Theorem Clinical Research

Emerging Markets

Florida site group goes global with Panama City office

Monday, January 3, 2011 07:00 AM

Sponsors and CROs have gone international. Are sites next?

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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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PPD Opens CRO’s Largest Safety Center in Bulgaria

Friday, May 7, 2010 08:25 AM

Wilmington, N.C.-based PPD opened a pharmacovigilance and medical communications center in Sofia, Bulgaria, in response to growing client demand for drug safety, medical information and medical writing services in the region. This new facility is PPD’s largest safety center and its third European hub for medical communications contact center services. The company also has centers in Athlone, Ireland, and Stockholm, Sweden.

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Trial Registration Becomes Mandatory in India

Wednesday, June 17, 2009 07:40 AM

All companies conducting clinical trials in India must now register those trials in a clinical trial registry set up by the Indian Council of Medical Research (ICMR).

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Is India Ready For Phase I Studies?

Tuesday, August 15, 2006 08:32 AM

India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer - and others would agree - is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies...

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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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The CenterWatch Monthly


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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