Electronic trial master file (eTMF) management has traditionally been conducted separately from the clinical trial management system (CTMS), which often needs to track documents within the eTMF. Integration of eTMF and CTMS eliminates redundancies, improves workflows, enhances transparency and enables greater study control.
In this webinar, industry experts from Bioclinica and RegDocs365 will discuss the following:
- The importance of robust document and study management systems
- When to consider moving beyond eTMF management to incorporating a CTMS for study management
- The ways in which integrating your eTMF and CTMS improve document and study management within and across all studies
- How the use of a familiar, customizable and flexible interface such as SharePoint improves user adoption, improves efficiencies and reduces the cost of implementation
- Utilizing content within your documents to enhance your CTMS and eTMF integration
Speakers
Jeremiah Rehm, Senior Product Manager, Bioclinica
Jeremiah Rehm has been modernizing clinical systems within the life sciences industry for over twenty years and was directly involved in the design and improvement of several production products. Prior to joining Bioclinica, he worked as a technology consultant and led the product management division at TranSenda International. He specializes in the use of visualization platforms to consolidate and analyze operational study information, including the translation of these data points into meaningful performance metrics.
Message Presenter
Keith Parent, Co-Founder and Partner at RegDocs365, Founder and CEO, Court Square Group
Keith Parent founded Court Square Group in January 1995 and has been the company’s CEO since inception. Under Parent’s leadership, Court Square Group has built a reputation as an industry leader in the life sciences industry. With over 35 years of technology and leadership experience in the life sciences industry, Parent has a clear understanding of regulatory challenges and the Good System Practices (GSPs) required to maintain a Qualified state for the company’s clients.
Parent holds a Master of Science in Computer Science (MSCS) from Rensselaer Polytechnic Institute and a Bachelor of Science in Computer Science from Siena College. Parent has been involved in the implementation and maintenance of enterprise-level systems across the pre-clinical and clinical organizations of numerous Life Science clients. Under Parent’s direction, Court Square has managed over 5,000 servers world-wide for their Life Science clients, including CTMS systems, Global Submission systems, eCTD systems, FDA Gateways, Adverse Event Reporting systems, as well as numerous Clinical Trial systems and Longitudinal Patient Registry development systems with responsibility for over 100,000+ users in various clinical settings.
As a Co-Founder and Partner at RegDocs365, Parent has endeavored to bring enterprise level content and data management solutions to a much wider audience within the Life Science community while maintaining a cost model suited to growing companies. Parent has been a consultant to Pfizer Pharmaceutical for over 27 years and has held other leadership positions in the Life Science Industry. He is a regular guest speaker at many Life Science events and a thought leader for companies that are building solutions in the Life Science Industry. Parent continues to play a role in numerous DIA Working groups and is currently on the DIA RIM Working group model team working on the next RIM Reference model.
Message PresenterWho Should Attend?
This webinar is suitable for managers, leads and other relevant job titles in the following departments:
- Medical Directors
- VP, Clinical Operations
- Director, Clinical Operations
- Associate Director, Clinical Operations
- Manager, Clinical Operations
- Clinical Research Associates
- Clinical Study Managers
Xtalks Partners
Bioclinica
Bioclinica is a global, life-science provider that utilizes science and technology to reduce risk of clinical trials – helping companies to develop new, life-improving therapies more efficiently and safely. The company’s offerings include medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments and budget forecasting; pharmacovigilance, and trial management.
Court Square Group
Court Square Group’s Audit Ready Compliant Cloud™ (ARCC) platform for Life Science companies and out-of-the-box tools including RegDocs365 deliver FDA 21 CFR Part 11 compliant, validated and cost-effective solutions to manage all digital content (EDMS/documents, voice, data, and video) and regulatory submissions (eSignature, eCTD, EDM & eTMF Reference Models, GxP audit ready, and submission-ready PDF rendering). With over 25 years’ experience, and 95% client retention, Court Square Groups has supported over 1,000+ submissions.
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