Insights Blog

Bio-Optronics and Complion Announce Integration to Unify Best-in-Class CTMS and eRegulatory Solutions for Clinical Research Organizations

Posted by Complion on Nov 12, 2017 11:31:02 AM

Complion_BioOptronics_Partner.pngNovember 11, 2017 – ROCHESTER, NY – Bio-Optronics, the makers of the market leader Clinical Conductor Clinical Trial Management System (CTMS), and Complion, the powerful eRegulatory and document management platform for sites, have partnered to integrate their best-in-class solutions to deliver an industry-leading solution for research organizations.

The companies are building upon their long-standing commitment to meet customer needs and develop innovative solutions to empower investigative sites to run the world’s best research. This integration introduces a highly robust application suite, enabling research organizations to operate efficiently and profitably, while maintaining compliance with 21 CFR Part 11, HIPAA, and Good Clinical Practice (GCP).

Read More

Topics: eRegulatory, News, CTMS, Regulatory Compliance, Billing Compliance, Document Management

Tough decisions? See into your eRegulatory future at 2017 Global Site Solutions Summit

Posted by Abbie Hosta on Sep 12, 2017 12:43:33 PM

In life and in business, so many tough decisions would be so much easier to make if you only had the ability to see into the future. But in the real world, the best you can do is to draw on the experience of others who have faced similar critical decisions, learned what works and what doesn’t, and applied those lessons to shape your decision.

For most sites the transition to an eRegulatory system is not a matter of if, but when. Fortunately, you have a unique opportunity to draw on the experience of panel of professionals who have completed that transformation at the 2017 Global Site Solutions Summit, taking place October 6-8, 2017 in Boca Raton, FL.

Read More

Topics: eRegulatory, Events, Paperless Clinical Trials, Regulatory Compliance, Document Management

Q&A from Document Management Success: A Guide to Part 11 System Validation

Posted by Cristina Ferrazzano Yaussy on Aug 2, 2017 3:03:33 PM

The following is based on the Question and Answer portion of “Document Management Success: A Guide to Part 11 System Validation,” a Complion webcast featuring Michelle Grienauer, JD, MPH, Senior Regulatory Attorney at Kinetiq, and Cristina Ferrazzano Yaussy, MPH, CCRP, VP of Professional Services, Complion, Inc. The webinar explored what clinical research sites should know about validating eRegulatory and document management systems. 

366 individuals from the clinical research industry attended: 31% from an Academic Medical Center, 23% from a Hospital or Health System, 12% from a Dedicated Research Site, 11% from a Cancer Center, 7% from a Physician Practice, and 5% from a Sponsor or CRO. Prior to the webinar, the audience was polled to collect feedback about the current state of document management and validation.

Read More

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

How a Texas Cardiovascular Research Department Reached New Levels of Efficiency

Posted by Abbie Hosta on Jul 5, 2017 4:38:38 PM

It’s an increasingly common occurrence at clinical research sites, that moment of realization that the organization is choking on paper. A blizzard of documents and a mountain of bulging folders crushing efficiency and slowing processes to the point that a fleeting thought about a splash of lighter fluid and a well-placed match might pass through the mind of a harried site executive.

Cooler heads prevail, of course, and far less incendiary solutions are readily available.

Complion has been such a solution for a great many research sites, including South Texas Cardiovascular Consultants (STCC), a research hospital that serves patients in four locations throughout Texas.

Read More

Topics: Paperless Clinical Trials, Regulatory Compliance, Paperless Research Sites, Document Management

A Partner in 21 CFR Part 11 Compliance

Posted by Abbie Hosta on Jun 12, 2017 10:59:35 AM

How the right partner can smooth the path to a fully compliant regulatory and document management system

Efforts to transition to a streamlined paperless operation are unquestionably worthwhile. But the characteristic increases in efficiency are of little value if the transformed organization falls short of 21 CFR Part 11 compliance. That is why it is critically important that every step on the path to the paperless transformation is guided by professionals who are deeply, intimately familiar with the requirements for compliance.

Read More

Topics: Paperless Clinical Trials, Compliance, Regulatory Compliance, Paperless Research Sites, 21 CFR Part 11

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.

Read More

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

The Paperless Voyage: How Leading Sites Can Overcome Fear of Sponsor Resistance when Adopting an eRegulatory System

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 an eRegulatory system result in sponsor hesitation during site selection?

Read More

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

Steps to Paperless Research Sites: Creating Certified Copies & 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 Research Sites: 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.

Read More

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

Subscribe to Email Updates

Recent Posts

About Complion

Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

Contact Us