Clinical Research Sales & Operations Workflow Audit
An outside eye on your
sales & operations workflow.
A review of how your team runs the full lifecycle, from prospecting and feasibility through contracting, activation and study startup to First Patient In. Where is each stage tracked? Who owns each handoff? Where do studies stall? The audit answers all three.
- Seven stages, prospecting to First Patient In
- Report 48–72 hours after your intake
- No system access required
- Works with any CRM, CTMS or spreadsheets
What you receive
Ten deliverables, built from
your answers.
Nothing is a generic template. Every recommendation maps to the seven stages of your own workflow.
Seven-Stage Intake Questionnaire
Structured questions mapped to each stage, from prospecting through enrollment visibility. About 30 minutes. No system access required.
Current-State Workflow Review
How each stage runs today: where it is tracked (CRM, CTMS, spreadsheet, email or nowhere), who owns each handoff, what is automated and what leadership can see.
Stage-by-Stage Gap Analysis
Gaps at each of the seven stages, ranked by operational impact.
Data Model & Tracking Recommendations
How to track studies, site profiles, study-site status, activation, vendor services, the physician and site pipeline and enrollment reporting, in whatever system you use.
Automation Opportunity Map
Where status-based triggers and notifications remove the most manual steps, prioritized by time saved and go-live impact.
Revenue & ACV Review
Your ACV logic, per-patient fee tracking, site count modeling and enrollment projections, with recommendations for a defensible revenue model.
AI-Readiness Score Per Stage
A 0–100 score per stage for data structure, naming standards and readiness for site matching, enrollment forecasting and IRB timeline prediction.
30-Day Prioritized Roadmap
Tasks, owners and sequencing tied to your most urgent go-live pressure. Your team can start the day after the review call.
Audit Scorecard
Workflow Structure, Operational Efficiency and AI-Readiness, scored. Shareable with your COO or VP to make the case for the fix.
60-Minute Executive Review Call
Optional. A walk through every finding and the roadmap, and agreement on what to fix first.
Inside the report
Your gaps, scored.
Every audit scores three dimensions from your intake answers. It's the page you hand your COO or VP of Operations.
Workflow Structure
38 / 100
- Each study tracked as its own record
- Feasibility tracked in the system of record
- Site profiles exist
- Study-site status tracked per site
- Regulatory packet tracked per site
Operational Efficiency
42 / 100
- Automatic handoff from won deal to study startup
- IRB deadline automation
- Some milestone tracking in place
- Greenlight % calculated automatically
AI-Readiness
29 / 100
- Standardized Study and Site ID naming
- Historical site enrollment data structured
- Screen-failure reason codes standardized
Illustrative sample. Your scores come from your own intake answers.
How it works
About a week, start to finish.
-
01Day 0
Order and pay
Pay by card, bank transfer or invoice. The intake link arrives as soon as payment clears.
-
02Day 0–1
Complete the intake
About 30 minutes, at your own pace. No system access and no call needed.
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03Day 2–4
Receive the report
Gap analysis, scorecard, data model recommendations, AI-readiness per stage and the 30-day roadmap, 48 to 72 hours after your intake.
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04Day 5–7
Optional review call
60 minutes on every finding and what to fix first. The report stands on its own if you skip it.
The intake
26 questions across
all seven stages.
Each question surfaces a specific gap or confirms a capability. It's what makes 48–72 hour delivery possible.
See all 26 questions
01
Prospecting
Early opportunities · sponsor/CRO targeting
- 1.1Opportunity Tracking. Before an RFP arrives, how are prospective sponsors, CROs, and studies tracked? A structured pipeline in your CRM, a basic list, or spreadsheets and email?
- 1.2Fit Intelligence. Do you keep account or therapeutic-fit information anywhere that helps decide which studies are worth bidding on? Prior relationships, TA strengths, historical win rates?
02
Opportunity / RFP Intake
Intake · RFP and CDA
- 2.1RFP / Protocol Intake. How are new study RFPs or protocol synopses logged today? Typed into your CRM by hand, forwarded around by email, pulled in from another system, or not logged at all?
- 2.2CDA Tracking. How is CDA exchange tracked? Is there a dedicated field or record for it, or is it buried in email and opportunity notes?
03
Feasibility
Feasibility · assessment and go/no-go
- 3.1Feasibility Survey. Is the feasibility survey managed in your CRM or CTMS? If not, where does it live today (email, Excel, an external tool)?
- 3.2Complexity Scoring. Does each opportunity carry a complexity score that factors in protocol difficulty, site count, therapeutic area, and enrollment targets?
