About the founder, Ellen Stewart
For more than 25 years I watched clinical data managers, including myself, transcribe the same information from protocols into database specifications, CRFs, and data transfer agreements. Over and over, study after study. Meticulous, time-consuming, and to be candid, mentally dulling work at times. I'd sit there thinking, “there has to be a better way”.
Now there is.
Our industry has reached a turning point. Standards and technology are finally converging to automate the manual work that has consumed clinical development teams for decades. The Unified Study Definition Model, ICH M11, and solutions are rapidly evolving, making it possible to define a study once, in a structured, machine-readable format, and have that definition flow automatically into every downstream system: your EDC, CTMS, SDTM, regulatory submission documents, and many other use cases.
Yet most organizations still haven't made this shift. The knowledge gap is real, and the path forward isn't always clear.
I launched AdoptDigitalData to help close that gap, particularly for emerging biopharma and biotech companies who often lack the internal resources to navigate this transition on their own.
My Journey into Digital Data
A few years ago, I kept hearing about the promise of "building the EDC database in a day" and decided I needed to understand if and how that was possible. I followed that curiosity deliberately, diving into websites, webinars, certified training, and learning in the industry forums and working groups advancing this initiative. I learned that while ‘building the EDC in a day’ isn’t yet the norm, timelines can be reduced significantly when the protocol is expressed in structured, machine‑readable formats.
What I found was energizing. The industry has made remarkable progress toward true digital data flow, and the community driving it forward is collaborative, open, and genuinely mission-driven. I'm a CDISC individual member and plan to deepen my involvement in this space alongside my consulting work.
At a certain point, the depth of understanding I'd built felt like something I could bring to others — organizations trying to figure out where to start, what it means for their team, and how to move forward with confidence. That's when AdoptDigitalData was born.
Disclaimers
Digital Data Flow (DDF) is an industry initiative advanced by TransCelerate Biopharma, in collaboration with other organizations including CDISC. AdoptDigitalData is an independent consultancy and is not affiliated with or endorsed by TransCelerate. You can read more about the work done by TransCelerate and CDISC on the DDF Resources page.
My guidance is vendor-agnostic. I have no financial affiliation with any marketed technology vendor or solution. My role is to help organizations identify their pain points and business needs, so that when it comes time to evaluate SaaS vendors or DDF-enabled CROs, the decision is informed, objective, and grounded in what's right for your organization.
Currently AdoptDigitalData is a one-person consulting enterprise. However, the business may expand in the future.
AdoptDigitalData is the DBA consulting arm of FlexCDM LLC, providing fractional Clinical Data Management leadership to small pharma and biotech firms.