Insights

Complion Article Featured in ACRP’s Flagship Journal, Clinical Researcher

Posted by Abbie Hosta on Apr 5, 2017 10:52:17 AM

Complion is honored to have recently published an article in Clinical Researcher, the peer-reviewed flagship publication of the Association of Clinical Research Professionals (ACRP).

Clinical Researcher is published six times a year and features articles on the latest developments across the spectrum of specialty areas in the clinical research enterprise, as well as highlighting valuable insights and resources from columnists, internal and external news sources, and the Association’s partner organizations.

Written by Complion VP of Professional Services Cristina Ferrazzano Yaussy and Oklahoma Heart Hospital Senior Director James Wetzel, Ensuring Compliance with Part 11: A Site's Perspective focuses on best practices for maintaining maximum efficiency while meeting the challenges of Part 11 compliance.

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Topics: News, Compliance, Regulatory Compliance, 21 CFR Part 11

The Paperless Voyage: How Leading Sites Can Overcome Fear of Sponsor Resistance

Posted by Lisa Bozza Archer on Mar 28, 2017 4:18:26 PM

The paperless trend is sailing across the industry and continues to gain momentum. While electronic document management is becoming more mainstream in research, it is still considered uncharted territory for some sites and a voyage for others.

Some sites approach this change with trepidation, fear, and questions. Will their sponsors accept documents signed electronically, or will they balk at the mere suggestion? Will monitors resist reviewing site documents electronically? Or, worst of all, will adopting electronic document management result in sponsor hesitation during site selection?

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Topics: eRegulatory, Paperless Clinical Trials, Regulatory Compliance, Paperless Research Sites

Steps to Paperless Clinical Trials: Creating Certified Copies and More

Posted by Abbie Hosta on Mar 20, 2017 3:13:39 PM

Whether you’ve taken the first steps toward a paperless clinical trial environment, or are still contemplating that very important transformation, you will want to take advantage of a new resource now available from Complion.

Steps to Paperless Clinical Trials: Creating Certified Copies and More, a new Complion feature article, presents insight and expertise from Betsy Fallen on using information technology to tame the paper beast that threatens efficiency and productivity at clinical research sites.

A recognized authority on the role of IT in regulatory and clinical operation and data management, Betsy’s early training as a registered nurse has kept her focus on patient welfare throughout her career. Now a regulatory and clinical process consultant, Betsy spent several years in regulatory and clinical operations with Merck and Co., along the way accumulating expertise in moving clinical trials to paperless environments.

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Topics: Paperless Clinical Trials, Regulatory Compliance, Paperless Research Sites, Certified Copies

FDA Inspections Need Not Be Stressful: A Q&A With Dr. Harvey Arbit

Posted by Complion on Aug 2, 2016 2:07:55 PM

The following is based on a transcript of the Question and Answer portion of “FDA Inspections Need Not Be Stressful,” a Complion webcast featuring Dr. Harvey Arbit, PharmD, MBA, RAC, CCRP. Dr. Arbit is the president of Arbit Consulting, and is an adjunct professor at the University of Minnesota College of Pharmacy.

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Topics: Regulatory Compliance, FDA Inspections