Karolinska Trial Alliance (KTA)

Karolinska Trial Alliance – regional “hub” in the Stockholm region

Karolinska Trial Alliance (KTA) is a professional Clinical Research Center at Karolinska University Hospital in Stockholm. KTA is supported by Stockholm County Council (SLL) and the Karolinska Institute (KI). KTA has specialized and high level of knowledge and gives hands-on support for clinical research to optimize the process of conducting clinical trials.

KTA conducts clinical trials and support covering all phases (0-IV). KTA has the possibility to cooperate with hospitals and clinics within the entire Stockholm region which gives access to the extensive resources of one of Europe’s leading university hospitals. This includes access to various clinics, intensive care units, radiology departments, laboratories, Vecura (cell and gene production) biobanks as well as to the Karolinska Institute’s world-leading researchers.

The collaboration with the industry range from a single point of contact to long term cooperation and agreements. KTA now also has a regional responsibility to be available and provide services, administrative and/or infrastructural, for all actors working with clinical research in the Stockholm County Council. KTA is one of six regional hubs in Sweden working for national coordination within the area of clinical research in order to improve the condition for and increase clinical research nationally.

KTA consists of three units each with a track record of clinical trials in various medical areas, supporting and conducting clinical studies in different phases in cooperation with several different sponsors, researchers and physicians.

Covering the complete clinical trial process

KTA streamlines the clinical trial process in order to reduce time and cost of clinical research. The business model allows clients to choose and mix services accord­ing to their specific needs or alternatively choose a complete study concept package in which KTA is involved from start to finish.

KTA Phase 1 Unit conducts clinical trials for the pharmaceutical/medical appliance industry and for academic researchers. The Phase 1 Unit has 16 beds and experi­enced GCP-trained personnel to carry out clinical studies from first-time-in-man to proof of concept. Our core competences include first-in-man administration of investigational products including vaccines (SAD, MAD, PET, PET-CT and MRI), bioequivalence/bioavailability studies, urine catheterization studies and biopsy studies.

KTA Support provides support for clinical research for the entire Stockholm County Council. KTA Support primarily offers administra­tive and regulatory support for the implementation of academic clinical trials but also for the medical industry. The knowledge and experience within the field of clinical research is profound and wide ranging. We offer tailor-made support from the idea throughout the entire study process, specifically designed to fit our clients’ requirements.

KTA-Prim conducts open-care studies mainly in phase II-IV. The aim is to increase the number of open-care research studies performed in the Stockholm region. KTA Prim offers support for clinical trials through a modern infrastructural endorsement. That enables the open healthcare in Stockholm (SLL) to efficiently contribute in clinical trials without exploiting resources meant for routine care. The intension is to facilitate for the medical industry, for the academy and for the open care health in Stockholm to perform clinical trials as well as to provide better options for patients to participate.

Study administration

Study related administration is handled by professional and well educated staff. KTA works according to specific routines and adapted IT-solutions for optimal efficiency. The philosophy is to always keep a high level of service in all relations, i.e. human test subjects, primary health care contacts, the research team, clinics, investigators and sponsors.

Safety

KTA works according to specific standard operating procedures and efficient routines and has a dedicated person responsible for internal QA-systems.

Patient recruitment

Recruitment of human subjects is often an issue when per­forming clinical studies. KTA has a high recruitment capacity and resources to include large patient groups in trials. The methods of recruiting are customized to the specific study and target group. Recruitment is often carried out in close cooperation with the Primary Health Care, hospital clinics or other external collaboration partners.

KTA has access to more than 70% of EHR data in the open care of Stockholm County Council through a particular blinded feasibility system. The system facilitates the process of locating number of feasible subjects for each specific clinical trial.

KTA has a recruiting network of more than 40 open-care clinics and databases with a total of over 20 000 healthy volunteers and patients interested in participating in clinical trials.

For more information and contact details, please visit our website:

www.karolinskatrialalliance.se
Email: kta@karolinska.se

KTA

Karolinska University Hospital
+46(0)8 517 782 11
http://kta@karolinska.se