Theorem Clinical Research

Articles Published in 2010

Eli Lilly expands its outsourcing partnership with i3 Statprobe

Tuesday, September 28, 2010 07:40 AM

Expanding the outsourcing support of its clinical trials, Eli Lilly is transferring U.S. medical writing and biostatistical services to i3 Statprobe, a move that expands the business relationship formed between the two companies in 2008 when Lilly transferred the majority of its domestic data management activities to i3.

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PPD establishes phase I site network spanning the nation as sponsors seek quicker results

Monday, September 27, 2010 07:34 AM

PPD has set up a network of sites across North America for conducting phase I trials in patients to meet growing demand for early-phase services that can give sponsors answers about their drug candidates more quickly.

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Yale Medical Group adopts conflicts-of-interest policy

Monday, September 27, 2010 07:00 AM

Yale Medical Group, affiliated with Yale University’s medical school, has adopted a new conflicts-of-interest policy to regulate relationships between its doctor-academics and industry, Pharmalot reported. The new policy comes on the heels of a similar move at Harvard Medical School, and after a handful of other academic medical centers have reviewed their own rules. Yale Medical’s new regulations attempt to tread a fine line, designed to fend off accusations that industry money and relationships unduly influence its doctors without cutting pharma out of the equation completely. It addresses financial ties to drug and device makers; gifts, meals and other goodies from industry; ghostwriting; samples; consulting and continuing medical education. According to Pharmalot, drug sales reps bear the brunt of the rules; they’ll be allowed to visit only by invitation and with an appointment. Companies can still sponsor CME programs and provide meals during CME events. “We wanted to upgrade the guidelines to a full-blown policy so that faculty and others understand that these are no longer electives, because the landscape has changed,” CEO David Leffell said. The Yale Medical Group is staffed by roughly 800 academic physicians from the Yale School of Medicine; it is not a separate practice or foundation. The move reflects ongoing debate over the interactions between academics and drug and device makers. The National Institutes of Health has proposed new conflict rules for researchers. “Our view is that we continue to respect the role the pharmaceutical industry plays in contributing to and investing in the health of people,” Leffell said.

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Chicago HIV researcher ‘vindicated’ by FDA in clinical trial fraud case

Tuesday, September 21, 2010 07:27 AM

Daniel Berger is a happy man. The FDA has ruled that the Chicago internist and thought leader in the area of HIV can continue conducting clinical trials without any restrictions, despite evidence that his clinic submitted bogus data along with failing to perform basic tests including physical exams and electrocardiograms during one particular trial. Additionally, 200 tablets of the investigational drug went missing at his clinic during that trial.

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Four clinical research firms become one global services organization to target niche areas

Monday, September 20, 2010 07:18 AM

Four small and mid-sized clinical research service companies—Averion International, Trio Clinical Research, Fulcrum Pharma and Clin-Research/ADDPLAN—have merged into one global biopharmaceutical and medical device development services organization that will focus on niche areas, including adaptive trials and new technologies, which can help sponsors make decisions about their drug candidates faster.

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Fortune ranking of fastest-growing companies illustrates the cyclical performance of CRO sector

Tuesday, September 14, 2010 07:53 AM

Fortune’s recent release of its 2010 list of 100 fastest-growing companies illustrates how sectors that perform in cycles, such as CROs, can either benefit or lose out when measured by a snapshot in time.

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Report: Sponsors must consider patient motivation, partner with CROs for successful trial recruiting

Monday, September 13, 2010 09:49 AM

Drug sponsors need a better understanding of the factors that motivate patients to participate in clinical trials in order to design protocols that can help meet recruitment targets, according to a new report by the consulting firm Cutting Edge Information.

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New index shows CROs far outpacing pharma in hiring

Tuesday, September 7, 2010 07:15 AM

CROs are hiring exponentially more people than pharmaceutical companies or medical device makers, according to the brand-new Global Life Science Hiring Index produced by boutique talent management firm ZRG Partners. For the second quarter of 2010, the index showed that the category of outsourcing and services (mostly CROs) did a whopping 500% more hiring than pharma companies and 250% more than medical device and supply firms.

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MediciGlobal’s L2FU tracks down, contacts missing clinical trials patients

Tuesday, September 7, 2010 07:08 AM

In the clinical trials industry, P.I. stands for principal investigator. But for MediciGlobal’s new subsidiary L2FU, it could also stand for “private investigator,” since its mission is to track down patients lost to follow up (commonly shortened to “L2FU”).

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CenterWatch Monthly September 2010

Wednesday, September 1, 2010 11:31 AM

"Sunshine law" puts cloud of concern over sponsors, sites

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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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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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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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