Case Study

EASi Provides Crucial Clinical Operations Support for a Phase IV Study

A biopharmaceutical company upgrades its clinical operations support for a new study, choosing a best-in-class FSP solution from EASi that prioritizes quality, productivity and communication.

The client and challenge
The client is a biopharmaceutical company that discovers, develops and markets biopharmaceuticals as well as small molecule drugs. Typically, it runs studies in-house and outsources overflow work to contract research organizations (CROs). However, its internal project managers were not receiving the promised level of service from the CROs, forcing them to spend a significant amount of time and effort in the outsourced studies and having a negative impact on their bandwidth for other studies that were being run in-house.

At the time, the client had master service agreements set up for staff augmentation and clinical research outsourcing. Because neither of those models had proven effective for its business needs, the company needed to support this work with a different service model.

The EASi solution
EASi developed and implemented a customized, in-sourced functional service program (FSP) for this client. This was accomplished using our pharmaceutical industry experience, a longstanding relationship through our parent company and dedicated delivery oversight and management. Our solution combined industry-leading recruiting power with the necessary program oversight and operational management to extend the customer’s bandwidth and drive visibility, productivity and quality for our customer’s study.

We engaged with the client’s medical affairs team to build and deploy a dedicated, managed solution for an observational study for subjects with a gastroenterological disorder. EASi identified the functional gaps that required support for this study and developed its program to execute and manage three critical areas of clinical operations: study management, data management and monitoring. The remaining functions were managed by the customer.

To effectively offload management functions from the customer’s project manager, our technical team was overseen by a line manager. EASi’s line manager oversees the study manager, providing best practices and guidance on managing the protocol and making recommendations to the customer. Line management responsibilities also include:

  • Meeting with EASi project team (weekly calls and monthly visits)
  • Performance evaluations and management for all project resources, conducted at least semiannually and at most quarterly
  • Attending study team meetings
  • Participating in communication planning
  • Supporting issue and conflict resolution
  • Strategic planning and contingency planning
  • Resource allocation
  • Budget oversight and management
  • Forecasting
  • Amendments to schedules and change orders, working with the customer on timeline extensions and protocol revisions
  • Managing all time and expenses for EASi study resources
  • Metrics management and reporting

Through the line manager, EASi is able to proactively communicate issues that impact milestone goals. Our study manager ensures milestone goals are hit on time and to customer standard, working with our team to make sure enrollment goals are met. We keep the customer updated on key metrics and timelines, providing transparency on all activities within the study to all levels of the customer’s organization, from the project manager up to the director. This is accomplished through regular governance and operations meetings.

Operations meetings are conducted twice a month with the customer’s project manager to discuss study-specific tasks and milestone goals. Governance meetings are held semiannually with the customer’s leadership team and are used to discuss progress updates, issues and solutions within the study. These meetings prioritize communication, collaboration and visibility to ensure timelines are maintained and achieved with high-quality outputs.

The results
The study managed by EASi Sciences’ FSP is in the second year of a three-year program and we are working to ensure an on-time database lock, pending an increase in enrollment efforts. We are currently overseeing 19 active sites and have 27 patients enrolled, maintaining targets set by the customer. To date, 18 patients have completed the study, and we have helped the customer successfully implement an amendment across all active sites to improve enrollment. The customer has been able to effectively offload the study from its internal project manager while maintaining visibility and adhering to schedule, extending the customer’s bandwidth for in-house studies and projects.

Despite a small target population and other competing studies, the client has reported that EASi is managing a difficult study well. It is the last post-market study required for this drug, and the customer is looking at how it can replicate EASi’s FSP model for other drugs in Phase IV studies.

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