August 2010

First commercial IRB opens in Indiana to fill geographic gap and attract clinical research

Tuesday, August 31, 2010

Indiana now has its first commercial Institutional Review Board (IRB). Indiana and its surrounding region, that is. Diana Caldwell and Gretchen Miller Bowker—both Eli Lilly alum and former coworkers at the regulatory compliance consultancy Safis Solutions—have launched Pearl IRB to fill what they say is the commercial IRB gap that stretches north to Minneapolis, east to Philadelphia, south to Cincinnati and west all the way to San Diego.

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Parexel introduces temperature control process

Monday, August 30, 2010

Parexel International of Boston, a global biopharmaceutical services company, has introduced an integrated temperature recording solution for study drug transportation as part of its expanded Clinical Logistics Services. Its temperature control process saves 24 to 48 hours over traditional cold chain methods in which temperature devices shipped out to investigative sites need to be transported back to a hub to be read out and analyzed before study drugs can be released for use. A central hub receives and disseminates confirmations of temperature data in real-time, allowing clinical site investigators to quickly begin using study drugs according to trial protocols. Working in cooperation with Stora Enso, a global paper, packaging and wood products company, and MediXine, specializing in multimodal communication e-services for health care and wellness, Parexel has developed a temperature recording process specifically designed and optimized for the clinical trial supply process. The packaging container for study drugs incorporates a Radio-Frequency Identification (RFID) tag for temperature recording and a dedicated compartment for a mobile phone, providing automatic tracking and remote, high-speed transmission of the complete temperature record. The RFID tag records study drug temperature at pre-defined time points, while a mobile phone application and web-based portal allow secure, controlled data transmission and access to temperature data in real-time between a central hub and an investigative site.

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Synexus sees clinical trials rise 25% in Hungary

Tuesday, August 24, 2010

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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ClinTec partners with Elephant Capital for Asia Pacific expansion

Thursday, August 19, 2010

Global CRO ClinTec International has announced a financial and strategic partnership with Elephant Capital, an AIM market-listed private equity firm.  With an investment of approximately $12.5 million, Elephant has acquired a significant minority stake in ClinTec, entering the clinical research base. ClinTec operates as a global provider of outsourcing solutions addressing the drug development lifecycle.

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ActivMed opens N.H. research center

Tuesday, August 17, 2010

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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