Resources

Compliance and Regulatory

Latest Compliance and Regulatory Resources

21 CFR Part 11: Vendor vs. Sponsor Responsibilities

Join us for this webinar as Shannon Roznoski of Forte Research Systems discusses the roles both sponsors and vendors play during the validation process of an EDC system.

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IRB and Social Media: 5 Misunderstood Regulations to Help Your Site Recruit Patients Faster

During this presentation, Matt Miller of StudyKiK will discuss strategies for keeping your social media efforts both compliant and effective.

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The What, Why and How Behind Records Review Protocols

Join us for this informative webinar to learn what records review protocols are, why they’re important, and how to conduct them.

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Preparing for an FDA Audit? Learn How.

While FDA audits are fairly common, many researchers haven’t been through them yet. Learn what it takes to be prepared for your next audit.

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Is Your Site FDA Inspection-Ready?

Madeleine Williams and Roberta Costello will present practical tips for preparing for your next FDA audit, including real-world examples.

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The Pharmaceutical Industry According to Google Autocomplete

Are you curious what people are searching about the pharmaceutical industry? Google Autocomplete provides some insight into pharma’s reputation problem.

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The Global Future of Clinical Trials for the Medical Device Industry

London-based CRO, Richmond Pharmacology, shares what’s next for the medical device industry, including testing, licensing, and monitoring worldwide.

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Do SOPs for Data Collection Equal Compliance with 21 CFR Part 11?

Anders Lindquist clears up common confusion surrounding standard operating procedures and 21 CFR Part 11.

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Clinical Research Billing: How far back do you need to audit?

Learn how far back you need to look when conducting clinical research billing audits and why, as well as what changes may be coming down the road.

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Q&A: What You Need to Know to Prepare for an FDA Audit

Madeleine Williams of Huron Consulting Group answers some questions from her recent webinar, What You Need to Know to Prepare for an FDA Audit.

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