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

CTC Innsbruck offers all investigators a free initial consultation. The advisory services of CTC Innsbruck cover all areas of clinical trial management (e.g. classification of the research project, required documentation and approval steps, support with budget planning, and more). For a non-binding initial consultation, we kindly ask you to schedule an appointment in advance at kks-innsbruck@i-med.ac.at.

Medical Writing

CTC Innsbruck supports or, upon agreement, takes over the preparation of study-related documents (e.g. study protocols, case report forms, informed consent forms, patient diaries, standard operating procedures/manuals).

Monitoring

CTC Innsbruck provides monitoring services for all types of clinical studies, applying a risk-based approach. Our monitors support, among others, local study sites, sites across German-speaking countries, as well as in selected other European countries.

Datenmanagement

The following services are offered:

• Consultation
• Review of the study protocol from a data management perspective / identification of required data points
• Review and ICH-GCP compliant design of case report forms
• Preparation of data management-related documents
• Database setup and data entry
• Data preparation for statistical analysis
• Professional support throughout the entire project duration
• CRF training for the study team at the site

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

Regulatory Affairs

CTCInnsbruck offers consultation on the regulatory approval process and, upon agreement, takes over submission activities.

We are pleased to support your project from initial concept through to implementation.

Delegation Agreement and Sponsor Oversight

The assumption of the sponsor role (MUI Sponsor) for clinical trials of medicinal products, medical devices, and in vitro diagnostic medical devices, as well as non-interventional studies under the applicable legal frameworks (AMG, MPG), is subject to approval by the Rectorate. A corresponding application must be submitted via the CTC in the form of a delegation agreement.

The delegation agreement defines the transfer and allocation of mandatory sponsor responsibilities in accordance with applicable regulatory requirements and includes the appointment of a study-specific sponsor representative.

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

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.

Project Management of Clinical Studys

The CTC assumes full or partial responsibility for the project management of clinical studies.

Dies kann die Unterstützung oder Übernahme in folgenden Bereichen umfassen:

• Consulting and support in meeting regulatory requirements
• Proactive support of study sites
• Budget calculation for investigator-initiated studies
• Various training activities (study-specific training)
• ICH-GCP-compliant quality assurance processes
• Logistics of investigational medicinal products and collected samples
• Clinical study planning (e.g. support in the development of the study protocol, organisation and conduct of national and/or international investigator meetings, etc.)
• Organisational support for clinical studies (e.g. obtaining additional national approvals such as radiation protection approvals, preparation of standard operating procedures, preparation of investigator site files, etc.)
• Maintenance of the Trial Master File (TMF)
• Support in the preparation of the final study report

For reports or inquiries, please contact:
kks-regulatory@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.