EASi helps a client continue to provide innovative products while scaling up its clinical trial operations by establishing and managing a team to activate study sites.
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 maintains a mix of in-house and contracted resources to adjust its capacity with the shifting needs of its trials. To diversify its lines of business and continue providing innovative products, our customer increased its number of trials in various therapeutic areas. The customer was unable to scale up internal capacity to meet the current and future site activation workload due to the sizeable increase of new trials and sites. Because of budgetary restraints and the need for additional work scheduling, the customer’s existing operating models were not sufficient to support the increased workload.
To address the additional workload, our customer required a managed solution to activate trial sites in accordance with standard operating procedures (SOP) and industry/regulatory best practices.
The EASi solution
EASi established and managed a team to activate study sites on our customer’s behalf. We established a service structure for coordinating administrative activities from start-up through site activation across.
Our site activation team participated in the customer’s U.S. Site Management and Monitoring (SM&M) team; we set up study locations with up-to-date regulations and protocols so that the sites were adequately prepared. EASi actively participated in local study delivery team meetings and provided binders of applicable regulations to site monitors, support services and research sites. EASi regularly provided these groups with updated information on regulations and study protocol. EASi also proactively identified possible risks and delays in the site activation plans. All risks were addressed and monitored during our regular governance meetings with the client. EASi’s team worked within the customer’s various document management systems to update records and ensure information accuracy and compliance with our customer’s SOPs.
To provide oversight and service support for the customer, EASi’s program management team was responsible for:
Our proven process management capabilities and unparalleled access to talent through our parent company, the leading provider of scientific/clinical staff augmentation in the U.S, made us the ideal partner for a managed solution. EASi’s site activation team ensured that all requirements for site activation, for an average of 50 centers per month, were completed. To accurately prepare sites for delivering on a study, EASi leveraged our customer’s procedural documents and SOPs alongside European, American and local regulations. EASi took great care to ensure that each site’s individual study needs were addressed. All regulatory binders and study supplies were delivered in accordance with the individual trial requirements and local site activation protocol.