Scope of Services

CTC Innsbruck is available as a partner for consultation, planning, and the conduct of clinical studies. Within the framework of a personal consultation, we are able to address your specific requirements in a targeted manner.

Our services include:

Quality Management

As a Clinical Trial Center (CTC), we are committed to Good Clinical Practice (GCP).

In order to comply with national and international regulatory requirements, the KKS operates a Quality Management System (QMS) with the aim of:

• ensuring patient safety, and
• safeguarding data integrity.

For reports or inquiries, please contact:
kks-qualitaetsmanagement@i-med.ac.at.

Pharmacovigilance / Medical Device Vigilance

Pharmacovigilance (PV) and Medical Device Vigilance (MDV) encompass all activities aimed at ensuring patient safety in clinical trials of medicinal products and medical devices. This includes the collection of all adverse events, their assessment and reporting to regulatory authorities, as well as their continuous analysis to evaluate the benefit–risk balance of the study.

We provide the following services:

• Support in the preparation of documents (safety section of the study protocol, CRF, periodic safety reports, final reports)
• Provision of all required forms (AE log, SAE report, sponsor assessment, etc.)
• Recording of all adverse events in a safety database
• Management of the SAE assessment process
• Analysis of all events for periodic benefit–risk evaluation of the clinical trial
• Reporting of SUSARs (PV) and SAEs/SADEs (MDV) to regulatory authorities and ethics committees

For reports or inquiries, please contact:
mui-vigilance@i-med.ac.at.

Clincal Research Management

Consulting

Planning a clinical study? The KKS Innsbruck offers a free initial consultation. We support you in all aspects of study management—from classifying your project and identifying required documents and approvals to budget planning.

Schedule your non-binding initial meeting by email:
kks-innsbruck@i-med.ac.at.

Medical Writing

By arrangement, we prepare key study documents for you—from study protocols and CRFs to informed consent forms, patient diaries, and manuals.

Monitoring

KKS Innsbruck supports studies of all kinds with a risk-based monitoring approach. Our monitors oversee your study sites on site across the German-speaking region and, as needed, in other European countries.

Datamanagement

Our data management team provides end-to-end support—from consulting and protocol review (including identification of relevant data points) through ICH-GCP–compliant development or review of CRFs and the preparation of all data management documentation, to database build, data entry, and preparation for statistical analysis. We provide subject-matter support throughout the entire study duration and train your study team in CRF handling directly at the site.

For reports or inquiries, please contact:
kks-datenmanagement@i-med.ac.at.

Regulatory Affairs

We guide you through the entire regulatory approval process and, upon request, handle the complete submission. From the initial concept to project execution, we are a reliable partner at every step.

For MUI-sponsored studies, submissions for clinical trials of medicinal products via CTIS are handled by the study managers at KKS.

Project Management for Clinical Trials

KKS Innsbruck can take on full project management of your clinical study or defined work packages. We advise on regulatory requirements, proactively support your study sites, and prepare budgets for investigator-initiated trials. We also offer study-specific trainings, ICH-GCP–compliant quality management, manage investigational product and sample logistics, and support study planning—from protocol development to organizing national and international investigators’ meetings. During conduct, we obtain required national approvals (e.g., radiation protection), create SOPs and investigator site files, maintain the TMF, and support you with the final study report.

For inquiries, please contact:
kks-regulatory@i-med.ac.at.

Delegation Agreement and Sponsor Oversight

The decision on whether MUI assumes the sponsor role lies solely with the Rectorate—for trials of medicinal products, medical devices, and in vitro diagnostics, as well as for non-interventional studies (per AMG, MPG). Applications are submitted via KKS in the form of a delegation agreement, which defines sponsor obligations and appoints a study-specific sponsor representative.

One Stop Shop = Single Solution for Clinical Trial Site Agreements

For the conduct of a clinical study at the A.ö. Landeskrankenhaus (University Hospitals) Innsbruck, only a Clinical Trial Agreement (CTA) has been required since 01 July 2024. All services are budgeted within the CTA.

Specialised and trained start-up coordinators provide support from contract negotiation and budget preparation — ensuring compliance with applicable funding guidelines, EU State aid law, and Fair Market Value pricing — through to study initiation. In addition, they ensure smooth invoicing and financial management throughout the study lifecycle with the respective contractual partner.

For reports or inquiries, please contact:
mui-startup@i-med.ac.at.

For services provided by TK or by the hospital pharmacy, please contact:
mui-kostenersatzTK@i-med.ac.at.

Study Coordination

Our study coordinators play a central role in the accurate conduct of clinical trials (medicinal products and medical devices). Their responsibilities include:

• Support in:
  • Study start-up process
  • Ethics submission
  • Power Trials
  • Annual reporting
  • Study close-out
  • Clinical trial registries
• Scheduling and support during study visits
• Documentation and management of source data
• Organisation of sample handling in accordance with the laboratory manual, including shipment (all study coordinators hold an IATA certification)
• Acting as contact persons for national and international regulatory requirements

Insurance

For clinical studies, the conclusion and provision of no-fault personal injury insurance as well as medical liability and legal protection insurance may be required. Academic, multicentre studies may be covered under the MUI framework insurance agreement.

For insurance inquiries, please contact:
kks-versicherung@i-med.ac.at

OKIDS

As part of the Child Health Strategy of the Austrian Federal Ministry of Health (BMG), the improvement of paediatric medicinal products was defined as a key objective and implemented within Working Group 6 of the Child Health Dialogue.

The Austrian clinical trial network for medicinal products and therapies, “OKIDS”, serves as a competent partner and service provider for universities, specialised centres, and the pharmaceutical industry. By consolidating expertise, infrastructure, and resources, OKIDS enables the efficient planning and conduct of academic and industry-sponsored clinical studies in paediatric populations. In doing so, it contributes to the strengthening of clinical research and the generation of robust evidence on the safety and efficacy of medicinal products in children.

Further information is available here.