IMSART - Institute for musculoskeletal analysis, research and therapy

Introduction

IMSART is an independent Research Institute specialising in orthopaedics. IMSART is focused on the central co-ordination and logistics of orthopaedic related clinical research projects, including medical devices and new surgical / pain management / rehabilitation techniques as well as phase II, III and IV studies of new drugs.

IMSART differs from a conventional CRO as being a catalyst to industry and investigators in clinical practice in the setting up of and the supporting of clinical studies and in the setting up and management of training courses. In this role, IMSART focuses on meeting quality standards, budget and time constraints. The ultimate objective is to help customers obtain product approval and achieve a marketable product and market acceptance. Special emphasis is giving on hands – on courses, cadaver courses, surgeon training, onsite surgical support and, if needed, cell studies, biomechanical study and animal study support.

 
Investigator Network

IMSART has a network of leading orthopaedic surgeons and centres world-wide with emphasis on Europe and Asia. These sites offer high quality data and are experienced in working according to GCP standards and IMSART Standard Operating Procedures (SOPs). Having established this network, IMSART is able to reduce the time for site selection to a minimum without compromising on the quality and patient volume of participating sites. In addition, the highly motivated and well-known investigators ensure the shortest possible patient enrolment time.

 
Focus on Spine and Sports Medicine

As a result of the strong focus on spine and sports medicine, IMSART employees have expertise both in running clinical trials and in top level surgery as well as pain management and rehabilitation. IMSART is able to develop the design of Protocols and Case Report Forms according to the clinical practice setting and make the conduct of the trial efficient and of high quality.

 
Service

In the field of orthopaedics IMSART offers a package of trial-related services, from protocol design to assists in operations, and medical writing.

In short: the experience in and the focus on spine / sports medicine combined with the investigator network and project-oriented organisation make IMSART the logical partner for new projects, emerging technologies, new medical devices and much more.

 
Development and teaching

IMSART offers assistance in the development of new products / techniques by organising cell studies, animal studies, biomechanical and FEA studies. Those studies are conducted at independent high profile research centres world – wide adhering to CE and FDA standards. The centres are recruited depending on specific issues and study needs whilst always focusing on an optimal standard or research within a specified time frame.

Emerging projects can be reviewed and assessed by orthopaedic surgeons, traumatologists and neurosurgeons as well as pain specialists in order to provide early interdisciplinary insight. IMSART is also able to provide experienced spine / sports medicine specialists to create and conduct surgical courses with the assistance of international well renowned anatomy and training labs. Furthermore those specialists can, once trained by the sponsor, operate themselves or assist in various hospitals recruited for the study.

 
Mission

IMSART offers opinion-leader expertise, innovative insight and interdisciplinary assessment and high-quality CRO services in orthopaedics and related fields at competitive prices and within pre-defined timelines.

 
Vision

IMSART has gathered highly experienced specialists from different surgical and non – surgical specialities in order to supply of expertise and services in studies in Spine / sports medicine, especially in the device and emerging technology area and to a somewhat lesser extent also in the pharmaceutical area. To strengthen our position further, we try to fine-tune the group structure and culture to meet the needs of our customers.

Being able to provide access to knowledgeable opinion leaders helps optimise the development strategies of our clients. The resulting high-quality project plans shorten the development timelines and decrease the costs.
Our close collaboration with knowledgeable opinion leaders allows us to design and run high-quality, fast-recruiting and cost-effective trials.

IMSART strives at being at the leading edge of spine / sports medicine related techniques and makes a lot of effort to develop and teach new techniques. With the development and teaching of even newer invasive and non-invasive techniques, IMSART wants to remain one of the leading providers in the field.
For very large scale studies IMSART works together with partners in the field of study monitoring.

 
Trial design

The key factor in achieving a successful clinical trial is to have a well-prepared, consistent Trial Design, Protocol and Case Report Form (CRF).

