e-FAST automated the conversion of paper CRFs and their supporting clinical metadata into FDA submission-compliant format.
At Biohaven, my small portion was keeping the clinical data flowing so the trials could be run and the data could be collected, analyzed, explained, and submitted.
80%reduction in CRF processing costs for Pfizer’s GCO
Human + machine
Dividing the work between people and computers.
I designed a human-computer collaborative process for algorithmic trading systems making real-time streaming decisions within 28 microseconds of receiving input.
Seasoned Global Clinical Operations (GCO) IT professional with > 20 years’ experience designing processes and building the technologies support all things data.
Enjoying a career-long learning experience where success requires me to be working closely, and holistically, with multitudes of disparate Stakeholders.
I also speak Clinical, Quality, Regulatory, Study Start Up, Real-World-Data, Procurement, Data Governance, Medical Writing, Submissions, Operational Data Analysis, Health Authority Inspections, Learning, Manufacturing, Marketing, Vendor, Process, CRO, CTMS, eTMF, IQ, OQ, PQ, CFR, CRF, PHI, you get the picture.
Bringing common language across stakeholder communications leads to a more harmonious and efficient experience.