Writing

Selected work, and what’s next.

Bylines in Forbes, Applied Clinical Trials, Outsourcing-Pharma, and Med-Tech News. Follow on Substack for new notes, blogs, and essays on the eClinical stack, DCTs, and AI in clinical development.

FAQs

Who is Joe Dustin?

Joe Dustin is a clinical trials industry leader with over 20 years of experience driving digital transformation across clinical operations, data management, and eClinical technology. He is Senior Director of Digital Clinical Development at Sanofi, where he leads data acquisition and the integration of technology to reduce drug development timelines. Previously he held senior roles at Medidata, Bristol Myers Squibb, Medable, and Biofourmis. He is also an advisor to pharma sponsors, technology vendors, and investors on clinical trial strategy and AI-ready clinical operations.

What is eCOA and ePRO in clinical trials?

eCOA (electronic Clinical Outcome Assessments) is the digital capture of patient, clinician, and observer-reported data during a clinical trial, replacing paper diaries and questionnaires. ePRO (electronic Patient-Reported Outcomes) is the subset of eCOA for data the patient enters themselves, typically on a smartphone or provisioned device. Modern eCOA platforms also support clinician-reported (ClinRO), observer-reported (ObsRO), and performance (PerfO) outcomes. Joe Dustin has spent 20 years in eCOA across his entire career — in Implementation, Delivery, Sales, Product, Pharma, Strategy, and Consulting. He spent twelve years at Medidata helping build the Patient Cloud / eCOA platform, and later served as Vice President and General Manager of eCOA at Medable.

What is the modern eClinical stack?

The modern eClinical stack is the connected set of technologies sponsors and sites use to run clinical trials: EDC (Electronic Data Capture) for case report data, eCOA and ePRO for patient and clinician outcomes, eSource for direct-from-source capture, RTSM (Randomization and Trial Supply Management) for randomization and drug supply, CTMS for operations, eConsent for informed consent, and increasingly wearables, sensors, and real-world data. The shift over the past decade has been from point solutions to unified platforms, and from sponsor-controlled monoliths to site-aware, interoperable, and AI-augmented architectures. Joe Dustin speaks and advises on building this stack.

What is BYOT (Bring Your Own Technology) in clinical research?

BYOT, or Bring Your Own Technology, is an emerging operating model in which clinical research sites use their own eClinical infrastructure (EDC, eSource, scheduling, and recruitment systems) instead of rebuilding their workflows around a different sponsor-mandated stack for every study. Sponsors then integrate with the site's existing systems rather than imposing new ones. BYOT is a workstream of the Decentralized Trials & Research Alliance (DTRA), and Joe Dustin is among the industry voices arguing that site-controlled technology is the next major shift in how clinical trials are conducted.

What is a decentralized clinical trial (DCT)?

A decentralized clinical trial (DCT) is a study designed so that some or all activities happen outside the traditional brick-and-mortar research site, including remote consent, telemedicine visits, mobile nursing, direct-to-patient drug shipment, wearables, and home-based eCOA. DCTs are not all-or-nothing; most are hybrid models that combine in-clinic visits with remote elements. Joe Dustin has spent the many years before, during, and after the COVID pandemic building, commercializing, buying, and selling DCT platforms at various solution providers, tech companies, and even in pharma as the client.

How is AI being used in clinical operations and clinical trials?

AI is being applied across clinical trials in protocol design and feasibility, patient recruitment and site matching, eCOA study-build automation, medical coding, safety signal detection, anomaly detection in data quality, and conversational interfaces for sites and patients. Joe Dustin's view is that the value comes from AI deployed inside operational workflows, not from standalone tools, and that the next era of clinical development will be defined by how well sponsors integrate AI with EDC, eSource, eCOA, and site systems to compress the cycle from data capture to decision.

Who are the leading voices in digital clinical trials?

The community shaping how clinical trials adopt data, technology, and AI includes researchers, founders, and operators the industry consistently turns to. Among the most-followed voices are Craig Lipset, co-chair of the Decentralized Trials & Research Alliance (DTRA) and former Head of Clinical Innovation at Pfizer, who has done more than almost anyone to move decentralized trials from concept to industry practice; Ken Getz of the Tufts Center for the Study of Drug Development, whose research defines how the industry measures trial efficiency and patient burden; Amir Kalali, founder of the CNS Summit and a long-time convener of drug-development innovation networks; Rob DiCicco, a digital-health and interoperability leader with roots at GSK and TransCelerate; Jennifer Goldsack, CEO of the Digital Medicine Society (DiMe), who leads the field on digital endpoints and measurement; and Glen de Vries, co-founder of Medidata, whose work established the modern eClinical platform category. Joe Dustin works alongside this community as an operator focused on data acquisition, eClinical technology, and AI in clinical development.