Lund, September 9th, 2009
For release 9 a.m. CET, September 9th, 2009
TFS and Karolinska University Hospital prolongs their early clinical development partnership until 2016 and expands the research facilities.
TFS Trial Form Support International (TFS) and Karolinska University Hospital has as of May 25th, 2009 prolonged their public private partnership until 2016 and expanded their early clinical research unit at Karolinska Trial Alliance (KTA) with additional 850 square meters and 16 overnight beds. The partnership comprises early clinical development with studies conducted at the integrated research unit at KTA.
The public private partnership was first signed in 2003 and has since been prolonged twice. The current prolongation signed in May 2009 is valid until 2016. The research unit has since the establishment in 2003 developed into a leading early clinical development facility in Northern Europe. The hospitalized research unit with access to special patient populations is mainly focused towards First-in-Man (FIM), Proof-of-Concept, microdosing- and imaging studies utilizing Positron Emission Tomography (PET).
“With the expansion of the facilities and the prolongation of the agreement with Karolinska University Hospital, we have now taken an important step to meet our strategic business goal in becoming the most trusted and scientifically reputed research unit in Europe. With a total number of 30 beds, we now have extended our capacity which means that we can shorten timelines for certain studies by running more studies in parallel. The expanded facility is a fully state-of-the-art equipped FIM research unit and has been designed so that it suits all different types of early clinical development studies. From basic bioequivalence studies to the more demanding FIM Multiple Ascending Dose studies”, said Mrs. Eva Lundqvist, MSc, ML, Director Academic Alliances at TFS.
Due to the increasing demand from the life science industry to outsource early clinical development studies the hospitalized research unit has been expanded with additional 850 square meters and 16 beds, now hosting a total facility area of 1 400 square meters and 30 beds, making it the largest unit in Northern Europe. The research unit was successfully inspected by the Swedish Medical Product Agency (MPA) in March 2008 and by the US Food and Drug Administration (FDA) in January 2009, fulfilling MPA and FDA requirements under the FIM-inspection program.
“This partnership has enabled TFS’s early clinical development business to grow and establish itself as one of the leading units in Europe. Furthermore it has of course added a great value both to the Karolinska University Hospital in terms of building their knowledge and experience around complex early clinical studies and to our customers seeking for first-class units with special capabilities located within a leading university hospital”, said Mr. Daniel Spasic, Chief Executive Officer at TFS.
The partnership is further an evidence for how successfully industry, healthcare and academia in Sweden can integrate and create a better and healthier life for patients in need of new innovative treatments for their diseases.
“The collaboration with a private partner gives the hospital an influx of important new medical ideas and treatments, facilitates investments and development of scientific competence. This is achieved without any financial risk for the university hospital and benefits our patients and tax payers in the end”, said Professor Pierre Lafolie, Head of Karolinska Trial Alliance at the Karolinska University Hospital.
For further information please contact:
Ms. Gordana Clavères
Marketing and Communications Assoc.