Crossover CRI opens a Clinical Research Unit at Doverie Hospital in Sofia, Bulgaria
ZUG, Switzerland, August 12, 2009. -- Crossover CRI AG ("Crossover"), a leading provider of clinical research support staff and services to healthcare institutions, announced that it executed a master clinical research partnership agreement with Doverie Hospital in Sofia, Bulgaria on 11 August, 2009.
Dr. Peter Keremedchiev, Executive Director of Doverie Hospital said: “Our hospital offers state-of-the-art medical care. Participating in clinical trials of international importance is a key mission of our doctors and nursing staff. Patients come to Doverie Hospital also because they know they can find access to drugs and devices which are not accessible yet outside clinical trials. Our collaboration with Crossover will boost the image of our hospital with pharmaceutical and biotechnology companies internationally.”
According to Dr. Jean-Pierre Tassignon, President & CEO of Crossover, “The Crossover Clinical Research Unit (CRU) at Doverie Hospital is the first investment of Crossover in Eastern Europe, which plays an increasingly important role in clinical research. Crossover is confident that clinical research at Doverie Hospital will develop rapidly because the global clinical research market needs elite hospitals with the equipment and talent to conduct modern clinical trials.” He sees synergistic effects with the large CRU Crossover has already set up at CHU Brugmann hospital and the HUDERF pediatric hospital in Brussels, Belgium.
The quality requirements in clinical research continue to increase. The complexity of clinical trial protocols is doubling every five years according to a study by Tufts University in the United States. Clinical trials now involve a lot of genomic and proteomic research parameters and electronic data transfer. The Crossover office in Bulgaria headed by Dr Velizar Tchernev will provide key support to the new CRU.
Crossover confirmed that it is in negotiation with other specialist hospitals in the European Union in order to continuously expand its clinical research infrastructures network.
About Doverie Hospital
The Doverie Medical Complex in Sofia, Bulgaria is located on an area of 8,000 sqm. Medical activities cover general surgery, internal medicine, urology, orthopedics, plastic surgery, gynecology, anesthesiology, gastroenterology, cardiology, nephrology, neurology and physical and rehabilitation medicine. The Hospital has a laboratory, a pharmacy, and imaging facilities. It has its own ethics committee.
About Crossover CRI AG.
Crossover CRI AG (Crossover) is currently establishing a large international network of Clinical Research Units (CRUs) at research-driven healthcare institutions. Its CRUs are located on-site at the healthcare institution to enable the collection and analysis of healthcare information both in clinical trials and epidemiology studies.
Crossover invests in establishing and staffing the CRUs that are responsible for conducting all clinical trials carried out at the selected healthcare institutions which are part of the Crossover network. The Crossover network of CRUs conducts clinical trials according to the same standards throughout the network.
Further information can be found as follows:
Contact: Dr Velizar Tchernev, International Director of Clinical Research Technology and Regional Director South-East Europe, Sofia, Bulgaria
Mobile: +359 885 59 7109
E-mail: Velizar.Tchernev@crossover-cri.com.
SOURCE Crossover CRI (=Clinical Research Infrastructures) Group.
http://www.crossover-cri.com
Fraud and misconduct in clinical trials – How pervasive in the world?
In a recent article published in the January 2009 issue of the Journal for Clinical Studies, Crossover’s President points to the alarming increase in fraud and misconduct, as well as questionable research practices worldwide in the domain of clinical research. He speculates that some of the extraordinary moneys invested in external monitoring by sponsors should be better invested in strengthening research oversight inside healthcare institutions hosting investigators. Link
HUDERF and its Crossover Clinical Research Unit join the Belgian Pediatric Clinical Research Network
The BPCRN held its first meeting on 17 December, 2008 under the chairmanship of Dr Daniel Brasseur, chairman of the new Paediatric Committee of the EMEA, and under the auspices of the Belgian Professional Association of Pediatricians as well as the Belgian Federal Agency for Medicines and Health Products. The BPCRN is the response of Belgium as a Member State of the European Union to the European Paediatric Research Network which is being instituted by EU Regulation 1901/2006 of 12 December, 2006: the EMEA is charged with creating a European-wide pediatric network capable of accommodating the numerous clinical trials which are planned as part of a growing number of PIPs being approved. A PIP is a Pediatric Investigation Plan agreed between the manufacturer of a medicinal product with a pediatric indication and EMEA. The Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) is one of the largest pediatric hospitals in Europe with 160+ beds and a new wing under construction.
The Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) joins COCRIN
Crossover announces that another hospital in Europe joins its Crossover Clinical Research Infrastructures Network (COCRIN): the Hôpital Universitaire des Enfants Reine Fabiola (HUDERF). This is one of the most advanced children hospitals in the country, with 165 beds. HUDERF is based in Brussels, Belgium. The HUDERF hospital offers a complete spectrum of diagnostic (e.g., sleep lab, neurophysiology lab, imaging department, in particular with MRI technology) and therapeutic procedures (e.g., emergency department and ICU, dialysis unit, cardiac surgery, renal transplantation, bone marrow transplantation). Another example of sophistication is its database of chronic cystic fibrosis patients. HUDERF is immediately adjacent to and connected with the maternity unit, which has over 2500 deliveries per year.
The GCP Journal 2008 Award Ceremony will take place this year on the 22nd of October again in London. Jean-Pierre Tassignon is a member of the jury and will attend the award ceremony. Link
Crossover Opens Clinical Research Unit in Brussels, Belgium
Crossover opened its first Clinical Research Unit on 1st September 2008 at the University Hospital Brugmann in Brussels. Brugmann which is situated in the north of the city, is one of the largest healthcare institutions in Belgium with over 300 doctors and has more than 850 beds across its three hospitals. This new CRU has been immediately staffed by 5 of the existing staff from the hospital who are located in a large, centrally positioned, modern and dedicated facility. The Brugmann Hospital offers outstanding clinical research facilities and access to patients and is ideally located for access to national and international road, rail and air connections. Crossover maximises the efficiency of the entire Research Team at the hospital across all phases of Clinical Trials.
The Board of Directors of the European Forum for GCP confirmed Jean-Pierre Tassignon as Chairman of the Board for another year. Jean-Pierre has chaired the EFGCP Board since 2005. Link
Nature (Vol7, pp13-14) publishes an article by Thiers et al. about “Trends in the globalization of clinical trials”. The article indicates that 66% of all clinical trial sites in the world are in North America, Europe and Oceania currently. Countries in emerging regions (Eastern Europe, Latin America, Asia, Middle East and Africa) represented only 8% of sites conducting biopharmaceutical clinical trials in 2002. In 2006, they represented 20% of site involved in biopharmaceutical trials. This shows a rapid growth of emerging countries. It is preoccupying that the average relative annual growth rate in certain countries in traditional clinical research regions is negative: -12.0% in Canada, -6.5% in the USA and -4.0% in France. In contrast, the growth rate in China, Russia and India is strongly positive (47%, 33% and 19.6%, respectively), although starting from a much lower base. Crossover interprets these data as a warning signal to healthcare institutions in traditional countries, who have to professionalize the organization of their clinical research offer and adopt sophisticated marketing techniques.