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Case Study

EASi Provides Contract and Budget Support for Clinical Trials

EASi provides a biotechnology and pharmaceutical company with more transparent and cost-controlled support to ensure compliant practices are followed in clinical agreements and investigator budgets.

The client
Our client is a multinational biotechnology and pharmaceutical company with locations across the U.S. and Europe. Its portfolio of products addresses many major disease areas, including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation. Our customer was leveraging a clinical research organization (CRO) to support contracts and budgeting for clinical trial sites. With the many studies our customer had running concurrently, oversight and control of each clinical agreement and site-level budget negotiation was critical.

The incumbent CRO was acquired by another organization, which resulted in increased costs to our customer. These financial and operational changes were not effectively communicated to our customer. Due to the importance of this work to our customer’s operation and its need for visibility and control, our customer decided to bring this work back in-house via an in-sourced solution.

The EASi solution
To take the contracting and budgeting work back in-house and improve cost-efficiency and visibility, EASi built and managed a team that worked on-site with our customer. As a part of onboarding, EASi’s team recorded, completed and tracked essential learning modules in line with the customer’s standard operating procedures (SOP) within two weeks of each team member’s start date.

With robust talent acquisition capabilities and a strong onboarding plan, EASi was able to ramp up the team quickly and establish its support efficiently.

Line management by EASi’s program management team included regular performance reviews for our service team, workload forecasting to project capacity needs and contingency planning for resource attrition. Our program management team ensured that site budgets were on track for timely completion.

Additionally, our program manager served as an escalation point to communicate contractual needs from our team to our customer’s internal management. EASi also developed a communication plan based on our own expertise and our customer’s internal standards to provide transparency and visibility. Resource planning, progress toward program metrics and financial status reporting were shared during regular governance meetings. Governance meetings were also an opportunity for EASi to share information and metrics on progress towards study sites’ activation.

The results
EASi’s service model provided the customer with a more transparent and cost-controlled method to ensure ethical, fair and compliant practices were followed when developing, negotiating and executing clinical agreements and investigator budgets. By working cross-functionally with our customer’s contracts, feasibility and study support services for its U.S. trial sites, EASi helped local study teams ensure that budgets met the needs of our client’s legal team and each individual study site.

EASi’s support helped drive timely delivery of regulatory documents at sites, which prevented potential delays in start-up activities and risks to the activation plan. We also updated multiple internal systems to ensure that all parties had the most relevant and up-to-date information.