A Case Study: Expanded Access Programs
Med Communications has many happy clients, and in our series of case studies, we talk about some of our long-term clients, the challenges we face alongside them, and how we help them be more efficient, increase the quality of their calls and documents, and use the efficiency and the scalability we offer to meet their budgetary needs.
This case study focuses on a biopharmaceutical client who needed a partner to support an Expanded Access Program.
Read our case study below for more information.
Case Study: Partnership Provides Scalability and Clinical Operations Expertise
Answering questions from patients, family members, and health care providers involved in Expanded Access Programs across the globe
Implementation of an EAP
Provide a scalable team that can handle all aspects of the EAP
Move forward with Expanded Access Program within tight time constraints without burdening in-house staff
Client: Biopharmaceutical client
Client needed support for an Expanded Access Program (EAP) and needed a partner who had the expertise in supporting such a program and who could quickly meet an unknown query volume.
Med Communications put together a highly trained team headed by a Team Lead who was the main “go to” person for the client. The support provided by this team was flexible and efficient, closely monitoring and mirroring the needs of the client organization. Our team of health care professionals and customer service representatives responded to questions from patients, family members, and healthcare professionals involved in EAPs across the globe. Our Medical Information team pre-screened enrollees, connected them with study sites, and answered medical or administrative questions they had, including follow-up on adverse events and product quality complaints during the EAP. These services were provided on a 24-hours-a-day, 7-days-a-week basis. We communicated with relevant patient organizations, advocacy groups, and registries, providing each with a short synopsis of the clinical trials and relevant contact information, helping the client connect with international organizations and patient support groups as needed, preparing FAQ documents that address common questions asked by callers. We also worked with study sites as needed, facilitating CASE STUDYscreening by reminding patients to collect all relevant documentation, creating and providing study brochures, and liaising between the study sites and the client. Our experienced team also responded to all medical information questions, and processed adverse event and product complaints from the study drug. Med Communications has the capacity and flexibility to accommodate fluctuations in activity such as a large unexpected surge in query volume. We were able to seamlessly service a volume increase that increased a hundred fold overnight.
Our partnership with this client allowed them to implement a EAP within tight time constraints without burdening their existing staff or hiring additional staff.