The client and challenge
Our client is a global, oncology-focused biopharmaceutical company who is devoted to providing transformative therapies to people bravely facing cancer. To monitor and manage Phase II and III studies, our client worked with a contract resource organization (CRO) that provided monitoring resources, a clinical trial management system (CTMS) and utilizing the client’s SOPs. The CRO was struggling to retain quality personnel, and was falling drastically behind on timelines due to turnover, quality, delays in site initiation, enrollment and relationships with the sites. In addition, our client needed improved communication and HR/line management oversight necessary to screen, hire and retain senior-level leads.
With critical milestones approaching, an increasing backlog and several new studies expected to launch throughout the upcoming year, the client began to move its clinical trial activity in-house and requested lead oversight roles in the U.S. and EU. This change required it to build an internal support structure to manage and retain the current study resources, be prepared to quickly hire new resources when additional studies launch and accommodate the build-out and implementation of a new CTMS system.
The EASi solution
EASi provided experienced, quality clinical leads in a timely manner as well as line management capabilities with a focus on ensuring retention and achieving project specific deliverables. EASi designed a flexible and scalable service model designed to support our client’s key clinical programs as well as accommodate their evolving business needs by outlining specific project deliverables in SOWs. Our service model included a dedicated program manager (PM) to provide the necessary line management oversight while keeping the overall technical control with our client. We developed semi-annual employee performance reviews to improve retention and allow resources to focus on quality outputs to ensure deliverables were being met on time. In addition, we developed a team of qualified resources ahead of timeline expectations by leveraging Aerotek’s recruiting and staffing division.
Principal duties and responsibilities for our clinical lead team included:
- Building partnership with site personnel and acting as escalation point to ensure compliance with protocol and SOPs.
- Conducting oversight monitoring and management of internal clinical research associate (CRA) team and CRO monitors. Overseeing three-five monitors for assigned study across 35-45 sites.
- Manage risk-based monitoring activity, conduct site assessment and develop mitigation plans.
- Participate in all SIV and co-monitor as needed. Review all CRA trip reports and ensure compliance with protocol requirements, data metrics and timely reporting of adverse events and/or violations.
- Monitor budget and partner with sites to boost recruitment
- Invoicing based on time and materials with set performance and retention bonus achievement milestones
- A mutually developed, customized governance model and communication plan that outlined a monthly call schedule as well as a semi-annual formal performance management evaluation to review the work outputs from our resources and provide consistent updates regarding the health of our partnership.
Our managed program directly improved site monitoring and management by helping the client get back on track through a cost-effective model that significantly improved data metrics, achieved milestones, improved employee quality and retention and improved relationships with site and CRO personnel. In addition, our customer was able to submit the drug for approval to the U.S. Food and Drug Administration (FDA) ahead of schedule. By implementing a resource management team as well as hiring and retaining the clinical leads, our customer met project timelines and milestones and was able to market their drug three months ahead of schedule. This project team grew from four resources to 25 in a few years to support 14 studies globally.
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