One of the advantages of working with IMSART in trials is that IMSART not only has extensive experience in clinical trials but also clinical and academic expertise in the field of orthopaedics. This gives the sponsor maximum efficiency in the trial preparation phase and an excellent start to the clinical trial itself.

 
Design or Review

The services requested from IMSART differ from trial to trial. Therefore, all IMSART project proposals are tailor-made. The same applies to trial design, the Protocol and the Case Report Form (CRF). Although IMSART is experienced in designing Protocols and CRFs from scratch, projects are also run with pre-designed Protocols and CRFs from the sponsor. In this case, documents are simply reviewed for consistency with the activities that will be performed by IMSART. Furthermore ethical committee submission forms can be individually adapted and supplied in order to assure rapid progression through ethical boards.

 
Project Management

Good Project Management is essential for running Clinical Trials efficiently. A few important Project Management activities are listed on this page.

 
Co-ordination

Conducting clinical trials is people business. Regardless of whether the trial involves 50 or 10,000 patients, as soon as a sponsor decides to work with IMSART one of the experienced Clinical Trial Managers will be appointed as Project Manager. The appointed Clinical Trial Manager sets up an IMSART project team and co-ordinates all contact between the investigators, committee members, representatives from the sponsor and Clinical Research Associates (CRAs) in a smooth and client friendly way. He or she is also responsible for all agreements made with the sponsor on timelines, quality and costs of the trial.

 
Site Selection

In site selection, only a few factors are really important: whether it can be done quickly, and whether the sites have the right requirements (high quality, the requested patient volume, necessary equipment and expertise, and motivated investigators). IMSART has close contact with leading centres world-wide ensuring quick site selection without compromising quality.

 
Data Management

The valuables of a clinical trial are the data gathered. Handling has to be done by well-trained and organised specialists of IMSART.

 
Complete Serious Adverse Event (SAE) Report

IMSART reports all SAEs to the sponsor within 24 hours or on the next working day enabling the sponsor to notify the competent authorities within the stipulated time window. If requested by the sponsor, IMSART will collect all event-related documents, write event narratives and provide these to the sponsor.

 
Remote Data Entry

With Remote Data Entry IMSART provides a way of communicating with those involved in a modern and very direct way. For example, by collecting the data related to several clinical trials via the internet the process of collecting data becomes much faster than by the traditional method of data collection thereby providing user-friendly interfaces. Spine data will be entered in the Spine Tango System of the European Spine Society starting in 2010. This system is specialised in data gathering, interpretation and calculation of representative endpoints.

 
Biostatistics

IMSART is working together with one of the leading statistical institutes in Europe which has extensive experience in the analysis of data from clinical trials, especially in advanced statistical methods for interim analysis, final analysis and stopping rules.

The statistical staff is involved in trial design, Protocol and Case Report Form development, and the design of data management. During data collection programmes are prepared for final statistical data analysis to ensure rapid reporting of the trial. The amount and level of statistical analysis varies from trial to trial, depending on the requests of the sponsor and the investigators. The staff at IMSART collaborates closely with the sponsors and Steering Committee to perform interim and final statistical analyses. Often the scientific interest continues beyond the initial presentation of the data. Additional analyses can be conducted either by IMSART or by individual investigators using the trial database. This may lead to continuing publicity, even years after completion of the trial.

Other statistical services include: Pooled analyses in which databases from different trials can be combined to conduct additional analyses, and Health Economics and Quality of Life Analyses using the Euroqol system and SF 36 questionnaire.

 
Reimbursement and market analysis

We furthermore provide an experienced reimbursement specialist and market insight of Austria and Europe regarding coding, reimbursement and initiation of new technology.

 
Publications

For our publications, please click this link:

  

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Further Informationen

If you have any questions about the Research Institute IMSART please contact us:

Tel. +43-1-8901719 - 0
Fax +43-1-8901719 - 20

E-Mail: imsart(at)medimpuls.at