Your Evidence Will Face Microscope-Level Scrutiny.
We Stress-Test It First. Audit-Ready Analysis in 4 Weeks.Incomplete evidence = failed committee review. One gap in your submission = decision delayed or denied. We deliver the objective analysis that survives scrutiny from regulatory committees, infection control boards, BD teams, and institutional review.
Pharma & Medical Devices
Your $50M licensing deal depends on defensible science. One gap in your dossier = deal failure. We deliver evidence that survives hostile due diligence.
Hospital Groups & Health Systems
Infection control committees need objective evidence. Quality reporting requires data-driven protocols. We deliver standard-of-care analysis for formulary decisions, protocol updates, and CMS reporting.
Clinical Trial Support
Your $100M Phase 3 trial needs rock-solid protocol design. Weak endpoint justification = regulatory delay. We deliver the literature review that justifies your design.
Regulatory Submissions
FDA Advisory Committee will interrogate your evidence. Incomplete literature search = dossier rejection. We deliver the stress-tested evidence that survives microscope-level review.
Deliverables That Survive Scrutiny
Regulatory-grade evidence. Not consulting fluff.
Objective, Defensible Meta-Analysis
Pooled effects, heterogeneity assessed, publication bias checked. Survives scrutiny from regulatory committees, infection control boards, and BD teams.
Gap Identification + Correction
We find weaknesses, ambiguities, and over-claims before review committees do. Not just identification—we provide concrete corrections that strengthen your submission.
Audit-Ready Documentation
240M+ articles searched. 100% of relevant studies included. Methodology defensible under committee scrutiny. Zero gaps.
4-Week Turnaround
Standard meta-analysis delivered in 4 weeks. Expedited options available for urgent committee deadlines or time-sensitive decisions.
The Cost of Incomplete Evidence
FDA Advisory Committee Rejection
$2M+ regulatory delay. Market entry blocked 18+ months.
Infection Control Committee Protocol Rejection
Incomplete evidence = protocol update denied. HAI rates remain elevated. CMS quality penalties continue.
Pharma BD Finds Gaps During Diligence
$50M licensing deal falls through. Asset valuation collapses.
Payer Denies Reimbursement
Incomplete meta-analysis = market access denied. Revenue projections cut 60%.
We deliver evidence that survives the microscope-level review your asset will face.
Scoped Engagements. Fixed Timelines.
We scope each engagement to your regulatory timeline and evidence requirements.
Evidence Summary
PRISMA-compliant systematic review with quality grading and gap identification
Full Meta-Analysis
Pooled effects, heterogeneity assessment, gap analysis with concrete corrections
Regulatory Dossier
FDA Advisory Committee-ready, HTA submission-grade, microscope-level review
Each engagement includes PRISMA-compliant methodology, gap identification with concrete corrections, and follow-up consultation. Premium retainers available for multi-asset portfolios and ongoing evidence needs.
Don't Risk Your Decision on Incomplete Evidence
One gap = committee rejection. One missed study = decision delayed. We deliver the objective, stress-tested evidence your institution deserves. 4-week turnaround. Audit-ready documentation. Zero surprises.