21-cfr-part-11
(6)
Sware
Sware is a Boston-based software company that modernizes GxP validation for life sciences. Its cloud-native Res_Q platform and developer-focused GxPNext product use AI and a decade of regulated validation knowledge to automate the computer system validation (CSV) work that the FDA and other regulators require - helping pharmaceutical, biotech, medical device and CDMO teams cut validation time and cost while staying audit-ready. Formerly Boston Technology Research (BTR), the company rebranded to Sware in 2022 and has raised roughly $26-27M to date.
Ellen Reilly
Ellen Reilly is the Chief Executive Officer and a board member of Sware, a Boston-based software company building Res_Q, an AI-powered GxP validation platform for the life sciences industry. With roughly four decades in life sciences quality and IT, Reilly has worked at Roche, advised clients at PwC, and led the launch of DocuSign's Part 11 product before taking the helm at Sware in 2023. She frames her work as tackling 'validation debt' - the accumulated, unpaid cost of testing and compliance that slows how quickly pharmaceutical and biotech companies can adopt new software.
ClinCapture
ClinCapture is an eClinical software company that builds cloud-based tools for running clinical trials - electronic data capture (EDC), ePRO/eCOA, eConsent, randomization, medical coding, and trial master file management. Born from consulting firm Clinovo and once known as the only free, fully validated open-source EDC in the world, it now markets a unified, AI-augmented platform called Captivate that lets sponsors and CROs design, launch, and manage studies from a single validated cloud system.
Curebase
Curebase is a San Francisco-based eClinical software company building an AI-powered platform that runs clinical trials around patients' lives instead of inside hospital walls. Its single system spans study startup to database lock - combining electronic data capture (EDC), eConsent, ePRO/eCOA, patient recruitment, and a virtual research site model - so sponsors can launch decentralized and hybrid trials faster, capture cleaner data, and reach more diverse participant populations.
QbDVision
QbDVision is an Austin-based software company building the first cloud platform for Digital CMC (Chemistry, Manufacturing, and Controls), giving pharmaceutical and biotech teams a structured, single source of truth for product and process knowledge. By operationalizing Quality by Design principles, the platform replaces scattered documents and spreadsheets with connected, machine-readable data that accelerates drug development, tech transfer, and regulatory submissions. Founded in 2015 as CherryCircle Software, QbDVision now serves several of the world's largest biopharma organizations and CDMOs.
Medrio
Medrio is a San Francisco-based eClinical software company that helps pharma, biotech, medtech and diagnostics teams run clinical trials with a no-code, cloud-based EDC, eCOA/ePRO, eConsent and RTSM suite. Founded in 2005 and bootstrapped for more than a decade before taking outside capital, Medrio now powers thousands of studies across four continents.