Background

Three decades in clinical data —
from writing the rules to automating the work.

Clinventive is the practice of W. Stetson Line. It began on the vendor side, building the tools: research and product leadership at Provenda BioMetrics and at EDC pioneer Phase Forward — including an early electronic clinical outcome assessment (eCOA) system featured in a Microsoft case study.

Then the sponsor side, running the data: clinical programming and data management leadership at Genentech (where a paper on surfacing data changes for quality management took a PharmaSUG Best Paper award) and BioMarin, followed by a decade building and leading CDISC consultancy and implementation teams at Amgen and Exelixis. Along the way: founding and leading the CDISC SDS Conformance Rules team, authoring the rule set that evolved into today's CDISC CORE — work recognized with CDISC's 2017 award for Outstanding Contributions to Standards Development.

Clinventive, LLC was formed in June 2010 to carry that experience into independent practice. Today it consults on standards, programming, and submissions — currently under contract to a clinical-stage sponsor — and builds Verdatic, whose self-correcting approach to simulated study data was selected for presentation at the 2026 CDISC Interchange.

“I spent thirty years doing this work by hand. Verdatic is what that experience looks like as software.” — W. Stetson Line, President, Clinventive LLC
1996
Provenda BioMetrics
R&D / product
2001
Phase Forward
Engineering / product
2003
Genentech
CDM clinical programming
2008
BioMarin
Head of CDM
2010
Clinventive founded
independent practice
2011
Amgen
CDISC Consultancy and Implementation Head
2021
Exelixis
CDISC support services
Today
Verdatic
the practice, productized
Recognition & talks

On the record.

2026
Self-correcting simulation approach selected for presentation at the CDISC Interchange Entrant, CDISC AI Innovation Challenge
2019
“Synthetic Data and Predictive Data Modeling: Benefits in Driving Standards and Quality Outcomes” CDISC US Interchange (CDISC members) — making the case for synthetic data before the wave
2017
CDISC Award — Outstanding Contributions to CDISC Standards Development For founding and leading the SDS Conformance Rules team, precursor of CDISC CORE
Earlier
PharmaSUG Best Paper, Data Management · Microsoft case study on a pioneering eCOA system “Identifying and Surfacing Data Changes for Effective Quality Management” (Genentech) · Provenda BioMetrics era

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