Resources

Compliance and Regulatory

Latest Compliance and Regulatory Resources

Build or Buy a CTMS: Consider Data Security

Ask these three questions to ensure a clinical trial management system can support privacy and security of data.

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Reference Guide – Popular FDA Regulations in Clinical Research

Stop searching and use this help sheet to find the most referenced regulatory time requirements for Investigators and Sponsors of medical device research.

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Medicare Coverage Analysis in Oncology Trials: 3 Key Challenges

Address these three challenges and avoid clinical trial billing non-compliance with a Medicare Coverage Analysis.

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Onsemble Conference Review: Effort Tracking, 21 CFR Part 11, More

A quick review of popular session topics and resources for learning more.

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Conducting Clinical Research Billing Audits

A popular webinar hosted by Forte is available to view online.

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Creating a Culture of Research Compliance Through Prevention

Beverly Ginsburg-Cooper of the Huron Consulting Group explains how a preventive approach can promote compliance throughout an organization.

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Assessing Common Challenges in Clinical Research Billing Audits

Ryan Meade, of Aegis Compliance & Ethics Center, LLP, discusses top challenges associated with conducting clinical research billing audits.

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The Physician Payment Sunshine Act: FAQs

Ryan Meade, of Aegis Compliance & Ethics Center, LLP, answers questions posed during his recent webinar on the Physician Payment Sunshine Act.

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Building a Successful Clinical Research Billing Initiative

Decrease your risk of non-compliance.

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Disclosure Requirements for ClinicalTrials.gov: Your FAQs Answered (Part 2)

Barbara Godlew, of The FAIRE Company, LLC, answers your questions related to ClinicalTrials.gov. This is the second part of a two-part series.

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