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Clinical Trial Capability Map

Where is your trial machine strong, and where is it dragging?

Rate 14 clinical-trial domains on performance vs. need. End with a color-coded capability map of your operation — strengths, gaps, and the specific capabilities driving them.

Build your map
Takes about 5 minutes14 domainsDownloadable PNG + PDF

Focused on AI readiness specifically? Try the AI Maturity Assessment instead.

The Scale

How the rating works.

For each domain, ask: how well does this perform today, relative to what our trials actually need?

  1. Major gap

    Well below what the trial needs — a known source of risk, delay, or rework.

  2. Underperforming

    Works, but a known drag on cost, timelines, quality, or oversight.

  3. Adequate

    Meets the bar today — not a constraint, not a differentiator.

  4. Strong

    A competitive advantage — consistently a source of speed, quality, or trust.

The Domains

14 domains, grouped study-level and program-level.

The same map clinical operations and development leaders use to scope where execution risk lives.

Study Management

Study

Study Design · Project & Timeline Management · Study Training Management · Core Study Document Management · Risk Management (RBQM) · TMF Management · Protocol Deviation Management

Site Management

Study

Site Assessment & Selection · Site Initiation · Site Monitoring · Site Payments Oversight · Site Close-Out

Subject Management

Study

Recruitment & Diversity Strategy · Subject Enrollment · Retention & Engagement · Decentralized / Hybrid Trial Elements

Safety Management (Trial-Level)

Study

Safety Signal Tracking · Medical Monitoring · HA Safety Reporting · Site / IRB / IEC Safety Reporting · DSMB / Data Adjudication

IP & Trial Supply Management

Study

IP / Non-IP Supply Forecasting · Site Supply Management · RTSM / Randomization · Cold Chain & Logistics

Lab & Biospecimen Management

Study

Central Lab Oversight · Sample Collection & Chain of Custody · Lab Results Integration · Biomarker Sample Management

Clinical Data Management

Study

CRF & EDC Build · Patient Data Integration (ePRO/eCOA) · Data Standards (CDISC/CDASH) · Data Review & Query Resolution · Database Lock

Statistics & Programming

Study

Statistical Planning & SAP · Statistical Analysis · Programming & TLF Production · SDTM / ADaM Datasets

Medical Writing

Study

Clinical Study Report (CSR) Authoring · Investigator's Brochure (IB) · Protocol Authoring & Amendments · Regulatory Submission Narratives · Plain Language Summaries

Drug Development Strategy

Program

Indication & Target Population Selection · Endpoint Strategy & Biomarker Planning · Phase Transition & Go/No-Go Frameworks · Competitive Landscape & TPP · Development Plan (IDP/CDP)

Regulatory Strategy & Submissions

Program

IND / CTA Preparation & Maintenance · HA Meeting Strategy (Pre-IND, Type B/C, Scientific Advice) · Protocol Amendment Management · HA Query Responses · Trial Registration & Notifications · NDA / BLA / MAA Readiness

Pharmacovigilance & Aggregate Safety

Program

SUSAR Reporting & Narrative · DSUR / PBRER Preparation · Benefit-Risk Surveillance · Signal Detection

Vendor & CRO Governance

Program

Vendor Selection & Qualification · Contract & Budget Management · KPI / QTL Oversight · Change Order Management · Audit Rights Management

Quality & Compliance

Program

GCP Audit Readiness · CAPA Management · Quality Management System (QMS) · Inspection Readiness · SOP Development & Maintenance

What you get

What's in the exercise.

14 trial domains

Nine study-specific domains (study management, sites, subjects, safety, supply, lab, data, stats, medical writing) plus five program-level domains (development strategy, regulatory, PV, vendor governance, quality).

Performance vs. need

Rate each domain on how well it performs today relative to what your trials need. Operational drag, not abstract maturity.

Drill-down on the gaps

For any underperforming domain, optionally flag the specific capabilities driving the gap so the map shows you the work, not just the headline.

Downloadable artifact

Export the colored map as a PNG for slides or save the full report as PDF. Bring it into your next operations review.

In the report

What you walk away with.

  • Color-coded capability map (PNG-ready) showing every domain at a glance
  • Specific capabilities flagged inside any underperforming domain
  • Distribution across the four ratings, with overall average
  • "Where to focus first" — the two or three constraints with the biggest impact on delivery
  • Strengths to build on and recommended next moves
  • Downloadable as PNG (slides) or PDF (full report)

Ready to see your trial operation on one page?

Five minutes. A downloadable map. We follow up only if you ask us to.

Build your map