Clinical Research Operations Advisory

Salesforce Workflow Visibility
for Clinical Research Operators

Greenlight Advisory helps integrated site networks, decentralized research organizations, and hybrid operators assess how Salesforce supports the full path from prospecting and feasibility through startup, recruitment, and First Patient In.

Most Salesforce issues in clinical research are not just CRM issues. They are workflow visibility issues between sales, operations, startup, and enrollment.

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The clinical research lifecycle — prospecting to First Patient In
01ProspectingPursuit
Sponsor/CRO targeting · therapeutic fit · account intelligence
Strategic Fit
02Opportunity / RFP IntakeIntake
RFP/Protocol intake · CDA tracking · service model · deadlines
Intake Discipline
03FeasibilityFeasibility
Patient access · site/service feasibility · enrollment assumptions · risk
Decision Support
04Proposal, Budget & ContractingContracting
Scope · pricing · budget assumptions · CTA/MSA/work order
Commercial Alignment
05Site / Service Activation PlanningPlanning
Site selection · service model design · team · vendor readiness
Execution Planning
06Study StartupStartup
Regulatory · IRB/IEC · essential docs · SIV · systems access
Activation Readiness
07First Patient In / Enrollment LaunchLaunch
First screened · enrolled · randomized · dosed · enrollment visibility
FPI Visibility
Serving Integrated Site Networks (ISNs) Decentralized Research Organizations (DROs) Hybrid Site Networks Salesforce Admins in Life Sciences
The 30-Second Version
We help integrated site networks, DROs, and hybrid operators build the Salesforce systems that run decentralized clinical research operations — from the first RFP/Protocol through feasibility, study startup, regulatory, recruitment, and enrollment visibility. The full lifecycle — prospecting to First Patient In. Built by people who have lived them.

Not ready for a full engagement?
Start with the Free Strategy Guide.

See how well your current Salesforce setup supports the full clinical research lifecycle — from prospecting to First Patient In. The guide helps you assess stage-by-stage coverage, spot workflow gaps, and determine what foundation needs to be in place before automation or AI can accelerate your operations.

Instant PDF delivery Get the Free Strategy Guide →

Every handoff that matters —
visible through Salesforce.

This is the clinical research lifecycle, mapped to the Salesforce objects, fields, and automation that should support it. This is the full path from prospecting to First Patient In. Expand any stage to see the milestones, architecture, and automation that should support it.

The framework is a workflow sequence, not a universal timeline — actual timing varies by protocol, geography, sponsor/CRO process, regulatory path, contract cycle, and site/service readiness. Greenlight = a site, service, or study workflow operationally ready to begin enrollment, per your defined activation criteria. First Patient In (FPI) may mean first consented, screened, enrolled, randomized, or dosed depending on the sponsor.

01

Prospecting

Sponsor/CRO targeting through strategic pursuit decision
Early pursuit
Automation
Clinical Milestones
  • Target sponsors, CROs, and studies identified
  • Therapeutic-area and strategic fit assessed
  • Opportunity logged in the commercial pipeline
  • Account intelligence and relationship history reviewed
  • Pursuit priority and go-forward decision documented
Salesforce Architecture
  • Opportunity (pipeline) — sponsor, CRO, therapeutic area, pursuit stage
  • Account (Sponsor / CRO record type) — relationship + prior engagements
  • Target-study pipeline report and pursuit-priority field
  • Record-type structure separating pursuit from operational study
Automation & AI
  • Pursuit prioritization scoring on the Opportunity
  • Sponsor / CRO activity summaries
  • AI: account-fit scoring against your strategic focus
02

Opportunity / RFP Intake

RFP/Protocol synopsis intake and CDA tracking
Intake
AutomationAI Candidate
Clinical Milestones
  • RFP / Protocol Synopsis received and logged
  • Service model requested captured
  • Buyer needs and submission deadline recorded
  • CDA sent, signed, and expiry tracked
Salesforce Architecture
  • Clinical Study (or Study Intake) record created at the qualification point
  • CDA object — sent, signed, expiry fields
  • Protocol Synopsis attachment handling
  • Intake-completeness flags
Automation & AI
  • CDA expiry reminder flow — automatic notification
  • AI: protocol synopsis analysis — extract key parameters
  • AI: missing-intake-information detection
03

Feasibility

Network feasibility through go/no-go decision
Feasibility
AI-Ready
Clinical Milestones
  • Feasibility survey distributed across the network
  • Site responses captured and scored
  • Patient prevalence and timeline estimates compiled
  • Competing-trial burden assessed per site
  • Operational risk and go/no-go decision documented
Salesforce Architecture
  • Feasibility Survey object — site responses, scores
  • Site Profile — reusable feasibility intelligence across studies
  • Complexity Score formula field
  • ACV calculation logic and enrollment-assumption fields
Automation & AI
  • Feasibility survey distribution triggered by stage change
  • Auto-calculate complexity score on save
  • AI: site/service matching — score network against protocol
  • AI: feasibility risk summaries
04

