Compliance and Regulatory Requirements in Clinical Research

Regulatory compliance in clinical research including FDA requirements and guidelines.

[Q&A] Regulatory Considerations for Patient Recruitment

January 31st, 2017 by Dr. Wendy Tate

Co-presenter, Dr. Wendy Tate, addresses attendee questions following Forte's recent webinar on advertising clinical trials for patient recruitment.

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Participating in Qualifying Clinical Trials? Implement These Best Practices to Ensure Compliance

January 5th, 2017 by Kayla Leverton

Billing compliance can be particularly difficult for clinical research sites participating in qualifying clinical trials. Use these tips to decrease your risk for non-compliance and gain the revenue you rightfully earn.

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[Q&A] Risk-based Validation Considerations When Implementing Clinical Research Systems

August 25th, 2016 by Susan Nonemaker-Cox

Susan Nonemaker-Cox of Essex Management answers attendee questions following her recent webinar on risk-based validation considerations.

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Must-Have Apps for Clinical Research Professionals

August 11th, 2016 by April Schultz

Free apps for clinical research professionals to prevent trial deficiencies and improve research practices.

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AACI-CRI Day One: Making Strides Towards Streamlined Clinical Trials

July 21st, 2016 by Dr. Wendy Tate

AACI-CRI meeting attendees discuss methods for increasing efficiencies in clinical trials, including feasibility committees and workload assessment.

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Making Your Consent Forms Readable: The Why and the How - Q&A

June 29th, 2016 by Dr. Wendy Tate

In this Q&A, Dr. Wendy Tate of Nimblify, Inc. answers attendee questions from her webinar "Making Your Consent Forms Readable: The Why and the How." Question topics include NPRM, federal regulations, cost language, central IRBs and more.

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HIPAA: Reflecting on the Past and Preparing for the Future

June 21st, 2016 by PFS Clinical Staff

An exploration of how HIPAA has shaped the healthcare industry, and speculations on how the law will meet growing digital health concerns.

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[Q&A] Making the Most of Your Budget: Hidden Costs and Payment Terms

June 2nd, 2016 by Amanda Miller and Alexandra Opitz

In Making the Most of your Budget: Hidden Costs & Payment Terms, seasoned clinical trial analysts Amanda Miller and Alexandra Opitz discuss the basics of clinical trial budgeting, how to handle hidden costs with the study sponsor, and how to make payment terms work for your institution.

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Biobanking in a Global Society: Awareness of International Laws & Guidance

May 19th, 2016 by Dr. Wendy Tate

Director of Data Analytics, Wendy Tate, discusses the changing regulatory environment of biobanking research and foreseen revisions to guidance documents.

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[Q&A] How to Prepare for an FDA Inspection

May 17th, 2016 by Madeleine Williams and Roberta Costello

Webinar presenters Madeleine Williams and Roberta Costello answer attendee questions about FDA audit topics, such as Good Clinical Practice, PI availability, PI oversight and more.

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