Clinical Trial Consulting Services - Strategy, Trial Planning & Conduct Readiness

Clinical Trial Consulting

Early planning is where clinical trials are won or lost. A strong concept can still fail because of unrealistic timelines, unclear endpoints, weak feasibility assumptions, or a regulatory path that doesn’t match the target markets. Pharmaxi provides paid clinical trial consulting to help you make the right decisions before you commit major budget and operational resources.

We work with sponsors across medicines, medical devices, and IVD—bringing together clinical operations, regulatory thinking, data and documentation expertise to turn your idea into a plan that can be submitted, executed, and defended.

Contact an expert

What we help you to clarify

How much will it cost? How long will it take? What’s the optimal strategy? What design gives you credible results without overbuilding the study? We translate uncertainty into a structured plan-budget, milestones, and a study design that fits both clinical reality and regulatory expectations.

Regulatory strategy for pharma and medical devices

Regulatory pathway + submission approach (what’s needed now vs later)
Indication / disease / intended use fit (what is the most relevant claim)
Evidence strategy mapped to claims (what evidence for each claim)
Protocol + endpoints aligned to intended use (primary/secondary support claims)
Risk-based approach to study management + documentation depth/controls
Data integrity + traceability (audit-ready from day one)
Site contract / legal / regulatory readiness + essential/primary documentation
Authority/ethics interaction plan (positioning, RFIs, timelines)
Change control & lifecycle plan (amendments / substantial modifications)
Go/No-go decision points to avoid late redesigns

Trial planning

Study design selection (phase/type, arms, comparator, rationale)
Intended use/claims alignment (design + endpoints support what you want to prove)
Endpoints strategy: primary/secondary/exploratory + success criteria
Safety endpoints + safety oversight concept (what/why/how monitored)
Target population + eligibility logic (scientific value + feasibility)
Country & site feasibility assumptions (startup, recruitment realism, timelines)
Operational timeline & resourcing plan (roles, vendors, responsibilities)
Data strategy: what is collected, where stored, access/retention, audit trail needs
Budget model: key cost drivers + trade-offs (scope vs speed vs quality)
Risk register + mitigation plan (operational/data/regulatory risks)

Trial conduct readiness

Site strategy & readiness (selection, startup plan, training, oversight model)
Site contracts/legal readiness + essential/primary documentation expectations
Vendor strategy & interfaces (who does what; handoffs; accountability)
Digital platforms setup plan: EDC, eTMF, randomization/IRT, eCOA/ePRO (fit-for-purpose)
Risk-based study management/monitoring approach (focus on critical data/processes)
Data integrity & traceability operations (source approach, queries, audit trail, change control)
Data flow execution: collection → cleaning → reconciliation → database lock
Statistics touchpoints (analysis plan, interim/final outputs, reporting timeline)
Authority/ethics communication readiness during conduct (RFIs, timelines, responses)
Lifecycle execution plan: amendments/substantial modifications, notifications, reporting obligations

Clinical Trial Consulting

What we help you to clarify

Regulatory strategy for pharma and medical devices

Trial planning

Trial conduct readiness

Built on Pharmaxi’s delivery capabilities

Free Consultation