Study Conduct

The CenterWatch Monthly October 2010

Friday, October 1, 2010 09:04 AM

Anticipating disruptions from sponsor M&As and consolidations

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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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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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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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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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Synexus sees clinical trials rise 25% in Hungary

Tuesday, August 24, 2010 07:00 AM

Synexus’ clinical trials activity in Hungary increased by 25% during the first half of 2010. The company’s Dedicated Research Centre has been operating in Hungary since 2006 and has become one of the company’s most successful CEE sites. The Budapest-based operation has been involved in more than 74 trials since being acquired by Synexus, and has randomized over 600 patients. Dr Erika Nemeth, Synexus’ country manager in Hungary, said the trend of more clinical trials being conducted in Hungary is set to continue: “The high standards of medical and research & development expertise in Hungary has resulted in high levels of participation in clinical trials and means that pharma and biotech companies remain keen to include Hungary as part of their global clinical trial programs.” The prevalence of chronic conditions including CVD and COPD among the Hungarian population, together with little preventative healthcare and healthcare education, means the treatment naïve population remains substantial and therefore attractive for clinical trials. Also, the pharmaceutical market in Hungary is set to increase significantly in the coming decade, encouraging the major players to establish a stronger and more proactive presence there before their new drugs come to market. Synexus CEO Michael Fort said the productivity of investigators, the attractive overhead costs and the world-renowned medical expertise and innovation in Hungary make it one of his company’s key areas for future development.

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ActivMed opens N.H. research center

Tuesday, August 17, 2010 09:05 AM

ActivMed Practices & Research, which runs a clinical research center in Northern Massachusetts, has opened a second site in Rochester, N.H., a city where patient access to clinical trials could help raise the level of healthcare in the community by offering higher standards of treatment and access to cutting-edge therapies.

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Lambda acquires Biovail’s early phase unit

Tuesday, August 10, 2010 07:32 AM

As part of transforming from a maker of primarily generic drugs to a maker of innovator products, and also as part of its impending merger with Aliso Viejo, Calif.-based Valeant, Toronto-based Biovail has sold its 194-bed, phase I/bioanalystics lab to Indian CRO Lambda Therapeutic Research for $6 million.

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Alzheimer’s Association launches TrialMatch

Monday, August 9, 2010 07:25 AM

In an effort to help fulfill an urgent need for clinical trials patients, the
Alzheimer’s Association has spent $1.2 million to create TrialMatch. Launched in mid-July, the phone and online system aims to match Alzheimer’s patients and their caregivers to ongoing clinical trials.

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