- 3.3ACV Calculation. How is ACV or study revenue calculated today? Worked out automatically in your system, typed in by hand, or kept in a spreadsheet off to the side?
04
Proposal, Budget & Contracting
Contracting · CTA and commitments
- 4.1CTA Tracking. How is the Clinical Trial Agreement tracked — negotiation status, execution date, budget version, and amendment history? And where: your CRM or CTMS, a separate contract tool, or email?
- 4.2Budget & Work Order. Are budget, Work Order, or MSA execution tracked as startup-critical milestones in your system of record, or do they live somewhere else?
- 4.3Enrollment Commitment. Is the enrollment commitment made during the sale captured and carried into operations — or does it stay in the proposal and get re-discovered later?
05
Site / Service Activation Planning
Activation planning · selection and readiness
- 5.1Site / Service Profile. Do you keep a structured profile for each site that tracks infrastructure, therapeutic-area experience, staff capacity, and historical performance?
- 5.2SSV Tracking. How is the Site Selection Visit (SSV) tracked — date, type, outcome, and follow-up? Is it in your CRM or CTMS, or in notes and email?
- 5.3PI Management. How are Principal Investigators tracked — availability confirmation, CV status, GCP certification date, and therapeutic-area experience?
- 5.4Study-Site Relationship. Is there a record connecting each study to its selected sites, with individual status, scoring, and milestone tracking per site per study?
- 5.5Qualification Scorecard. Is there a composite qualification score per site — or is site selection a judgment call with no structured scoring written down anywhere?
06
Study Startup
Startup · regulatory through greenlight
- 6.1Regulatory Packet. Is there a regulatory packet checklist that tracks Form 1572, CV, financial disclosure, and required document status per site — with flags for missing items?
- 6.2IRB / IEC Submission. How is IRB/IEC submission and approval tracked — submission date, approval date, expiry, and amendment history — or is this managed in email and an external system?
- 6.3SIV Milestone. Is the Site Initiation Visit tracked as a milestone in your system, with scheduled date, completed date, and training attestation? Or is it just recorded in notes?
- 6.4Greenlight Tracking. Is Site Greenlight Percentage — activated sites ÷ total selected — calculated automatically and visible on a real-time dashboard? Or delivered via manual status report?
- 6.5Spreadsheet Count. How many external spreadsheets does your startup team currently use to track processes that should live in your system of record? Name the top three if possible.
07
First Patient In / Enrollment Visibility
Launch · visibility layer only, no PHI
- 7.1Recruitment & Pre-Screening. Are recruitment campaigns and pre-screening tracked in your CRM or CTMS (channel, leads, pass/fail scores, and screen-failure reason codes), or does this happen in other tools?
- 7.2Screen Failure Logging. Is the screen-failure log kept in your CRM or CTMS with reason codes and aggregate fail rates per site — or is it in the EDC or a spreadsheet?
- 7.3Enrollment Dashboard. Can leadership see enrollment velocity, enrolled vs. target per site, and forecast vs. actual against the protocol timeline — without subject-level clinical data?
- 7.4Enrollment Alerts. Are there automated alerts when a site hits an enrollment milestone or when screen-failure rate exceeds an acceptable threshold?
- 7.5Data Quality. On a scale of 1–10, how much do you trust the enrollment and site-performance data in your systems for executive reporting — and the biggest reason for that score?
- 7.6FPI Definition. How does your organization define First Patient In — first consented, screened, enrolled, randomized, or dosed?
Questions
Do you need access to our CRM or other systems?
No. The intake captures everything the analysis needs. Read-only access is welcome if it's easy, but the audit is complete without it.
What if we're still building and not fully live?
Then it's worth more, not less. The gap analysis tells you what to set up right before workarounds and one-off spreadsheets pile up.
Only some of our stages are tracked in a system. Is that okay?
Yes, and it's the most common situation. It works with whatever you run: Salesforce, another CRM, a CTMS or spreadsheets. The audit shows which stages are covered, which aren't, and the order to fix them in.
Who reads our answers and writes the report?
Your report is produced from your intake answers and reviewed by John before it's sent to you. Nothing goes to you unreviewed.
What happens after the audit?
Most teams hand the roadmap to their own admin or vendor. If you want ongoing advisory and start within 14 days of delivery, the full fee is credited toward it. Greenlight designs and advises; it doesn't build or configure your systems.
Start the audit
An outside view of your workflow, in a week.
Card, bank transfer or invoice. Every report reviewed by John before it reaches you.