|Articles|August 1, 2007

Applied Clinical Trials-08-01-2007
Volume 0
Issue 0

eShowcase: WebSDM

Hosted Service Offering Validates Data Prior to FDA Submission to Improve Review Process

Hosted Service Offering Validates Data Prior to FDA Submission to Improve Review Process

Phase Forward (Waltham, MA) announces a new submission checking service based on its Web Submission Data Manager (WebSDM) application. The hosted service offering produces a comprehensive report detailing all errors identified by WebSDM. Following the report, Phase Forward's CDISC specialists conduct an interactive review session using the customer's data and the same review capabilities that FDA uses.

WebSDM gives organizations a way to test FDA submissions for compliance with the CDISC Study Data Tabulation Model (SDTM) standard for human clinical trials. The Submission Checking System makes WebSDM data validation services broadly available as a hosted service, which enables organizations to quickly confirm if the data from trials conforms to SDTM standards to reduce possible delays from FDA data-related queries.

The service is available now, and current customers can convert to a license for ongoing studies.

Phase Forward, (781) 890-7878, www.phaseforward.com

Articles in this issue

over 19 years ago

Article

New Policies to Increase Information on Trials

over 19 years ago

Article

Laying with the Lions

over 19 years ago

Article

From Cradle to Grave

over 19 years ago

Article

Software Decisions and Opportunity Costs

over 19 years ago

Article

Sponsors: PAY HEED

over 19 years ago

Article

Preparing for Europe's Pediatric Rules

over 19 years ago

Article

Patient Registry Strategies

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In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site infrastructure, and how VeonGen has aligned with the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

November 5th, 2026

ACT Brief: Capturing Trial Friction, AI Matching Model Comparisons, and Boehringer’s Oncology Deal

In today’s ACT Brief, we examine how capturing friction in real time can reveal site burden, how OpenAI and Mistral compare on clinical trial matching, and how Boehringer Ingelheim is licensing early-stage oncology programs from SBP Group.

November 4th, 2026

Comparing OpenAI and Mistral on Clinical Trial Matching

Mistral and OpenAI produced identical overall eligibility labels across 200 synthetic patient-study assessments, with criterion-level disagreements concentrated in inclusion criteria where models switch between “Uncertain” and “Not included” when records lack sufficient evidence, so model choice should be driven by deployment architecture, control, and cost rather than assumed interchangeability.

November 4th, 2026

The Human Side of Clinical Trials: Before Burden Becomes Risk, Capturing Friction in Real Time

In Episode 4 of The Human Side of Clinical Trials, host Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., speaks with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about how capturing friction closer to the moment it happens can reveal unclear instructions, technology friction, and workarounds that retrospective surveys and debriefs tend to miss.