Independent feasibility risk review for biotech sponsors

Don't Buy Feasibility Blind.See the risk before it gets expensive.

Miterion helps biotech sponsors challenge CRO feasibility assumptions, country selection risks and visible recruitment competition before they become budget commitments.

48–72h review · public registry signals · manual validation · clear data limits

Use Miterion before feasibility assumptions become commitments.

Your CRO proposal looks too optimistic

Check timeline, country mix, site assumptions and visible recruitment pressure before bid defense or signature.

You are narrowing countries before RFP

See where public registry signals support the shortlist — and where they raise questions.

Your team needs a board-ready second opinion

Turn fragmented public signals into a clear decision memo for internal discussion.

You do not have a large internal team

Get a focused external challenge without adopting a full enterprise feasibility platform.

Engagement Options

Choose the right starting point

Start with a free public registry signal, or request an analyst-led review when the decision carries budget risk.

CRO Proposal Comparison Review

Independent comparison and risk review of CRO feasibility assumptions before bid defense, scope lock or signature.

For biotech sponsors comparing multiple CRO proposals, preparing for bid defense or validating country/site assumptions before commitment.

Scope & Analysis:

  • ✓ Cross-vendor country mix & proposed timeline comparison
  • ✓ Site count assumption review & visible recruitment competition
  • ✓ Scope gaps, optimistic assumptions & benchmarking between proposals

Output:

Proposal risk summary, assumption gap list, vendor comparison matrix, bid defense questions, and recommended next steps and validation questions.

From €3,500 for up to 3 proposals
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Pre-Feasibility Decision Memo

Public-signal review before formal feasibility, country selection or RFP.

For sponsors who need to understand visible trial activity, recruitment competition and country-level risk before spending on formal feasibility.

Analysis Scope:

  • ✓ Public registry signal summary
  • ✓ Recruitment competition overview & country-level risk table
  • ✓ Visible sponsor/trial activity & data limitation notes

Output:

Decision memo tailored to deliver clean, decision-oriented recommendations to show what should be trusted, challenged or narrowed before commitment.

From €2,500

Free Trial Landscape Snapshot

A first-pass view of visible public registry activity. Not a feasibility decision.

Generate a quick snapshot of visible public trial activity for an indication, geography or development question.

Need to challenge a CRO proposal or country shortlist? Request an analyst-led review.

Deliverables

What you get

A focused review designed to show what should be trusted, challenged or narrowed before feasibility assumptions become commitments.

Executive Risk Summary

A one-page view of the main feasibility risks, visible pressure points and recommended next step.

Country-Level Risk Table

A structured view of country-level trial activity, visible recruitment pressure and public-data support.

Assumption Gaps

Weak, unsupported or overly optimistic assumptions found in a CRO proposal, country shortlist or planning narrative.

Sponsor Footprint

An analysis of active sponsors currently operating trials in your target countries to gauge resource and investigator competition.

CRO Questions

Practical questions to send back before bid defense, scope lock or signature.

Data Confidence

A clear distinction between what public data supports, what it only suggests and what it cannot confirm.

See the structure before you request a review

Review a sample memo structure showing how Miterion separates public signals, assumption gaps, CRO questions and decision recommendations.

Sample memo coming next

Framework

How we review feasibility assumptions

Miterion does not replace formal feasibility. It checks whether visible public signals support, challenge or fail to confirm the assumptions behind a planned decision.

01 / Analysis

Public Signal Review

We check visible registry activity, competing trials, sponsor presence, recruitment status and country-level trial density.

02 / Evaluation

Assumption Challenge

We compare public signals against the proposed country mix, timeline, site assumptions and vendor narrative.

03 / Output

Decision Framing

We translate findings into practical questions, risks and next steps before RFP, bid defense, formal feasibility or CRO commitment.

Decision confidence levels

Each finding should be framed by confidence level, so sponsors know what can be used for early decision support and what requires formal feasibility or vendor clarification.

A — Supported

Public signals are consistent and directionally useful for early decision support.

B — Challenge

Public signals raise questions, show contradiction or suggest the assumption needs vendor clarification.

C — Cannot Confirm

Public data is insufficient. Formal feasibility, site outreach or CRO clarification is required.

Data Boundaries

What public data can and cannot support

Public registry data is useful for early risk detection, but it does not replace formal site feasibility.

Public data can help detect

  • Visible recruitment competition
  • Crowded indications
  • Country-level trial activity
  • Sponsor presence
  • Registry inconsistencies
  • Weak assumptions in proposal narratives
  • Visible mismatch between public signals and vendor claims

×Public data cannot confirm

  • Actual site enrollment performance
  • Investigator availability
  • Contracted recruitment targets
  • Coordinator capacity
  • Contract and budget negotiation timelines
  • True site readiness
  • Real screen-failure risk
  • Operational execution quality

That is why Miterion is not a replacement for formal feasibility. It is an early independent risk review before formal feasibility spend, RFP decisions or CRO commitment.

Delivery Flow

How the review is delivered

A short, focused review process designed for decisions that cannot wait for another long feasibility cycle.

01

Send the decision context

Tell us what you need to validate: CRO proposal, country shortlist, RFP decision, indication, phase and target geography.

02

We review signals and assumptions

Miterion checks visible registry activity, recruitment competition, sponsor footprint and proposal assumptions against the decision you are about to make.

03

You receive a decision-ready memo

You get a focused review with risk signals, assumption gaps, CRO questions and recommended next steps before budget or CRO commitment.

Our Position

Why independent review matters

Independent

Miterion does not sell countries, sites or CRO services. We review assumptions before they become commitments.

Fast

Focused decision intelligence in 48–72 hours, not a long consulting process.

Clear data limits

Public registry data can reveal visible feasibility risks, but it does not replace formal site feasibility. Miterion shows what the data can and cannot support.

Sources may include ClinicalTrials.gov, EU CTIS, EU Clinical Trials Register / EudraCT records, WHO ICTRP, ISRCTN and selected national registries where relevant.

Free Tool

Generate Your Free Trial Landscape Snapshot

See visible recruitment competition signals from public registry data.

Generate Snapshot Preview

What it tells you

The snapshot shows visible activity in structured public registry data. It can help you see whether your indication and geography look crowded, thin, sponsor-heavy or worth deeper review.

What it cannot tell you

It does not show actual site enrollment performance, investigator capacity, contract timelines, coordinator availability, or operational readiness. These require formal feasibility work.

Not sure which path fits your trial?

Send a custom review request or book a short call if the decision is urgent.