Theorem Clinical Research

Articles Published in 2010

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

Tuesday, August 31, 2010 08:00 AM

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.

More... »


Parexel introduces temperature control process

Monday, August 30, 2010 09:02 AM

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.

More... »


Competitors MDCI and CDSS form cross-continental CRO partnership

Monday, August 30, 2010 08:48 AM

U.S.-based Medical Device Consultants (MDCI), which provides contract research and regulatory consulting services to the medical device industry, has formed a strategic partnership with a former competitor, U.K.-based contract research organization (CRO) Clinical Development & Support Services (CDSS).

More... »

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.

More... »

Merck partners with Alectos to develop new type of Alzheimer’s treatment

Monday, August 23, 2010 08:00 AM

Merck has launched a research partnership with Alectos Therapeutics, a Vancouver-based biopharmaceutical company, to develop drugs to fight Alzheimer’s Disease based on an enzyme believed to be involved in the development of the disease and potentially other disorders.

More... »

Medco Health Solutions to acquire United BioSource in $730 million all-cash deal

Monday, August 23, 2010 07:00 AM

United BioSource (UBC), a pharmaceutical services company that specializes in post-approval drug research, has agreed to be bought by Medco Health Solutions for $730 million in an all-cash deal as part of the pharmacy-benefit management (PBM) company’s strategy to expand beyond its core business and promote medical treatment based on research evidence.

More... »

ClinTec partners with Elephant Capital for Asia Pacific expansion

Thursday, August 19, 2010 10:47 AM

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.

More... »

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.

More... »

Pharmacy benefits manager Medco Health Solutions buys UBC in $730 million all-cash deal

Monday, August 16, 2010 12:52 PM

Medco Health Solutions, the largest pharmacy benefits manager by revenue in the U.S., has agreed to buy closely held United BioSource Corp. (UBC) for $730 million in an all-cash deal.

More... »

Investors to roll three acquisitions into one adaptive trials CRO

Monday, August 16, 2010 08:45 AM

More proof that the markets are improving: equity investors the Halifax Group and SV Life Sciences have acquired three companies that they will roll up into one, yet-to-be-named, adaptive trials-focused, CRO-like entity.

More... »

`
CenterWatch Data Library
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

September 29

WCG sees ePharmaSolutions’ clinical trial portal as the next step in the data evolution, company mission

Cutting-edge advertising can ‘break through the clutter’ for successful patient recruitment

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

September

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

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

August

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

Already a subscriber?
Log in to your digital subscription.

Purchase the August issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs