TRAINING & UPSKILLING TO IMPROVE CLINICAL TRIAL OUTCOME
- Voisin Céline
- Jun 23, 2022
- 3 min read
Updated: Mar 5
An open-label, multicenter, non-randomized interventional roll over trial for patients relapsing from glioblastoma and candidate to chemotherapy
PRODUCT TYPE
Medical device / Drug / Combination product
THERAPEUTIC AREA
Oncology – solid tumours
TRIAL
- 9 patients
- 2 sites in 1 country
ILIFE CONSULTING SERVICES
Clinical oversight, training and upskilling
BACKGROUND
The Sponsor was a medtech company focused on 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.
During the project, the selected CRO was acquired by a larger one, and the Sponsor became dissatisfied with the quality of the CRO’s deliverables. The selected CRO was not performing well, and timelines were not being kept.
In addition, with limited internal resources and multiple clinical activities, the Sponsor needed additional resources to perform clinical oversight and put the clinical trial back on track whilst recruiting new collaborators.
CHALLENGES
The Sponsor faced a dual challenge: ensuring effective clinical oversight of a trial in distress while simultaneously training a newly recruited junior project manager. The situation demanded immediate action and expertise to address operational gaps and maintain study momentum. The complexity of the trial, coupled with the inexperience of the new recruit, highlighted the need for a partner capable of rapidly mastering the study's intricacies and providing hands-on support.
The Sponsor had no other choice than to outsource the clinical oversight to a trustworthy and experienced organization, able to put their clinical trial back on-track.
MISSION
ILife Consulting was brought in on short notice to fill the resource gap and perform the clinical oversight on behalf of the Sponsor.
Amongst other things, ILife Consulting was tasked to select the central laboratory, to set-up all the monitoring documentation, to manage the site contract agreements, to prepare the submission package for a protocol amendment in order to not suffer additional time delays on the strategic clinical trial and to provide support to the in-house clinical team whilst internal recruitment was taking place.
Once recruitment was successfully completed, the Sponsor missioned ILife Consulting to train and upskill the new recruit and to perform 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 oversee the trial rescue and mentor the junior recruit
Collaborating closely with the Sponsor’s Head of Clinical Operations, ILife established clear training objectives and operational standards through regular meetings and a shared focus on excellence
Over a 9-month mission, ILife’s expert ensured the new project manager was upskilled (clinical trial study set-up, clinical trial tools like CTMS, eTMF, eCRF, etc…) while simultaneously bringing the study back on track
Within 6 months, the Sponsor regained full control of the trial, supported by a well-trained project manager, and ILife successfully managed a seamless exit transition.
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.
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.