Gedeon selects Phase Forward’s Clintrial platform
Although Gedeon is primarily known for its generics portfolio, particularly in markets in central and Eastern Europe, the firm does have an innovation arm that generates around 16 per cent of its revenue each year.
At present, Gedeon has two drug candidates in Phase II trials, in partnership with Forest Laboratories and Mitsubishi Tanabe, as well as three at Phase I and 11 in preclinical development.
Under its “multi-year” deal with Phase Forward, Gedeon will use Clintrial to streamline all aspects of its trial programmes, ranging from data collection and discrepancy management to site reporting and administration.
While specifics are not being disclosed, a Phase Forward spokesperson was able to tell Outsourcing-Pharma that: “Gedeon Richter is stepping up its clinical development efforts, and wanted to ensure that it teamed up with a partner with a broad set of solutions.”
She added that: “Clintrial has been used for many years in Europe by leading organizations, and has successfully supported submissions to many international regulatory agencies, including the EMEA.”
In a press release, Gyorgy Nemeth, Gedeon’s medical director, said that the firm had opted for Clintrial after an “intense review process.”
Nemeth added that: “We know that we are collaborating with the premier technology provider for clinical trials and we look forward to garnering the benefits inherent in greater drug trial efficiencies.”
CEE trials market
Demand for treatment naïve patients and the drug industry’s desire to reduce the cost of trial programmes has seen considerable growth in the number of studies being conducted in emerging markets, including the CEE.
This expansion has begun to open up new markets for trial services providers as Phase Forward’s spokesperson explained.
“One of the emerging, high-growth areas for clinical trials is certainly CEE, with both local branches of international companies as well as many organizations that have been founded in the region. Phase Forward has a number of clients in Eastern Europe, and our base there is growing.”
She went on to say that: “CEE is a highly attractive region for running clinical trials. With a population of over 300 million, it offers a substantial pool of patients. Studies conducted there have yielded high data quality as well.
“As a result, sponsor organizations are increasingly incorporating CEE sites into their strategies for global studies. In fact, the number of clinical trials initiated in the region more than tripled from 2002 to 2007. So it is extremely important that Phase Forward have visibility and strong support for these regions.
