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.
Read Flipbook
Over 400 pages answering 150+ questions sites have asked the FDA about using eRegulatory and eSource in clinical research.
Read Flipbook
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.
Read Flipbook
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...
Read Blog
Learn about what the CCPA affects and the role both consumers and businesses play within this regulation.
Read Flipbook
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.
Read eBook
Is your eSignature strategy compliant? We've compiled ten tips for launching eSignatures in clinical trials while avoiding Part 11 Risks.
View Infographic
Learn the essentials of going global in a clinical trial.
View Infographic
Use these flashcards to understand and effectively navigate data protection regulations and ensure that your organization has a strong data protection plan.
View One Pager
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...
Read Blog
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...
Read Blog
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...
Read Blog
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...
Read Blog
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...
Read Blog
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...
Read Blog
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...
Read Blog