Genocea Biosciences Implements Wingspan eTMF
Genocea Biosciences has partnered with Wingspan Technology to implement a validated, inspection- ready, 21-CFR-Part 11 compliant electronic system. The implementation provides one central location for internal employees, contracted partners, and potential regulatory inspectors to quickly access Genocea’s clinical documentation in a controlled environment. Live in less than 9 weeks, the full-featured implementation of Wingspan’s eTMF included minor configuration changes to the out-of-the-box eTMF to support Genocea’s processes and their adoption of the Reference Model 3.0. Genocea’s implementation was supported by Wingspan’s Timeline Accelerators for UAT, Training, and SOPs. “By offering a customizable eTMF system and training package, we are able to work with customers of every size to meet their specific needs, timeline, and budget,” said Troy Deck, CEO of Wingspan Technology. “Our out-of-the-box eTMF incorporates TMF Reference Model 3.0 and can be implemented in four to 10 weeks based on client-directed configuration changes. We are always happy to work with our customers to help improve and streamline their organization’s TMF process, as well as to customize the eTMF to meet their exact requirements.” Genocea is currently migrating files from their early phase clinical projects as well as using the system for ongoing and future trials. Easy-to-use, standardized processes, supported by the Wingspan eTMF give cross-program consistency to clinical documentation, and enable Genocea to quickly assess TMF health and inspection-readiness as they continue to expand clinical operations. About Wingspan Technology, Inc. Wingspan Technology, Inc. is the leading provider of life sciences and eClinical software solutions, including Wingspan eTMF and DocWay, the SharePoint/Documentum integration product suite. Wingspan's talented and knowledgeable engineering and project management teams offer in-depth industry knowledge and experience to companies in life sciences, pharmaceutical, financial services, and other fields.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
