01 vision
Bringing a therapy to patients is a chain of custody over evidence. A protocol defines what will be measured, a site generates the measurement, a monitor verifies it against source, and a regulator decides whether the chain holds. Every link is a place where something can quietly go wrong.
Most of the cost and most of the risk sit in the handoffs. A deviation caught at the source costs minutes; caught at inspection, it costs a study. The work I care about is moving verification earlier and making it continuous — risk-based monitoring that actually follows the risk, source review that is proportionate to what the data can support, and systems that surface the anomaly before a human has to go looking for it.
The computational side is not a separate career. It is the same problem approached from the other end: if the evidence is structured, traceable, and queryable, then the monitor, the medical writer, and the regulator are all reading the same truth instead of three reconstructions of it.
02 zentrial
ZenTrial is my clinical research consultancy. The premise is simple: monitoring is not a checkbox, it is the mechanism by which a sponsor keeps sight of its own study. Collaborate to Quality is the operating principle — the site, the monitor, and the sponsor working from the same understanding of the protocol rather than three interpretations of it.
ZenTrial is decentralized in Montreal and covers Quebec, Ontario, the Maritimes, and Alberta, with a network that extends to the US East Coast and Europe. Monitoring is delivered in French and English, which matters in a province where the source documents, the site staff, and the patient-facing material are not always in the same language.
Service lines
- Clinical monitoring — qualification, initiation, interim, close-out
- Site management and activation
- Qualification and feasibility
- Monitoring report authoring and review
- Essential document collection
- Remote monitoring, eSource and eReg
- Audit readiness and site support
- Interim analysis and database freeze support
- Medical writing and monitoring plans
- Subject enrolment support
- French to and from English translation
- Gene therapy and nucleic-acid therapeutics
Why Canadian regulation is its own problem
Health Canada does not read like the FDA or the EMA. Division 5, clinical trial applications, and investigational testing authorizations have their own logic, and a monitoring plan imported from a US template will miss it. That gap — between a global protocol and a Canadian site — is where most of the consulting value sits.
03 expertise
Clinical operations
- Clinical monitoring across all visit types — qualification, initiation, interim, close-out
- Risk-based and centralized monitoring; blinded and unblinded roles
- Site and study management, activation, and startup
- Co-monitoring, mentoring, and report review
- Contract research organization and sponsor-side delivery
Regulatory and compliance
- Good Clinical Practice and inspection readiness
- Health Canada clinical trial applications and investigational testing
- Medical device clinical evaluation and post-market obligations
- Electronic records and electronic signatures
- Privacy and health information handling across jurisdictions
Laboratory and translational science
- Bioanalytical method development and validation under GLP
- Ligand binding assays for biopharmaceuticals and biomarkers
- Oligonucleotide and ligation-based assay design
- RNA biology background from graduate research
- Analyst supervision and laboratory quality systems
Medical writing
- Clinical study reports and clinical evaluation reports
- Blinding plans, consent forms, and laboratory processing manuals
- Protocols, methods, procedures, and standard operating procedures
- Patient-facing material, including French translation
04 regulatory frameworks
- GCP
- ICH E6(R3) · ISO 14155:2020 for medical devices
- Canada
- Health Canada Division 5 · Clinical Trial Application (CTA) · Investigational Testing Authorization (ITA)
- United States
- 21 CFR 312 (IND) · 812 (IDE) · 50 (informed consent) · 56 (IRB) · 54 (financial disclosure)
- Records
- 21 CFR 11 (electronic records and signatures) · 21 CFR 58 (GLP)
- Privacy
- HIPAA · PIPEDA
05 therapeutic and device breadth
Studies monitored across oncology, cardiology, vaccines, gene therapy, rare disease, and orthopaedic and cardiovascular devices — from first-in-human through pivotal and post-market.
| Indication | Intervention | Phase |
|---|---|---|
| Head and neck cancer, radiation-induced xerostomia | AAV2 gene therapy | 2 pivotal |
| Endometrial and ovarian cancer | Chemotherapy ± immunotherapy | 3 |
| Acute lymphoblastic leukemia | Small molecule, comparative | 3 |
| Solid tumours | Small molecule | 3 |
| Breast cancer | Pharmaceutical | 3 |
| ATTR amyloidosis, heart failure | Small molecule | 3 |
| Treatment-resistant hypertension | Small molecule prodrug | 3b |
| Pulmonary arterial hypertension | Small molecule | 2b |
| Heart failure with chronic kidney disease | Small molecule | 2b |
| COVID-19 and influenza combination | mRNA vaccine | 2 |
| COVID-19 | DNA-based vaccine | 1 / 2 |
| Cancer pain | Cannabinoids | 2 |
| Smoking cessation | Small molecule | 3 |
| Knee osteoarthritis pain | Topical small molecule | 3 |
| Achondroplasia | Peptide hormone analog | Observational → 1 |
| Atrial fibrillation and stroke | Left atrial appendage closure | Pivotal · post-market |
| Aortic valve stenosis | Transcatheter valve | Pivotal |
| Mitral valve stenosis | Mitral valve device | Pivotal |
| Coronary artery disease | Drug-coated balloon and stent | Pivotal |
| Peripheral and coronary arterial disease | Intravascular catheter | First-in-human |
| Knee and hip osteoarthritis | Computer-assisted arthroplasty | Post-market |
06 clinical systems
Working fluency across the platform stack a study actually runs on — not just the modules, but the handoffs between them.
