A large-pharma sponsor was looking for a medical imaging partner to support a four-year phase 3 Multiple Myeloma study. This trial included 600 patients across 200 sites and required expedited start-up and turnaround times.

The sponsor had experienced delays with a different clinical research organisation (CRO) on a sister study. The delays and performance issues prompted the sponsor to seek out the support of a new imaging CRO who could demonstrate speed, efficiency and the right scientific expertise required to support this trial.

The sponsor was looking for an imaging partner who could demonstrate the ability to deliver expedited study start-up and turnaround times for central radiology and clinical data review, along with the scientific expertise to provide the central data reads. More specifically, they requested to have the Independent Review Charter (IRC) finalised 40 business days after the kick off meeting and the radiology and clinical read system ready 63 business days after the contract was executed.

ICON Medical Imaging demonstrated a very clear, well thought out approach that proved we had the scientific, operational and organisational skills to deliver this trial according to their strict requirements.

From the beginning speed was paramount. The lead time from contract completion to study start-up was an impressive three days. A very important first step was the Charter Development meeting. Full teams with stakeholders from both ICON and the sponsor attended workshops to develop critical documents including site manual and independent review charter.

Clearly defined responsibilities, communication channels, timelines, and governance structures were also agreed, with commitment from all parties to full adherence. This proactive approach ensured a common understanding across both teams and was a critical contributor to the eventual success of the project.

Another critical element of this project was the scientific input required for critical data reviews. During the RFP process ICON was able to provide evidence of a strong panel of external central readers who specialised in oncology. Firecrest, ICON ́s investigator portal, was utilised to support timely site training, giving site staff full centralised access to all study documentation. ICON’s project team successfully expedited timelines for all deliverables through proactive risk management and planning, as well as leveraging template documents and processes.

The team was hands-on with their reader management to ensure critical timeline awareness, read forecasting, and workload management. This foresight and planning was also useful when conducting full data quality checks and timely data transfer according to the data manager’s specifications.

The overall objective of the sponsor was to obtain data faster so that they could make decisions and move forward with their multiple myeloma drug development.

In accordance with the sponsor’s requirements the Independent Review Charter was completed within 40 business days. The first central data reads have been delivered and the sponsor is extremely happy. As this partnership grows we will engage in continual evaluation to further refine the process and mitigate against any future risks.