KKS offers guidance, planning and support in individual sub-areas or even complete management of a clinical trial.
Sub-areas include e.g. monitoring, compiling study documentation or submission to Ethics Committees and authorities. The offering will be tailored to your individual requirements in a personal consultation.
KKS's consultancy offering covers all areas of clinical trial management.
We offer a personal consultation by prior appointment available from: kks@meduniwien.ac.at or +43 (0)1 40160-25176.
We will be happy to help you with any other services or provide a non-binding cost proposal!
KKS offers monitoring as a stand-alone service or in combination with project management.
The extend of monitoring will be established individually.
According to Austrian law (Arzneimittelgesetz or Medizinproduktegesetz) a clinical trial may only be conducted after the approval of the responsible authorities as well as in accordance with EU-law.
KKS provides consultation during the regulatory approval process or can take over the whole submission process, depending on the agreement.
KKS will gladly take over the entire project management of clinical trials or just specific sub-areas, as required.
In addition to advising on study planning, this can also include assisting with or taking over the following areas:
- consulting and support with compliance with legal requirements
- proactive supervision of the study sites
- various trainings (eg. eCRF)
- ICH-GCP-compliant monitoring for Quality Control
KKS offers ICH-GCP-compliant data management by using the electronic data capture system Clinspire®.
We can offer you the following services:
- consulting
- design and creation of electronic Case Report Forms (eCRF)
- preparation of data for statistical analysis
- ongoing support during the trial
- MedDRA Coding
KKS offers Medical Writing in accordance with ICH Guidelines. This includes the preparation of reports and documents for your clinical study, from the planning phase to the end of the study.
This includes inter alia:
- study protocol or Investigation Plan
- patient information and consent forms
- study specific documentation in line with amendments (Authorization/Drug Accountability/Temperature Logs etc.)
- interim and safety reports
- final report/study report
Pharmacovigilance in clinical trials refers to processes that provide ongoing monitoring of the safety of study volunteers during the course of a clinical study involving drugs.
Amongst other things, pharmacovigilance includes the timely recording and assessment of incidents and adverse events. If these events affect the risk-benefit ratio of the study, Ethics Committees and authorities must be notified.
Our pharmacovigilance service offering includes:
- SAE-management (2nd assessment and reporting to sponsors)
- SUSAR reporting to authorities and Ethics Committees
- annual safety reports (Development Safety Update Reports - DSUR)
- providing appropriate forms and templates
In order to encourage academic clinical research at the Medical University of Vienna, a cost-effective blanket insurance policy has been negotiated with Zürich Insurance. This covers all clinical trials of pharmaceuticals or medical devices, a combination of both or even basic research studies. Individual study insurances, the issue of policies and contacts with Zürich Insurance are handled centrally via KKS.
KKS will provide the appropriate form.
Queries and applications are handled via:
versicherung-studien@meduniwien.ac.at