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Sourcia selects Flex Databases as eTMF provider

Sourcia, a full-service European CRO, has recently signed a contract for electronic Trial Master File implementation with Flex Databases. We’ve asked Claudia Gruber, Director Clinical Operations a couple of questions about the upcoming partnership: Why has Sourcia decided to pick Flex Databases as an eTMF provider? CG: To foster and allow for our continued growth, Sourcia decided to implement an eTMF system. After screening and testing of several eTMF systems […]

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Happy Clinical Trials Day!

Today is the day, dedicated to all of us who work in clinical trials – International Clinical Trials Day. Even though we are parted physically, for now, we are all together grateful for being a part of the industry. We praise the braveness and tirelessness of everyone, who is investing their precious time into finding the cure for every sickness in the world. Happy Clinical Trials Day!  

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How to move from a paper TMF to Flex Databases eTMF in three steps

One of the main factors stopping companies from moving to an eTMF is the actual moving process. When you think about transferring a ton of documents from paper to electronic, it usually seems to be just an impossible work. With Flex Databases eTMF all you need to move from paper to electronic Trial Master File is three simple steps: Set up your Flex Databases eTMF e-mail address as a receiving point […]

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How eTMF saves money

When we ask our clients why they’ve decided to implement one or another system, among many reasons, we always have something budget-related – it might be financial transparency, cost-effectiveness, and other variations. Financial transparency is a big subject that we will cover soon in a separate article, but today is for cost-effectiveness, and specifically for how exactly Flex Databases eTMF saves money. Here’s the list: Physical storage: paper TMF requires […]

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How we’ve moved to remote: challenges, solutions and findings

Over a month ago, we at Flex Databases moved our employees to work from home due to a pandemic outbreak. We have met challenges, part of which are solved, and some are still ongoing. The situation is going to develop further, but the time has come to take a deep breath and review where we are. Challenges & solutions: Challenge #1: Potential productivity drop Multiple pieces of research show a […]

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How we implement Flex Databases system

We can deliver a fully functional system in the timeframe from 3 to 10 (typically around 5) weeks, depending on the Client’s involvement and complexity of the Client’s requirements. Here’s how the implementation process goes:   As clearly is shown and was previously mentioned, the Client is an important part of the implementation process. With the right approach to implementation on the Client side and our optimized implementation flow, we […]

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What’s new in Flex Databases Application Release 11

Trial Master File 6.0 OCR recognition: Upload scanned documents and pictures in TMF and make them searchable. System supports automatic text recognition on upload or single file recognition in more than 8 languages Digital sign-off function for documents: assign authors, reviewers, and approvers, upload documents for digital sign-off. The system creates a document with a digital signature page My favorites: Mark frequently used files as Favorites. Browse and have them […]

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Trial Master File: paper vs eTMF

Electronic Trial Master File or eTMF is not a new thing on the market, yet there are still companies working with paper solutions. Of course, every single eTMF provider now has a “Now it’s time to change to eTMF because it’s online” kind of article, but we at Flex Databases believe, that eTMF is more than just cloud storage. Flex Databases offers migration from paper to digital in 5 weeks. […]

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FDA has released the Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic

Yesterday morning FDA has released the Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic. Here are the parts of Guideline recommendations that may be successfully followed with Flex Databases system: Protocol deviations and IRBs/IEC submissions tracking The Guideline states, that “FDA recognizes that protocol modifications may be required and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures.”  In […]

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How CRA Activity Management impacts daily life of a CRA

If we imagine clinical trials as a human body, Clinical Research Associates would be the blood cells. They travel a lot across the whole organism, delivering data oxygen to all organs and body parts. If something stops the proper functioning, it may result in global failure. That’s the reason why we developed CRA Activity Management module – to help our clients ensure and support the proper CRA’s functioning.  From hours […]

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