Our Case Studies
Streamlining a Multi-Center Clinical Trial from Concept to Launch
A case study of AdvanSci's clinical trial management service for the GLUSorb trial
Background
A research team led by Dr. Sandra Lindstedt aimed to test CytoSorb®, a medical device that filters inflammatory cytokines from the blood, to improve outcomes for lung transplantation patients. The goal was to determine if reducing inflammation could enhance lung function and reduce rejection risks post-surgery.
The Challenge
Launching the GLUSorb trial was a complex mission with four major hurdles. First, the team had to navigate the new and complex Medical Device Regulation (MDR), a critical requirement for approval. At the same time, they faced immense Resource Management challenges, needing to coordinate detailed trial documentation, multi-center logistics, and regulatory submissions across multiple sites.
Furthermore, Securing Funding was essential; the multi-center trial required significant financial support to be conducted. Underpinning all of this was the need for Specialized Documentation: the creation of high-quality documents for ethics, regulatory, and funding applications, each requiring precision and expertise.
Regulatory Navigation
Specialized Writing Demands
Funding Acquisition
Time and Resources
Constraint
Our Solution
Following Funding, we focused on protocol finalization and regulatory strategy. Collaborating closely with the principal investigators, we refined the study design and authored the complete Clinical Investigation Plan (CIP). Our team prepared all subsequent trial documentation and managed the regulatory submission process to meet Medical Device Regulation (MDR) requirements.
A dedicated trial manager coordinated all parties, including clinical sites, vendors, and researchers, to guarantee efficient trial initiation. This coordination ensured the timely preparation of essential trial components, including the electronic Case Report Form (eCRF), Trial Master File (TMF), Investigator Site File (ISF), and monitoring plan.
Finally, to establish early scientific validation, we provided expert advising and editing to prepare the trial protocol for publication in a peer-reviewed journal. This support made the methodology available to the international research community.
Project Management
Regulatory Support
Publication Support
The result
Funding secured
19.5 MSEK
Awarded funding from VR.
The trial protocol is published (https://pmc.ncbi.nlm.nih.gov/articles/PMC10753425/
We kept the trial regulatory approval and study start-up on schedule, and the study started within 9 months of receiving funding.The trial is ongoing and will provide important information about a new potential therapy to improve outcomes in lung transplantation.
