Clinical ResearcheClinical Systems Consulting
IRT, RTSM, and clinical supply systems, advised by someone who built them.
Choosing a vendor, building a study, running UAT, or getting more out of the system you already have: we bring twelve years on the vendor side of IRT and RTSM, and a client base that runs from small biotechs in the San Francisco Bay Area to top-3 pharmaceutical companies around the world, to your side of the table. The decisions are yours and the surprises are fewer.
What we do
We offer seven ways to engage, from an end-to-end systems assessment to a senior person on retainer. Each one ends with a written deliverable.
Clinical supply chain systems assessment
An end-to-end look at the systems your clinical supply function runs on: structured interviews across the function, a current-state map of applications against business capabilities, the gaps and boundary systems an ERP or planning migration will expose, peer benchmarking, and a roadmap that sequences the migration and the AI adoption on top of it. This is the largest engagement we run, and the one the others grow out of.
Vendor selection and RFP support
Requirements that reflect how your studies actually run, a category search across the IRT/RTSM and clinical supply vendors, scored demos, and a recommendation your procurement and quality groups can both sign. We have sat on the other side of the table for a decade, so we know which claims to test.
Implementation and study build oversight
Sponsor-side oversight of the vendor from kickoff to go-live: specification review, randomization and supply design, timelines that hold, and the change control that keeps a study build from drifting. You keep control of the decisions; we keep the vendor honest.
UAT and validation support
Test scripts written against your protocol and your supply strategy, UAT run with your team, and the evidence organized the way your quality group and an inspector expect to find it. This is also where our AI work started: an automated UAT script generator for clinical system validation.
RTSM and supply process optimization
Resupply strategies, forecast and inventory settings, site and depot logic, and the reporting around them, tuned on a live study or before the next one is built. The largest savings usually sit in the configuration nobody has revisited since first patient in.
Vendor oversight and governance
Oversight charters, governance meetings that produce decisions, metrics that predict trouble before a site runs short, and the documentation ICH E6 expects a sponsor to hold. Built for small teams that cannot staff a full vendor management function.
Fractional eClinical expertise
A senior IRT and clinical supply systems person on a retainer, for the biotech that needs the judgment a few days a month rather than a hire. The same person answers the phone every time.
Work behind the offers
Each engagement is described by the type of company; we can say more on a call.
Systems assessment and migration roadmap for a large pharma supply function
A multi-phase engagement with the clinical drug supply and logistics function of a top-10 pharmaceutical company: about sixty structured interviews, peer benchmarking, process mapping, a business capability map of the application landscape, a boundary-systems assessment ahead of an ERP migration, and a systems roadmap that includes a clinical supply control tower.
UAT script authoring for a mid-size pharmaceutical company
Test scripts written against the protocol and the supply strategy for an IRT study build, run with the sponsor team and organized as validation evidence.
AI readiness assessment for a Boston-area biotech
Where the clinical supply and operations systems stood, what AI could take on first, and what had to be in place before it did.
Category search for a top-3 pharmaceutical company
A comprehensive search and recommendation across clinical packaging, labeling, and distribution and across IRT/RTSM services, delivered in the first quarter of 2024.
Vendor implementation oversight for a Bay Area biotech
Operational and technical oversight of a new IRT vendor implementation, reducing long-term risk and putting data governance in place before the study depended on it.
Clinical supply chain reorganization at a top-10 pharma
Support and expertise for the reorganization of a global clinical supply chain function, including where AI fits into it and how it integrates with the systems already in place.
Twelve years on the vendor side
Project delivery and R&D at Cenduit, Senior Vice President of Strategic Solutions at YPrime through six years of growth from Series A to private equity, Chief Commercial Officer at Endpoint Clinical. Nine Informa IRT presentations and four years as conference chair.
Questions sponsors ask first
Are you independent of the IRT vendors?
Yes. BC Consulting has no reseller, referral, or commission arrangement with any IRT, RTSM, or clinical supply vendor. Bryan worked at three of them, which is where the judgment comes from, and that history is disclosed in any selection we run so you can weigh it. Recommendations are scored against your requirements, and you see the scoring.
Do you cover eCOA, eConsent, or EDC?
We have delivered and supported eCOA and EDC systems, and we bring that experience to the integration points where those systems meet randomization and supply. Our focus, and where we take on full engagements, is the clinical supply chain: IRT and RTSM, forecasting, depot and site inventory, labeling and distribution. For a project that is mainly eCOA or EDC, we will say so and point you to the right people.
How is an engagement shaped and priced?
Vendor selection and optimization work is fixed scope and fixed price, quoted after a 30-minute call. Implementation oversight runs for the length of the build on a monthly retainer sized to the study. Fractional expertise is a monthly retainer for a set number of days. Every engagement has a written deliverable and an end date.
Where does the AI work fit?
On top of this. The UAT script generator, the supply scenario tools, and the RFI agents on the AI service page exist because we knew the systems first. A sponsor that wants both gets one team.
Start with a conversation
Tell us the study, the system, and the decision in front of you. Thirty minutes is enough to say whether we can help and what it would cost.
Writing on IRT and RTSM
What Anthropic's $400M Biotech Acquisition Means for Your eClinical Stack
Anthropic paid $400M for a biotech team working inside regulatory workflows. What that acquisition signals about the future of the eClinical stack and the questions clinical operations leaders should be asking their vendors now.
4 min read
RTSM Optimization Starts Before the System Build
Most RTSM problems start before configuration begins. Stronger requirements, clear ownership, and disciplined execution reduce study startup risk and UAT drag.
3 min read
SCOPE 2026 - THE FUTURE OF RTSM OPTIMIZATION
At SCOPE 2026, Paul Hughes argued that RTSM has matured past risk avoidance and is ready to be optimized. His prescription starts with defining what your RTSM system is for, refusing to build without requirements, and treating RTSM data as its own asset before automating anything.
5 min read