Friday, September 22, 2006
Alquest, a medical device focused contract research organization (CRO) based in Minneapolis, Minn., has launched services in India. The company claims to be the first such CRO to expand medical device offerings into the emerging India trials market. Medical device companies are particularly afflicted by challenging patient recruitment rates, and Alquest feels many companies will head to India to shave costs.
Clinical research in Latin America has grown significantly over the past 10 years but obstacles to continued growth still exist. In our first-ever survey of investigative sites in Latin America, we at Thomson CenterWatch found that bottlenecks at the site level continue to hinder growth of clinical research in the region as researchers strive to improve the system.
Hot Latin American Clinical Research Market Will Moderate
Helping to quell a storm of a controversy, the FDA has issued new guidelines describing the circumstances when informed consent can be waived for clinical trials in emergency or ambulatory settings. It’s a big issue. Informed consent is a ‘sacred cow’ in today’s clinical trial industry, and rightly so.
Hesperion Acquires TouchStone Research in Maryland
Peter U. Witte, former president and chief executive officer of IMFORM, a contract research organization (CRO) based in Darmstadt, Germany, was sentenced in August to four years in jail in Munich District Court for fraud, corruption, and aiding and abetting the betrayal of confidence. CW Weekly has been investigating what led up to Witte’s sentencing for several months. Witte confessed that for years he had defrauded his principal client, Japan-based pharmaceutical company Sankyo, with bills for several million euros for services supposedly performed during a drug study, according to a published report in Süddeutsche Zeitung.
Posted by: Karen E. Woodin, PhD
Well, it’s about time the FDA took a hard look at the compounding of drugs at some pharmacies. Until now, the FDA sort of looked the other way at pharmacists who custom-blended drugs from bulk ingredients. Particularly popular have been custom hormone replacement therapies or drugs that remove an ingredient that may be an allergen.