The last major frontier in automating clinical operations: Study Startup
Spanning Site Identification, Selection, and Activation
There is intense pressure to speed clinical trials and restrain costs, but inefficiencies tied to complicated protocols, globalization, and paper-based methods have stalled these efforts. Cloud-based solutions such as clinical trial management systems (CTMS), electronic data capture (EDC), and the electronic trial master file (eTMF) are all quantum leaps, but their adoption rates vary. And significantly, they do not address the only part of a studies lifecycle, which can impact the overall timeline of clinical trial conduct—study startup (SSU). SSU encompasses activities such as country selection, pre-study visits, site selection and initiation, regulatory document submission, contract and budget execution, and enrolling the first patient.
There has been a strong focus on study conduct, but as stakeholders are increasingly aware that better SSU processes are linked to shorter clinical timelines, the emphasis is shifting in that direction.
In this webinar we will explore:
- How does an SSU solution differ from an existing CTMS or eTMF solutions?
- Benefits to using dedicated SSU solutions
- Challenges to integrating eClinical applications
This webinar is applicable to:
- Sponsor and CRO roles responsible for site selection and activation
- Sponsor and CRO roles responsible for collecting and evaluating startup metrics
- Investigator site personnel responsible for collaborating with Sponsors and CROs
Doug has over 10 years of experience in the building and implementation of software integrations for Enterprise SaaS applications for fortune 100 companies. His primary focus has been on REST and SAML2.0 to integrate 3rd party software, customer ESB and internal applications. Doug leads the integration of the goBalto study startup suite of applications with leading eClinical systems and holds PMP and ACP certifications from the Project Management Institute (PMI).
Director, Project Management & Integrations
Eldin has over 17 years industry experience prior to becoming a consultant. In 2003, Eldin left Pfizer as Associate Director of Records Management and established Rammell Consulting to help companies and organisations improve their records management processes.
Eldin has been a speaker at conferences including Records Management Society, MHRA Symposia, InfoTech Pharma, the Drug Information Association (DIA), European Forum for Good Clinical Practice (EFGCP), CBI/Advanstar, ExL-Pharma and Applied Clinical Trials; he has been a guest lecturer at City University, London; he has published articles in the GCP Journal and Clinical Researcher. He is an Executive Committee Member and past-President of the Good Clinical Practice Records Managers Association (GCP-RMA) and Director in the Scientific Archivists Group. Learn more
Managing Director and Principal Consultant
Rammell Consulting Limited
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Contact us with your questions or to schedule a demo.