|Articles|February 1, 2008

Applied Clinical Trials-02-01-2008
Volume 0
Issue 0

eShowcase: Company Introduces and Validated Products

EDC 4.1 System Goes Through Paces; Document Management Announced

EDC 4.1 System Goes Through Paces; Document Management Announced

Octagon Research Solutions (Wayne, PA) recently completed its 140-point user requirements validation of its ViewPoint FUSE EDC 4.1 platform. These requirements were related to 21 CFR Part 11 compliance; management of sites, subjects, and case books; data entry and review processes; edit checks; and manual- and system-generated queries.

The company also announced its ViewPoint for Document Management, a solution combining document management, authoring templates, document standards, and expert guidance. It is offered in two models: a traditional install/implementation and a new hosted model that eliminates installation, hardware, and validation costs in favor of a direct connection to Octagon resources.

Octagon Research Solutions, (610) 535-6500, www.octagonresearch.com

Articles in this issue

almost 19 years ago

Article

How Technology Could Change Drug Approvals

almost 19 years ago

Article

India Benefits from SMO Presence

almost 19 years ago

Article

Pharmacovigilance: A Company-Wide Challenge

almost 19 years ago

Article

Advertising Exhibitors Gallery

almost 19 years ago

Article

eShowcase: Web Submission Data Manager Updated

almost 19 years ago

Article

Limited Resources Undermine FDA

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

Related to this article

November 9th, 2026

AI Can Draft the CSR Faster, But Does That Make Drug Development Faster?

AI can draft a CSR in minutes, but the report only reflects evidence that has already converged, so faster drafting shifts the bottleneck to upstream reconciliation, database-lock readiness, and human accountability rather than shortening the trial itself.

November 9th, 2026

How China Cut Its Phase III Startup Timeline and What Drove the Change

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, details how NMPA reforms, parallel reviews, and expanded reviewer capacity brought China’s startup timelines in line with the US and Europe, and could shorten them further.

November 9th, 2026

ACT Brief: APAC Inspection Findings, RBQM Key Risk Indicators, and Head and Neck Cancer Approval

In today’s ACT Brief, we examine why APAC inspection findings mirror those in the US and Europe, how key risk indicators should be read together, and how FDA granted accelerated approval to a subcutaneous antibody therapy for recurrent head and neck cancer.

November 6th, 2026

What FDA Inspections Reveal About the Quality of APAC Clinical Trial Sites

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how FDA inspection findings at APAC sites compare with those in the US and Europe, and why the common issues, such as informed consent versioning, are not unique to the region.

November 6th, 2026

ACT Brief: Asia Pacific Site Perceptions, Community Access Gap, and VeonGen Gene Therapy Alignment

In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site infrastructure, and how VeonGen has aligned with the FDA on a pivotal gene therapy trial design.

Ten key risk indicators can flag recurring good clinical practice problems in noncompliance, safety, data quality, and oversight, but only when normalization, trial timing, and combined signals are taken into account. Credit: Stock.Adobe.com/Andrey Popov.

November 6th, 2026

The 10 Most Powerful Study KRIs in RBQM and GCP Issues They Can Prevent

Risk-based quality management depends on knowing what to monitor and on interpreting what the signals mean.

November 5th, 2026

Why Outdated Perceptions of APAC Clinical Trial Sites Persist Among Smaller Biotechs

In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how regulatory reform and inspection data contradict the view that APAC sites are slower or lower quality, and why sponsors need to update their assumptions.

November 5th, 2026

Closing the Community Access Gap: Q&A with Kent Thoelke, Paradigm Health

In this Q&A, Kent Thoelke, CEO of Paradigm Health, discusses why participation gaps in community and rural settings come down to both patient cost barriers and site infrastructure, how legacy workflows weigh on community clinics, and what policy and technology changes it would take to make clinical research a real care option for more patients.