The Complete Library of FDA eSource and eRegulatory Guidance
Over 400 pages answering 150+ questions sites have asked the FDA about using eRegulatory and eSource in clinical research.
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Compliance
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FDA 21 CFR Part-11 Compliance Checklist
Read our extensive checklist on everything you need to consider regarding FDA 21 CFR Part-11 compliance for clinical trial electronic document management and workflows.
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Understanding Data Privacy: Three Key Concepts for Your Clinical Trials
Personal data privacy is not a new concept when it comes to healthcare. In fact, the right to privacy hasn’t changed in over 130 years. In the mid-1990s, when the utility of the Internet was in...
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Beginners Guide to the California Consumer Privacy Act (CCPA)
Learn about what the CCPA affects and the role both consumers and businesses play within this regulation.
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Beginners Guide to Global Data Protection Regulation (GDPR) for Clinical Trials
Wondering how GDPR affects the clinical trial industry? Check out the tips for complying with GDPR that we've gathered based on our experience working with European clinical research sites.
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Ten Tips for Launching eSignatures in Clinical Trials While Avoiding Part 11 Risks
Is your eSignature strategy compliant? We've compiled ten tips for launching eSignatures in clinical trials while avoiding Part 11 Risks.
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Compliance Through Lens Of Global Clinical Research Breakdown
Learn the essentials of going global in a clinical trial.
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Data Protection Flash Cards
Use these flashcards to understand and effectively navigate data protection regulations and ensure that your organization has a strong data protection plan.
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Clinical Trial Data Privacy and Protection Tips (Including GDPR)
Tips for Managing Data Protection and Data Privacy in Clinical Trials Technology continues to play a larger role in clinical trials, and subsequently, regulatory bodies are placing intense...
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How Remote Monitoring Increases Regulatory Compliance for Your Studies
How Remote Monitoring Increases Regulatory Compliance for Your Studies This article was originally published on PharmaLive.com by Andrea Bastek, Director of Innovation at Florence. The rapid...
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Case Report Form Repository for Clinical Trials
Gathering and securing data throughout the lifecycle of a clinical trial is of utmost importance in order to preserve study integrity. To facilitate this collection of critical data, researchers...
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FDA: Technology’s Value in a World of Precision Medicine and Research
Over the course of the past 10 years, significant advancements have been made in clinical research. Personalized medicine, immunotherapies and genomic testing have equipped researchers with the...
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ALCOA-C in Clinical Trial Electronic Document Management
Good documentation is vital to good clinical research. As the saying goes, “If it isn’t documented, it doesn’t exist”. In fact, one of the most common inspection findings in investigator site...
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How to Avoid the Top 5 Clinical Trial FDA Inspection Failures
Your heart begins beating faster and sweat begins forming on your forehead - the FDA is calling. Many things can trigger an FDA inspection - most falling into routine study-related visits, while...
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How to Use Electronic Signatures (eSignatures) in Clinical Trials
Electronic signatures, eSignatures, are continuing to gain momentum replacing wet signatures in Clinical Trials. Wet signatures are signatures made by hand on a document, typically with a pen and...
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