TRAINING & UPSKILLING TO IMPROVE CLINICAL TRIAL OUTCOME

An open-label, multicenter, non-randomized interventional roll over trial for relapsing glioblastoma patients


Product and therapeutic area

PRODUCT TYPE

Medical device / Drug / Combination product


THERAPEUTIC AREA

Oncology – solid tumours

Relapsing glioblastoma patients


Clinical Trial

TRIAL

An open-label, multicenter, non-randomized interventional roll over trial

- 9 patients

- 2 sites in 1 country



Customized Offer


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.



Mission

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




Communication

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


Training

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



Goal

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



Success

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.