CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a provider of breakthrough software and services to the life sciences industry, today announced that Octagon will be exhibiting at the Drug Information Association's (DIA) 7th Annual Electronic Submissions Conference.
OCTAGON RESEARCH SOLUTIONS, INC. TO EXHIBIT AT THE
7TH ANNUAL ELECTRONIC SUBMISSIONS CONFERENCE
Octagon’s Vice President, Regulatory Affairs, to Present in Multiple Tracks
(WAYNE, PA, October 30, 2008) — CEO & Chairman Jim Walker <http://www.octagonresearch.com/management-team.html> of Octagon Research Solutions, Inc. <http://www.octagonresearch.com/> , a pioneer and leading provider of breakthrough software and services to the life sciences industry, today announced that Octagon will be exhibiting at the Drug Information Association’s (DIA) 7th Annual Electronic Submissions Conference. The conference will be held at the Westin San Diego located at 400 West Broadway, San Diego, California from November 5-7.
Octagon’s Vice President, Regulatory Affairs, Nancy Smerkanich <http://www.octagonresearch.com/employees.html#nancy> , will be presenting and chairing in several sessions during the conference. Ms. Smerkanich has over 24 years of professional experience in Regulatory Affairs. She is recognized for her experience and expertise in preparing and maintaining electronic Submissions. Ms. Smerkanich is also a frequent presenter at industry conferences world-wide and is the co-chair of the eCTD subgroup under the DIA Electronic Regulatory Submissions SIAC.
Ms. Smerkanich first presentation entitled, “eIND Submissions,” is scheduled for Wednesday, November 5th from 8 a.m.-12 p.m. PST. This presentation will discuss the practicalities and processes of creating and maintaining IND applications in the eCTD format. She will also be chairing and speaking at a session entitled, “The Switch to eCTD (Case Studies) /Getting Started,” which is scheduled for Thursday, November 6th, from 1:30 p.m. - 3 p.m. PST. This session will discuss how small biotech, midsize pharmaceutical and big Pharma organizations “made the switch” to eCTD.
Octagon will be exhibiting at Booth #5, and demonstrating two of its integrated solutions, ViewPoint®Quantum <http://www.viewpointquantum.com/> and ViewPoint®FUSE <http://www.octagonresearch.com/viewpoint-fuse.html> . ViewPoint Quantum is Octagon’s new Accelerated Publishing platform that offers a comprehensive solution where authors, publishers and anyone contributing to a process, can interact in a secure and collaborative environment. The ViewPoint Quantum platform is founded on an enterprise process management engine that provides comprehensive process management controls across various business applications.
ViewPoint FUSE provides a user-friendly, web-based access to efficient data capture capabilities. Combined with Octagon’s process and technology integrations, ViewPoint FUSE has the ability to promote enterprise level data standardization across the clinical data lifecycle.
If you would like to learn more about Octagon, please contact Octagon Research Solutions, Inc. at 610-535-6500 or visit our website at www.octagonresearch.com <http://www.octagonresearch.com/> .
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Berkhamsted, UK. Octagon’s EDC Operations are located in Mountain View, CA. For more information please visit www.octagonresearch.com <http://www.octagonresearch.com/> .
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.