--- title: Managing Trial Documents from Start to Finish in an eTMF Application description: Explore the value that eTMF system solutions can provide trial sponsors and other stakeholders before, during, and after a clinical trial. image: https://blog.montrium.com/hubfs/Blog/Managing-Trial-Documents-in-an-eTMF.jpg --- [![Montrium_Logo_smaller](https://blog.montrium.com/hs-fs/hubfs/montrium-2023/images/logo/Montrium_Logo_smaller.png?width=130&height=32&name=Montrium_Logo_smaller.png "Montrium_Logo_smaller")](https://www.montrium.com/) ← - Products Close ## Book a live demo Schedule a demo with a representative. - ## Products Our pre-configured applications enable our clients to work better and smarter. ![63f778fbb0527c09d8b57985_Group](https://blog.montrium.com/hubfs/montrium-2023/images/header/63f778fbb0527c09d8b57985_Group.svg) ## Book on our demo today! 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Moreover, running larger clinical trials with greater than 1,000 patients can cost upward of $100 million.  When considering the statements made above, the phrase, “time is money” couldn’t be more relevant. With drug development being such a costly exercise, it probably comes as no surprise that **life sciences organizations are looking at every area to improve the way clinical trials and drug development is conducted.** Optimizing processes and improving the way activities are undertaken allow these organizations to shave hours, days, weeks or even months off of development timelines – which can amount to millions of dollars saved and millions of dollars of additional revenue. All of these drug development activities also generate a significant amount of documentation, which is maintained within a Trial Master File (TMF), as required by regulation and which in itself can represent a significant cost. Also, this documentation is still more often than not paper-based, which adds an additional cost burden. However, times are a-changing, and new [eTMF solutions](https://www.montrium.com/etmf-connect) are providing more cost-efficient methods for managing documentation while also providing other significant benefits. The following article explores the tremendous value that eTMF solutions can provide trial sponsors and other stakeholders. In fact, a well-designed [eTMF system](https://www.montrium.com/etmf-connect) can significantly accelerate trial setup, deliver comprehensive document visibility during the trial, and streamline access to trial records at the conclusion of the trial. ## Before the Trial: Accelerating Trial Startup Before a clinical trial can begin, the sponsor/pharmaceutical organization must have a series of different essential clinical trial documents in place as well as all of the relevant regulatory and ethics approvals. The efficient production of the initial essential documents required to get the trial up and running can be challenging. An electronic trial master file (eTMF) can significantly accelerate this startup process by: - Providing standard document organization structures based on the [TMF Reference Model](https://blog.montrium.com/blog/the-tmf-reference-model) that defines a logical document structure and create placeholders for required documents - Identifying missing documents and alerting the responsible parties - Simplifying document review and approval via automated workflows - Allowing external parties to communicate and collaborate directly in the system ## During the Trial: Improving Trial Document Visibility While an [eTMF platform](https://www.montrium.com/etmf-connect) can be leveraged to speed up trial and site startup, it can also bring significant value as an ongoing operational tool. During the course of a trial, the trial manager can leverage the [eTMF system](https://www.montrium.com/etmf-connect) to synchronize critical clinical trial documents across the entire stakeholder network, providing role-based access and visibility to sponsors, CRO staff, investigator sites and IRB members. Another important factor that an eTMF can impact is the ability to calculate and monitor inspection readiness and trial status against pre-defined milestones. Ensuring that the TMF is up to date is key to passing inspections.  eTMF software also makes it easier to re-route amendments and supporting information for approval when changes are made to operational documents. Without this type of automation and real-time delivery, changes can often stall a trial for weeks or months. In addition, [eTMF solutions](https://www.montrium.com/etmf-connect) with a standards-based integration layer can be connected to clinical trial management systems (CTMS), which contain site and investigator information, clinical trial metadata and milestones which can be used to evaluate eTMF status as the trial progresses and provide input on study events that impact eTMF content.  ## [![CTA_eTMF_10 FAQs_1200x460-3](https://no-cache.hubspot.com/cta/default/334618/interactive-182409977930.png)](https://blog.montrium.com/hs/cta/wi/redirect?encryptedPayload=AVxigLJIzHp%2FLqff0iAFcK1TAV4ROexkIbZjMj5ctq2gwigJgF%2FboJtypH6jyxsuiuhXiubkazGmExd4vkQ5W%2Bw2FqQ7skAuUO3emAeqda5j%2FkLEf4nyO9DrtH8pl4TYEKPBOjLmNfI5AECWkC8lff%2FRNdqJXTQNT6yrN0Gz9zD3jGxSoESU7GOLn6o%3D&webInteractiveContentId=182409977930&portalId=334618) ## After the Trial: Simplifying Access and Retrieval of Clinical Trial Documents Trial Master Files’ live on long after the clinical trial. Regulators often request specific clinical trial documents from the TMF be sent as soon as the trial is completed, as well as linking certain documents to future submissions when going through the marketing authorization process. At the end of the trial, the CRO will typically transfer the TMF to the sponsor for retention. Retention periods differ depending on the location you’re operating in and the regulatory agency requirements for that country. Some countries require TMF content to be retained for a minimum of 25 years, and there are changes afoot which may require many other countries to move towards this longer retention period. With the need to keep the TMF secure and retain for long periods, eTMF systems are the smart choice. eTMF systems make transferring the file and responding to requests much simpler. The electronic TMF eliminates the increasing cost of manual paper storage and handling, something that is far more expensive than virtual storage of electronic content. Moreover, agencies are starting to require direct access to the TMF for on-site and potentially remote inspections. Finally, an eTMF system gives clinical trial stakeholders the power of rapid document search and retrieval. This is bolstered further by the introduction of a standard eTMF structure and taxonomy, such as the [TMF Reference Model](https://blog.montrium.com/blog/the-tmf-reference-model). Access and retention policies can be set and enforced automatically. ## **Final Thoughts** There are immediate benefits that can be had by implementing an eTMF today and these benefits will continue to grow with the introduction of more comprehensive eTMF data models and completeness algorithms. eTMF platforms have the promise of unlocking the gold mine of data within our clinical trial documents, allowing for better decision-making throughout the drug development life-cycle.   ![Oliver Pearce](https://blog.montrium.com/hubfs/oliver1.png) Oliver Pearce Oliver heads up Montrium's Commercialization team and is a regular contributor to the Montrium blog. Oliver writes on a wide range of topics that tie in his passion for technology and his deep understanding of the regulatory requirements. ## Get our best content delivered straight to your inbox ![subscribe-top](https://20882350.fs1.hubspotusercontent-na1.net/hubfs/20882350/Montrium-2023/Blog/Images/subscribe-top.svg) ## You may also like [![](https://blog.montrium.com/hubfs/3%20-%20Landing%20Page%20Banners/Webinar---21st-Century-Clinical-Trials.jpg) - ClinOps 21st Century Clinical Trials: A Brand New 3 Part Webinar Series Read It](https://blog.montrium.com/blog/brand-new-webinar-series-21st-century-clinical-trials) [![](https://blog.montrium.com/hubfs/44442_1200x627_121721.png) - ClinOps - Trial Master Files Outsourcing clinical trials: How to balance oversight and expectations Read It](https://blog.montrium.com/blog/outsourcing-clinical-trials-balance-oversight-and-expectations) [![](https://blog.montrium.com/hubfs/Montrium_what%20is%20eTMF%20and%20do%20I%20need%20one.webp) - Trial Master Files - etmf audit trail - what is an etmf - etmf for biotech - etmf for phase 1 trial - electronic trial master file etmf What is an eTMF? Electronic trial master files explained Read It](https://blog.montrium.com/blog/what-is-etmf-software-and-does-my-organization-need-to-implement-one) [![](https://blog.montrium.com/hubfs/1329870_Blog-MHRASymposium_Op1_1200x627_032122.jpg) - ClinOps A reflection on the MHRA GCP Symposium: Trends that are transforming clinical trials Read It](https://blog.montrium.com/blog/mhra-uk-gcp-symposium-trends-clinical-trials-trends) [![](https://blog.montrium.com/hubfs/Benefits%20eTMF.jpg) - Quality - Inspection Readiness - Trial Master Files 10 Benefits TMF Managers are Achieving with eTMF Systems Read It](https://blog.montrium.com/blog/10-benefits-tmf-managers-are-achieving-with-etmf-systems) [![](https://blog.montrium.com/hubfs/11%20-%20Images/Stock%20images/ActiveTMFManagement.jpg) - ClinOps - Trial Master Files 5 Ways the New eTMF Navigator Will Change How You Manage Clinical Trials Read It](https://blog.montrium.com/blog/4-ways-the-new-etmf-navigator-will-change-how-you-manage-clinical-trials) [![](https://blog.montrium.com/hubfs/Why%20most%20clinical%20trial%20risk%20assessments%20fail%20to%20drive%20action%20under%20ICH%20E6(R3)%20(and%20how%20to%20fix%20them)%20-%20Cover.png) - ClinOps - Quality Why most clinical trial risk assessments fail under ICH E6(R3) (and how to fix them) Read It](https://blog.montrium.com/blog/why-clinical-trial-risk-assessments-fail-under-ich-e6r3-how-fix-them) [![](https://blog.montrium.com/hubfs/Blog/Business-Case-eTMF-Thumb.jpg) - ClinOps - Trial Master Files How to Create a Business Case for eTMF That Your Board Can't Refuse Read It](https://blog.montrium.com/blog/how-to-create-a-business-case-for-etmf-that-your-board-cant-refuse) [![](https://blog.montrium.com/hubfs/MicrosoftTeams-image%20(42).png) - ClinOps Decentralized clinical trials: A growth lever for scaling life sciences organizations Read It](https://blog.montrium.com/blog/decentralized-clinical-trials-scaling-life-sciences-organizations) [![](https://blog.montrium.com/hubfs/Montrium_10%20FAQ%20about%20TMF-1.webp) - Trial Master Files 10 FAQ’s About Trial Master Files (TMF) and Archiving….Answered Read It](https://blog.montrium.com/blog/10-faqs-about-trial-master-files-tmf-and-archiving-answered) ## Get our best content delivered straight to your inbox [![Montrium_White_Logo_smaller](https://blog.montrium.com/hs-fs/hubfs/montrium-2023/images/logo/Montrium_White_Logo_smaller.png?width=130&height=32&name=Montrium_White_Logo_smaller.png "Montrium_White_Logo_smaller")](https://www.montrium.com/) #### Montrium eTMF - [eTMF Connect](https://www.montrium.com/etmf-connect) - [eTMF Connect features](https://www.montrium.com/etmf-connect-features) #### Montrium RIM - [RegDocs Connect](https://www.montrium.com/regdocs-connect) - [RegDocs Connect features](https://www.montrium.com/regdocs-connect-features) #### Montrium QMS - [Quality Connect](https://www.montrium.com/quality-connect) - [Quality Connect features](https://www.montrium.com/quality-management-software-features) #### Platform overview - [Platform overview](https://www.montrium.com/platform-overview) - [Pricing](https://www.montrium.com/pricing) - [Montrium FAQ](https://www.montrium.com/faq#anchorFaq) - [Trust center](https://www.montrium.com/trust-center) #### Resources - [Demo center](https://www.montrium.com/demo-center) - [Resource center](https://www.montrium.com/resource-center) - [Podcasts](https://www.montrium.com/podcasts) - [Webinars](https://www.montrium.com/webinars) - [Blog](https://blog.montrum.com/blog) #### Montrium by industry - [Non-profit](https://www.montrium.com/montrium-by-industry/non-profit) - [Medical device](https://www.montrium.com/montrium-by-industry/medical-devices) - [CRO](https://www.montrium.com/montrium-by-industry/cros) - [Pharma/Biotech](https://www.montrium.com/montrium-by-industry/pharma-biotech) #### Adobe Acrobat Validation - [Adobe Acrobat validation services](https://www.montrium.com/adobe-sign-validation-services) - [Free Adobe Acrobat validation pack](https://www.montrium.com/adobe-sign-validation-pack) #### Montrium by team - [Clinical operations](https://www.montrium.com/clinical-operations) - [Regulatory affairs](https://www.montrium.com/regulatory-affairs) - [Quality and compliance](https://www.montrium.com/quality-and-compliance) - [IT & security](https://www.montrium.com/it-and-security) #### Company - [About](https://www.montrium.com/about) - [Newsroom](https://www.montrium.com/newsroom) - [Events](https://www.montrium.com/events) #### Contacts 507 Place d'Armes,Suite 1500 Montreal, QC H2Y 2W8,Canada +1.514.223.9153  [info@montrium.com](mailto:info@montrium.com) Montrium Europe SPRL,Boulevard de Waterloo77 1000 Bruxelles, Belgium +32.2.808.3008 [info@montrium.com](mailto:info@montrium.com) #### Socials [Follow us on Facebook](https://twitter.com/Montrium) [Follow us on Instagram](https://www.facebook.com/Montrium/) [Follow us on Instagram](https://www.linkedin.com/company/montrium) Montrium Inc. 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