An open-label, multicenter, non-randomized interventional roll over trial for relapsing glioblastoma patients
PRODUCT TYPE
Medical device / Drug / Combination product
THERAPEUTIC AREA
Oncology – solid tumours
Relapsing glioblastoma patients
TRIAL
An open-label, multicenter, non-randomized interventional roll over trial
- 9 patients
- 2 sites in 1 country
ILIFE CONSULTING SERVICES
Clinical oversight, training and upskilling
MISSION LENGTH: 9 months
BACKGROUND
The Sponsor was a medtech company developing innovative medical devices to treat a wide range of severe brain disorders including brain tumors. As such devices require clinical evaluation, the Sponsor outsourced a complex clinical trial to a mid-size CRO.
CHALLENGES
During the course of the trial, the selected CRO was acquired by a larger one, and the Sponsor became dissatisfied with the quality of its deliverables and drifting timelines.
With limited internal resources and multiple clinical activities, the Sponsor needed additional resources to widen the reach of its clinical oversight and put the clinical trial back on track whilst recruiting new collaborators.
The Sponsor decided to outsource the clinical oversight to a trustworthy and experienced organization, able to put their clinical trial back on-track.
ILife Consulting offers the flexibility to transition the global project management back to a Sponsor at any given time and to train new recruits to high standards.
MISSION
ILife Consulting was brought in on short notice to fill the resource gap and perform clinical oversight on behalf of the Sponsor.
Amongst other items, ILife Consulting was tasked with selecting the central laboratory, setting up the monitoring documentation, site contract agreements, preparing the submission package for a protocol amendment in order to not suffer additional time delays on the strategic clinical trial and with providing support to the in-house clinical team whilst internal recruitment was taking place.
Once recruitment was successfully completed, the Sponsor missioned ILife Consulting with the training and upskilling of the new recruit and with a smooth transition of the outsourced clinical oversight back to the Sponsor once the newly recruited clinical project manager was fully autonomous in terms of clinical project management, and mastery of clinical trial tools, systems and procedures.
ILife Consulting assigned one of its senior clinical project managers to the Clinical Trial rescue as well as to the upskilling of a novel recruit
Throughout the mission, the Sponsor’s Head of Clinical Operations and ILife Consulting’s Project Manager worked hand in hand, had regular meetings and agreed on the level of standards required to train the newly recruited clinical project manager
During 9 months, ILife Consulting trained a junior Project Manager in clinical trial study set-up, clinical trial tools like CTMS, eTMF, eCRF, etc… giving the junior Clinical Project Manager the confidence to perform her duty
A well trained Clinical Project Manager provided reassurance to the Client’s Stakeholders in the ablity of the Sponsor’s team to perform clinical oversight according to Good Clinical Practices (GCPs) and internal high standards
Within 6 months, with the support of ILife Consulting, the Sponsor regained control over its clinical study and a smooth transition and exit if Ilife Consulting was achieved
RESULTS
Following this close collaboration, the Sponsor appreciated and valued the expertise, agility and methodology demonstrated by ILife Consulting whilst conducting clinical trials. The medtech company has pursued its collaboration with ILife Consulting for the management of its clinical trials.