What does Guy Tremblay do?

Guy Tremblay is a clinical research professional and the founder of ZenTrial, a consultancy providing clinical monitoring and site management services across Canada in French and English. He has twenty years of biomedical research experience across pharmaceuticals and medical devices.

Where does ZenTrial provide clinical monitoring?

ZenTrial is decentralized in Montreal and covers Quebec, Ontario, the Maritimes, and Alberta, with a network extending to the US East Coast and Europe. Monitoring is delivered in French and English.

What regulatory frameworks does Guy Tremblay work with?

ICH GCP E6(R3) and ISO 14155:2020 for medical devices, Health Canada Division 5 including Clinical Trial Applications and Investigational Testing Authorizations, 21 CFR Parts 312, 812, 50, 56, 54, 11, and 58, plus HIPAA and PIPEDA.

What therapeutic areas has Guy Tremblay monitored?

Oncology, cardiology, vaccines, gene therapy, rare disease, and orthopaedic and cardiovascular medical devices, from first-in-human through pivotal and post-market studies.

Guy Tremblay, MBA MSc

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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.

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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.

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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

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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

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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.

Representative indications and phases
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

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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

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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.

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08 publications and patents

Peer-reviewed research from graduate work in RNA biology, alongside patent filings. Full citations and patent numbers are available on request.

Peer-reviewed publications in RNA biology and biochemistry
Patent filings in the life sciences

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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)

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10 side

The Kindness Machine — a small, free, ad-free page that gives you one genuine reason to smile. No sign-up, no tracking, no network calls.