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How to make sure that an eTMF is compliant to new TMF EMA Guideline?

18th December 2018 EMA published a long-awaited “Guideline on the content, management and archiving on the clinical trial master file (paper and/or electronics)”. The release acquired many questions regarding the new reality of TMF, that everyone working in the EU will have to deal with after the document’s effective date 18/06/2019. How to make sure that an eTMF is compliant to new TMF EMA Guideline? Use our checklist (exact quotes from […]

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Top eTMF Audit Expectations and Preparation Strategies that Matter

With so many CROs switching to an entirely digital format for their Trial Master Files, the legislators in charge of the regulations which govern compliance with international GCP standards are being forced to adapt as well. The nature of these changes has been conducive to simplifying and fortifying the entire auditing process, not only making clinical trials safer on the whole but making sure potentially valuable information is kept accessible […]

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Keeping Critical Data Safe and Accessible Using eTMF Technology

In an age where nearly a hundred percent of your clinical research organization’s data can be stored using paperless resources and the number of cloud based solutions on the market has become significantly larger, the electronic trial master file has emerged as one of the most relevant new developments in the world of clinical research and pharmaceutical technologies.   What is an eTMF?  The electronic trial master file, or eTMF, […]

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Practical Risk-Based Monitoring implementation tips

Risk-based monitoring is a hot topic right now. It is burning through lots of US and European events. So, the world is changing, is your company ready to embrace it? We can remind ourselfs about the times of numerous papers, faxes, Excel tracking, manual tracking, blue ink signatures, etc. It wasn’t that long ago. Looking into not that distant future we get to realize that RBM is something to accept […]

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Top eTMF related audit observations and preventive actions that work

  Speakers: Olga Loginovskaya, Chief Quality and Corporate Officer; Evgenia Mikhalchuk, Business Development Manager Date: May 17, 2016 Time: we will start at 04 PM, UTC+2 Duration: 45 minutes Agenda: How to efficiently deal with Lack of documents Undocumented site communication Lack of TMF regular review Validation documentation Audit trail and version control and other

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