MES3 Consulting helps regulated organizations bring order to clinical data, the systems that run on it, and the processes connecting them — from governance and engineering to the automation and AI that make it faster, built to hold up under scrutiny, not just look good in a slide deck.
Each engagement starts wherever the gap actually is — the data, the software, the compliance record, or the process holding them together.
Trial setup, eCRF design, patient enrollment forecasting, and safety and compliance data — the operational backbone of a running trial.
Validated executive dashboards, SQL and Oracle-based reporting, and data repositories built to turn raw records into decisions people trust.
GxP and FDA-compliant systems, validated through a risk-based Computer Software Assurance (CSA) approach — full IQ/OQ/PQ where the risk warrants it, right-sized assurance everywhere else.
Hands-on implementation and ongoing support across SAGE, NetSuite, and adjacent systems — from initial configuration through the support tickets that come after go-live.
Requirements gathering, process mapping, and project delivery for digital transformation initiatives — the connective tissue between what the business needs and what the system does.
Automating the workflows that carry the greatest time and risk exposure — with a demonstrated record of reducing data-collection cycles from nine weeks to three, and applying that same rigor to identify where AI can responsibly streamline operations today.
Map the current state of the data, systems, or process in question, and where it's breaking down.
Define the target state and the governance or system changes needed to get there.
Execute the change directly — configuration, documentation, or process rollout.
Confirm the result holds up against the standard it needs to meet, audit included.
MES3 Consulting is run by Rafael Mestre, a consultant with a background in clinical data governance, ERP systems, and business systems analysis and project management.
That background spans ERP implementation and support work — including SAGE and NetSuite — alongside business systems analysis, project management, and client-facing consulting for organizations that can't afford ambiguity in their data or their systems.
Based in the Los Angeles / Ventura County area of California, and working with organizations in regulated industries where governance isn't optional.
Share a brief overview of the challenge you're facing — whether it involves data integrity, system performance, or process inefficiencies — and I will follow up directly to discuss how MES3 Consulting can help.