Adhere to Firmer Study Archival Requirements with Egnyte's eTMF
Fines for Regulatory Noncompliance Keep Climbing
Fines and penalties for regulatory noncompliance within biopharma have been well documented. Since 2000, violations for noncompliance have cost biopharma $50B—and the costs of addressing root causes of noncompliance have grown as well, climbing by more than 40% since 2011 according to some estimates. The costs of remediating a deficiency can vary considerably, from as little as $250K to $5M for a Form 483 cited deficiency. With requirements like the EMA's 25-year eTMF retention rule, maintaining compliance is complex. But noncompliance can cripple growth.
Many biotechs face a dilemma: pay high CRO fees for archival or attempt implementing complex enterprise software themselves. Neither path is ideal.
Streamline your eTMF Management
At Egnyte, we understand the importance and the complexity of adhering to regulation. That’s why we have built solutions that are simple as they are compliant—including long-term study archival that adapts to lengthening duration requirements. Our inspection ready eTMF is built for your clinical trial needs:
Seamless eTMF Archival
Leverage the eTMF Exchange Mechanism Standard (eTMF-EMS) for straightforward import of the entire trial record without loss of data integrity. Avoid CRO lock-in and maintain control of your data.
With granular audit trails, e-signatures, and role-based access policies built-in, Egnyte provides inspection readiness out of the box.
“Egnyte’s eTMF unified these workflows into one cloud-based environment. When we receive a document, we can automatically assign the correct user. The user can go straight to the document, complete their tasks, and sign off, all within Egnyte and in an auditable, visible way.” - Luke Bogus, Product Manager, Vial
Purpose-Built for Your Environment
Egnyte’s eTMF application is part of Egnyte’s Life Science Platform, used by leading biotechs and CROs to manage, collaborate and govern their clinical documents and data. We designed our Life Sciences Platform with biotech's needs in mind.
Let us help you mitigate risk and maintain compliance. Schedule a consultation today.
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