maintain a viable research business, create efficiencies to take on more research with the same personnel, negotiate contracts, and efficiently recruit patients. “More sites have been proactively coming to us looking for ways to recruit faster, run trials more effectively, reduce costs, and be more marketable to sponsors,” Bio-Optronics Vice President Maria Durkin said. Clinical Conductor allows sites to leverage data about protocols and patients and provides the ability to quickly identify potential study subjects within an existing patient database. CRA specializes in patient recruitment and appointment scheduling for the clinical research industry.

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Saint Joseph’s Opens Phase I Unit in Atlanta

Tuesday, July 20, 2010 08:54 AM

Saint Joseph’s Translational Research Institute (SJTRI) has opened a new 18-bed phase I unit on the campus of Saint Joseph’s Hospital in Atlanta to focus on cardiovascular, gastrointestinal and orthopedic studies.

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CRO Quintiles Opens First Prime Site in Asia

Wednesday, July 14, 2010 07:30 AM

Global CRO Quintiles announced a strategic alliance agreement with the University Malaya Medical Centre (UMMC) in Malaysia as part of its Prime Site program, an initiative focused on accelerating the development of new and more effective medicines.

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Synexus Expands Operations in Poland

Wednesday, July 7, 2010 08:45 AM

Synexus, an international recruiter and operator of clinical trials, is expanding its operations in Gdynia, Poland. It has also recently increased the capacity of its original center in Wroclaw. The new dedicated research center in Gdynia will have the capacity for four full-time investigators and will include a wide range of diagnostic instruments to cover Synexus’ expanding therapy area coverage. Dr. Radoslaw Janiak, Synexus Country Manager for Poland, said, “Being part of Synexus’ worldwide operations means that we are increasingly involved in large global clinical trials. We are able to recruit the right numbers of patients within the right time frame, and that’s exactly what sponsors are looking for. We are seeing considerable interest from a number of leading Pharmas and CROs who are keen on the developments we have under way to increase our capacity here.” Manchester, England-based Synexus has been operating in Poland since 2006 and expanded its operations there in 2009 when it acquired three new dedicated research centers in Warsaw, Gdynia and Katowice, following its takeover of CLCC.

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Doctor Sentenced to Six Months for Faking Study Results

Wednesday, July 7, 2010 07:57 AM

Scott Reuben, the Massachusetts doctor dubbed the medical equivalent of Bernie Madoff by Scientific American, was sentenced to six months in federal prison on June 24. His crime: faking favorable painkiller study results. Reuben pleaded guilty to one count of health care fraud in February.

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CenterWatch Monthly July 2010

Tuesday, July 6, 2010 08:06 AM

Sponsor Spend on Investigator Grants Decelerating

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