- EDC
- Medidata Rave · Oracle · OmniComm · Zelta (IBM eClinical) · Medrio · Merge · TrialMaster
- CTMS
- Medidata CTMS · Veeva CTMS · Oracle Siebel Clinical · Impact Express · Clindex
- eTMF
- Veeva · PhlexView · Florence · SureClinical · Clindex
- ePRO / eCOA
- DSG eCaseLink · Clario
- IRT / IWRS
- Cytel Zelta · Almac · Endpoint · Calyx
- Central lab
- LabCorp · LabConnect · Cirion · PPD · Stemcell
- Imaging and EMR
- EPIC · OACIS · Vestigo
- Remote and eSource
- CRIO · RealTime · eFlorence · Advarra · secure file transfer
- IRB / REB
- WCG · Advarra · Veritas · WIRB · Quebec REBs · Ontario CTO
- IP and supplies
- Thermo Fisher · Ancillare · sponsor-specific systems
- Training
- Longboat · sponsor and CRO custom platforms
07 computational practice
The technical side, built and run on hardware I control. Local models, local vector stores, no third-party inference — partly cost, partly a conviction that unpublished data should not leave the machine it was generated on.
- languages
- Python · C++ · Bash · JavaScript · SQL
- retrieval
- FAISS · BM25 hybrid search · sentence embeddings · citation-bearing answers
- models
- llama.cpp · local inference · PyTorch · evaluation harnesses
- pipelines
- document extraction · structure-preserving chunking · reproducible runs
- infrastructure
- Linux · CUDA · Apache · Postgres · Redis · systemd
- science
- bioanalytical assay design · RNA biology · sequence and structure analysis
- bookkeeping
- Ledgeryt — double-entry accounting, which is what the consultancy actually runs on
A note on that last line: I use Ledgeryt to keep ZenTrial's books. It is a real double-entry system underneath — not a spreadsheet with a login — and it has held up across a full year of filings. I mention it because a tool you rely on for your own books is a better endorsement than one you merely recommend.
08 scientific contributions
Seven peer-reviewed papers across fifteen years, tracing a line from RNA biology through oligonucleotide bioanalysis to the regulatory thinking that shaped how those assays get validated.
Oligonucleotide bioanalysis
- Tremblay, G.A. 2017. A narrative for bioanalytical method development. Editorial. Bioanalysis. 9 (3): 233–234. DOI 10.4155/bio-2016-0287
- Tremblay, G.A., Khalafaghian, G., Legault, J., Nielsen, P. and Bartlett, A.J. 2011. Specific determination of oligonucleotide therapeutics with the dual ligation hybridization assay. Bioanalysis. 3 (5): 499–508.
- Tremblay, G.A., Oldfield, P.R. 2009. Bioanalysis of siRNA and oligonucleotide therapeutics in biological fluids and tissues. Review. Bioanalysis. 1 (3): 595–609.
RNA biology and RNA-binding proteins
- Tremblay, G.A., Richard, S. 2006. mRNAs Associated with the Sam68 RNA Binding Protein. RNA Biology. 3 (2): 90–93.
- Richard, S., Torabi, N., Valverde-Franco, G., Tremblay, G.A., Chen, T., Vogel, G., Morel, M., Cleroux, P., Komarova, S., Tremblay, M.L., Li, W., Gao, Y.J. and Henderson, J. 2005. Ablation of the Sam68 RNA binding protein protects mice from age-related bone loss. PLoS Genetics. 1 (6): 676–688.
- Brukner, I., Tremblay, G.A. 2000. Cellular proteins prevent antisense phosphorothioate oligonucleotide (SdT18) to target sense RNA (rA18): development of a new in vitro assay. Biochemistry. 39 (37): 11463–6.
Epidemiology
- Tremblay, G.A. 2007. Historical statistics support a hypothesis linking tuberculosis and air pollution caused by coal. International Journal of Tuberculosis and Lung Disease. 11 (7): 722–732.
Patents
- 2026 WO2026000074 — Use of CD38 inhibitors for reducing Th2 inflammation.
- 2010 Guy A. Tremblay. April 2010 and November 2009. Dual ligation methods for detecting oligonucleotides. USPTO US 61/327,245 and US 61/258,046.
- 2008 Guy Tremblay. June 2008. Tuberculosis screen, treatment and vaccine thereof. US 60/944,226.
- 2000 Ivan Brukner, Guy Tremblay, Bruno Paquin. January 2000. Process for the generation of oligonucleotide libraries (OLs) representative of genomes or expressed mRNAs (cDNA) and uses thereof. WO 00/43538.
09 education and affiliations
- MBA
- Université du Québec à Montréal — MBA for Managers
- MSc
- Université de Montréal — Biochemistry, RNA biology
- BSc
- Université du Québec à Montréal — Biochemistry
- training
- Oncology trial monitoring (UC San Diego) · GCP · HIPAA · GLP · 21 CFR 11 · hazardous substances and radioisotopes
- memberships
- ACRP · AAPS · ASGCT
- languages
- French (native) · English (fluent) · Spanish (spoken)
10 side
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