Clinical trial strategy · Operations · AI-assisted intelligence

Turn your clinical strategy into an executable trial.

TrialCraft helps emerging biotech sponsors and funded investigator-led study teams move from protocol decisions to operational delivery, from feasibility and Canadian activation to randomization, study systems and first patient in. Senior clinical operations expertise, bilingual execution and AI-assisted intelligence, without the overhead of a large consultancy.

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Protocol to execution Health Canada & ICH-GCP AI-assisted, expert-reviewed Bilingual EN / FR

Mission

Better clinical decisions, carried through to execution.

TrialCraft gives emerging biotech teams direct access to experienced clinical trial planning, operational execution and structured AI-assisted intelligence. Our mission is to reduce avoidable risk between protocol concept and first patient in.

Strategy is useful only when it can be executed. Every recommendation is tested against regulatory requirements, site realities, timelines, systems and budget.

AI accelerates evidence review, precedent mapping and structured risk analysis. Senior human judgment remains accountable for every conclusion, recommendation and client deliverable.

Services

Strategy, systems and execution

Focused engagements for emerging biotech sponsors, funded investigator-led study teams and CROs that need clearer decisions, reliable study systems and senior operational ownership.

Strategy

Protocol & Operational Strategy

Structured protocol review focused on operational feasibility, endpoint implementation, eligibility burden, site realities, Canadian requirements and practical risks that may affect startup or execution. Where specialist medical, statistical or therapeutic-area input is required, it can be identified and scoped as part of the engagement.

AI-assisted Intelligence

AI-Assisted Clinical Intelligence

Expert-reviewed protocol intelligence, literature synthesis, competitive landscape review, regulatory precedent mapping and structured risk identification. AI accelerates evidence gathering and structured analysis; TrialCraft applies expert judgment and remains accountable for the final recommendation.

Activation

Canada & Quebec Trial Activation

Feasibility through first patient in for Phase 2 to 4 trials. Health Canada submissions, REB and CÉR coordination, French-language requirements, Quebec Law 25, site contracts, budgets and startup management.

Specialty

Controlled-Substance Trial Readiness

Secure storage, chain of custody, accountability, dispensing SOPs, pharmacy readiness and navigation of applicable licences or exemptions for scheduled products.

Study systems

REDCap, Randomization & Study Systems

Protocol-to-eCRF REDCap builds, validation, edit checks, audit-ready documentation, DSMB-ready exports and concealed block, stratified or minimization randomization for biotech-sponsored and funded investigator-led studies.

Embedded leadership

Fractional Clinical Operations

Senior clinical operations leadership for early-stage biotech teams needing activation, vendor oversight, budget and timeline management, risk coordination and execution without a full-time hire.

Flagship engagement

Protocol & Operational Risk Review

A fixed-scope, expert-reviewed assessment that identifies the protocol and execution risks most likely to affect startup, site delivery and Canadian readiness.

Operational-feasibility and eligibility-burden review
Endpoint-implementation and site-readiness assessment
Canadian and Quebec requirement mapping
Prioritized risk register, recommendations and next steps

Request a protocol review

Also available · DSMB setup · vendor selection · site budget and contract negotiation · Quebec market entry · strategic advisory

Who we support

The right level of support for the team carrying the study.

TrialCraft is most useful when a real study is funded or approaching execution, but the internal team does not have all of the operational infrastructure or specialized capacity it needs.

Biotech sponsors

Emerging biotech sponsors

For CMOs, clinical-development leaders and clinical-operations teams preparing a protocol, Canadian strategy, startup plan or operational-risk decision.

Investigator-led studies

Funded investigator-led study teams

For principal investigators, sponsor-investigators and research teams that need randomization, REDCap, DSMB-ready outputs, startup workflows or multicentre study infrastructure.

Investigator-Initiated Trial Systems

Practical support that translates the protocol and statistical plan into an auditable randomization, database and operating workflow the study team can use.

Discuss your investigator-led study

CRO partners

Small and midsize CROs

For clinical-operations and project leaders who need bilingual Canadian or Quebec capacity, study systems or defined specialist implementation support.

TrialCraft Intelligence

Faster analysis. Traceable evidence. Human accountability.

TrialCraft uses structured AI-assisted workflows to accelerate the research-heavy parts of clinical strategy while keeping expert review, source traceability and client context at the centre of every conclusion.

Step 01

Frame the decision

Define the protocol question, business context, evidence standard and decision the analysis must support.

Step 02

Synthesize the evidence

Review protocols, guidance, publications, trial precedents and competitive information through a structured workflow.

Step 03

Apply expert judgment

Challenge the output, identify missing context, rank risks and distinguish evidence from inference.

Step 04

Deliver an action plan

Provide prioritized recommendations, supporting sources, open questions and clear next steps.

AI-assisted work is never delivered without expert review. Confidential client information is handled according to the confidentiality and data-processing requirements agreed for the engagement.

From Canadian feasibility to first patient in.

One accountable point of coordination across strategy, regulatory, ethics, contracts, systems and site activation.

01Feasibility & strategy

02Health Canada CTA

03REB / CÉR & Quebec requirements

04Contracts, systems & readiness

05Site activation & first patient in

Engagement model

Start focused. Build only what the program needs.

Step 01

Assess

Begin with a focused consultation or fixed-fee diagnostic that clarifies the decision, risks, scope and recommended path.

Step 02

Build

Implement the agreed deliverable: protocol intelligence, activation planning, study systems, readiness work or a complete startup package.

Step 03

Operate

Continue with fractional leadership or defined operational support when the program needs ongoing ownership.

Founder-led

Ahmad Fakhoury

TrialCraft is led by Ahmad Fakhoury, a clinical trial manager with approximately ten years of clinical research experience. At the Douglas Research Centre, McGill's affiliated mental health institute, he leads site activation for a Phase 3 sponsor trial and manages a multi-site clinical program.

Ahmad holds an M.A. in Biotechnology from Columbia University, works in English and French, and built controlled-substance research readiness from the ground up. He founded TrialCraft to give emerging biotech sponsors direct access to senior, hands-on clinical operations and structured clinical intelligence without the layers of a large consultancy.

Clients work directly with the person responsible for the analysis, recommendations and execution.

M.A. Biotechnology, Columbia ~10 years in clinical research Phase 3 CNS experience Bilingual EN / FR

Start with the decision

Have a protocol, a Canadian launch or an operating gap?

Tell TrialCraft where the program stands and what decision or deliverable is holding it back. The first conversation will identify the smallest, clearest engagement that can move it forward.

Book a consultation Submit a project brief

Do not submit personal information, health information, participant-identifying information or confidential documents through the public intake form. Secure document transfer can be arranged separately.

consult@trialcraft.co 514 430 5748 LinkedIn Montreal, QC