About us Solutions Capabilities Therapeutic Areas Resources Careers Submit an RFP EN eTMF Implementation Excelya>Capabilities>eTMF Implementation SOFTWARE + MANPOWER Getting your study submission-ready 32% of FDA submissions have critical data conformance issues. Clearing up these issues delays market approval for vital drugs. You need to understand your studies holistically so that you know you’re inspection- and audit-ready. We use Veeva Vault, the market’s leading eTMF software, and augment those capacities with our best-in-class processes, procedures and implementation experience. You know that your studies are backed by the best. SEE OUR BROCHURE Choose from our full-service offer or stand-alone services To be submission-ready, your Trial Master File needs to be complete, consistent and accurate. We create a TMF plan, upload your documents review them for quality and ensure they are inspection ready. Then we archive them using Veeva’s eTMF software to make sure your documents are readily available when you need them. We can take care of every step or just one. Choose the offer that works best for you: Full-service suite including eTMF Stand-alone eTMF services pTMF to eTMF conversion Dedicated team working with sponsor’s Vault Inspection readiness checks, extra checks and quality reviews of existing eTMF Our advantages Regardless of the service you choose, we ensure success by providing the following advantages: Dedicated central reviewer team Trained project leaders, CRAs and CTAs in multiple countries Processes and technology such as Veeva Snap to drive efficiency and eliminate errors Metrics and markers to detect errors and gaps in eTMF on an ongoing basis Final review with eTMF specialists to double check for quality Metrics LET US HELP YOU LEVERAGE ETMF Contact us Gain immediate visibility into trial status, trial process and TMF quality by leveraging our eTMF offer. We’re looking forward to discussing your needs. CONTACT EXCELYA The highest quality CRO with the most comprehensive service coverage throughout Europe Contact Excelya 738 rue Yves Kermen 92100 Boulogne Billancourt +33 (0)1 46 20 74 50 Contact us Discover About us Solutions Capabilities Therapeutic Areas Careers Data Protection Notice Cookie Notice Legal Notice Newsletter By subscribing, you acknowledge that you have read our Data Protection Notice and that you wish to receive marketing communications from Excelya. We are social Excelya 2021. All rights reserved. EN Contact us Join us At Excelya, we use cookies to allow our users to navigate through our website, remember their preferences and for audience measurement. By clicking on “Agree”, we will also use cookies to track and analyze user behavior, allow interaction with social networks, and for targeted advertising. For more information, including on storage and third parties, please check ourCookie Notice Reject All Accept All Cookies Cookies Settings