Research Support for clinical studies

Gothia Forum offers services and advice throughout the research process. We can help with individual elements or be involved in larger parts of the research project.

Our services aim to make it easier to conduct clinical studies and ensure high quality. Our employees have broad experience in clinical studies from academia, healthcare and life science companies. We collaborate nationally to be able to offer you the best possible help with your project. 

We offer research support within these areas

Grants Office

Support for competitive research proposals

Are you in the process of applying for external funding for your research project? If you are a healthcare employee in Region Västra Götaland you are welcome to contact us at VGR Grants Office for free guidance and support.

Services

We help with finding, applying for and managing external funding. Here you can get advice and tips both when applying and during ongoing projects. Our English-speaking Scientific Editor can edit your text with focus on clarity and scientific stringency.

We offer support with:

  • Scientific editing
  • Finding collaborators
  • Finding open calls and opportunities for financing
  • Budget
  • Review of formal requirements
  • Advice on performing and reporting your project

You are either the main applicant or part of a collaborative project coordinated by another organization. Your application may be directed towards funders such as the Swedish Research Council, Forte, Formas, the EU or other calls in open competition.

If you are just starting with research or would like to continue after your PhD, you can get extra support and advice with research funding and the research process. See the following links (Swedish).
För dig som vill börja forska - Sahlgrenska Universitetssjukhuset (vgregion.se)
Forskning efter disputation - Sahlgrenska Universitetssjukhuset (vgregion.se)

Grants Office also serves as a contact point for collaboration with external partners for grant applications between healthcare actors, the life science industry, other authorities, and organizations.

Would you like regular updates on upcoming and current calls?

As a VGR employee, you are welcome to join our Viva Engage group. There we provide information and links to calls for proposals from various funding bodies.

Do you need support with an innovation project or applications to Vinnova?

Contact Grants Office – Innovation Platform

VGR Grants Office in Region Västra Götaland

Grants Office at Gothia Forum is part of the joint Grants Office in Region Västra Götaland, which also includes employees from the Innovation Platform. VGR Grants Office manages the region’s organizational account for Prisma and the EU.


Advice and project support for clinical studies

We provide advice and support on all types of clinical studies, such as ATMP, medical devices, pharmaceuticals and registry studies. We can provide assistance with individual steps or be involved in large parts of the research project. An early contact with us facilitates the planning and implementation of the clinical study.


Data management

We offer services in eCRF and data management for researchers within the Västra Götaland Region who wish to conduct a clinical study. We provide a one-hour free consultation where you can get an overview of our services and receive answers to basic questions. After an initial meeting, we can prepare a cost estimate for services that may be relevant to your project.


Monitoring/Quality Control

We offer monitoring services and can support you with services ranging from the design of a monitoring plan to the implementation of monitoring in the clinical trial.

Our monitors ensure that protocols, laws and regulations are followed and that data in the study is recorded correctly. Gothia Forum has extensive knowledge in different types of clinical studies and we monitor both clinical drug trials and medical device clinical trials.

Coordinated monitoring of investigator-initiated multicentre studies | Kliniska Studier Sverige


Health economy

We provide advice, support and conduct health economic evaluations. We offer a free one-hour consultation to answer basic questions or discuss research support needs.

We can carry out health economic evaluations, such as cost analyses, budget impact analyses and cost-effectiveness modeling studies.


Templates and other supporting documents

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CTIS – application for clinical trial with medicinal products

Clinical Trials Information System (CTIS) is used for clinical trials with medicinal products.

The system is used for:

  • Application for clinical trials within EU/EEA (authorization in Sweden by both Swedish Medicinal Products Agency and the Swedish Ethical Review Authority)
  • Notification of starting and ending a clinical trial
  • Annual Safety Reporting
  • Reporting results

When Västra Götalandsregionen is Sponsor

Gothia Forum is the High-Level CTIS administrator of Västra Götalandsregionen. Researchers who wish to apply for permission to conduct a clinical trial with medicinal products can contact gothia.forum@vgregion.se.

When Västra Götalandsregionen is trial site 

Use only the preregistered organisations found in OMS (Organisation Management Services, a central dictionary of organisations provided by the European Medicines Agency). The main entrances of the hospitals are registered, these should be used in CTIS applications. Write department and clinic address in the “department field”. 

Addresses, ORG-IDs and LOC-IDs of trial sites in all regions of Sweden are found here: 
Registrering av prövningsställe i CTIS | Kliniska Studier Sverige 

Questions regarding how trial sites within Västra Götalandsregionen should be registered in CTIS can be sent to 
gothia.forum@vgregion.se


Research process

On kliniskstudier.se describes the research process and what you should consider when conducting a clinical study. Depending on the type of study you want to do, the process and regulations look different. Some parts of the process are general, others are specific to a certain type of study.

Research process | Kliniska Studier Sverige