Proposal, Budget & Contracting

Scope and pricing through executed CTA
Contracting
High Automation ValueCommitment Handoff
Clinical Milestones
  • Proposal scope and pricing defined
  • Budget assumptions and enrollment commitment locked
  • CTA / MSA / Work Order negotiated and executed
  • Startup-fee trigger confirmed
Salesforce Architecture
  • Clinical Trial Agreement (CTA) object — status, execution date
  • Work Order / Budget object — version, approval routing
  • Enrollment-commitment field carried forward into operations
  • Base contract value locked for ACV reporting
Automation & AI
  • Budget approval routing flow
  • Contract cycle-time stopwatch (draft → execution)
  • AI: proposal assumption checks
  • AI: budget-risk flags
05

Site / Service Activation Planning

SSV and qualification through activation plan
Planning
AI-ReadyExecution Planning
Clinical Milestones
  • Site / service model matched to protocol requirements
  • Site Selection Visit (SSV) — remote or in-person
  • PI suitability, availability, and GCP status confirmed
  • Infrastructure, staff, and vendor/service readiness evaluated
  • Team assignment and workflow ownership defined
  • Qualification decision documented
Salesforce Architecture
  • Site record (Account) — infrastructure, staff, equipment fields
  • SSV milestone object — date, type, outcome
  • PI Contact record — CV, certification, availability
  • Site Qualification Scorecard — composite scoring
  • Study-Site junction object with per-site status
  • Vendor / service readiness fields
Automation & AI
  • SSV scheduling notification to the site coordinator
  • PI commitment follow-up if no response in a set window
  • Auto-update site status when qualification criteria met
  • AI: site/service performance prediction from history
  • AI: PI matching against protocol therapeutic area
06

Study Startup

Regulatory and IRB/IEC through site greenlight
Startup
High Automation ValueGreenlight Moment
Clinical Milestones
  • Regulatory packet compiled — Form 1572, CVs, financial disclosure
  • IRB / IEC submission and approval
  • Essential documents complete per site
  • Site Initiation Visit (SIV) — GCP, protocol, EDC training
  • Systems access and recruitment setup complete
  • Site activated — greenlight confirmed
Salesforce Architecture
  • Regulatory Packet object — completeness checklist per site
  • IRB / IEC Submission object — date, approval, expiry
  • SIV Milestone — scheduled, completed, training attestation
  • Activation % formula — units meeting activation criteria ÷ total selected
  • Greenlight dashboard — real-time portfolio view
Automation & AI
  • Regulatory packet completeness check — auto-flag missing docs
  • IRB submission deadline reminder flow
  • SIV scheduling triggered when IRB approval is received
  • Greenlight notification to the enrollment team on activation
  • AI: IRB timeline prediction from historical data
07

First Patient In / Enrollment Launch

Recruitment and screening through enrollment visibility — operational layer only. Subject-level clinical data, adverse events, eConsent, randomization, and trial-supply activity stay in the validated source systems (EDC, eTMF, eConsent, IRT/RTSM, safety/PV) unless the organization has confirmed the required privacy, security, validation, audit-trail, and contractual controls.
Launch
AI-ReadyVisibility Only
Clinical Milestones
  • Recruitment campaigns live by site and channel
  • Pre-screening and I/E evaluation; failures logged (aggregate)
  • ICF reviewed and signed; screening visit conducted
  • Patient enrolled and randomized into trial arm
  • First screened / enrolled / randomized / dosed captured per the sponsor's FPI definition
Salesforce Architecture
  • Recruitment Campaign object — channel, site, lead volume
  • Pre-Screen record — pass/fail, reason codes, attribution
  • ICF tracking — aggregate milestone status, no PHI
  • Screen Failure log — reason codes, counts per site
  • Enrollment record + dashboard — velocity, forecast vs. actual
Automation & AI
  • Pre-screen pass/fail scoring against I/E criteria
  • Enrollment velocity alert when a site falls below target
  • AI: enrollment velocity forecasting vs. protocol timeline
  • AI: screen-failure pattern detection where data supports it

Two services. Equal weight.
Both start with a conversation.

Whether you're building these clinical research workflows from scratch or need an outside expert to audit what you've already built — this is where the work starts.

Most engagements start with the Audit.

It's the lowest-risk way in: a fixed-fee, 48–72 hour read on where your Salesforce stands across the clinical research lifecycle. If you move into Advisory & Architecture within 14 days, the full $2,500 is credited toward your engagement — so the diagnosis effectively becomes step one of the build.

Same lifecycle view, two ways in. The Audit is a fast, fixed-fee read on what you already have — and the natural on-ramp to Advisory, since its fee credits toward the engagement. Advisory is hands-on design of the system end to end.

Outside Audit
$2,500
Flat fee · 48–72 hr delivery
Clinical Research Salesforce Workflow Audit
Advisory & Architecture
Priced by Scope
Defined after your audit · monthly & project-based options
Clinical Research Operations Advisory
Best for
You already have clinical research workflows in Salesforce and want an independent, expert second opinion on whether it's built right.
You're designing or rebuilding clinical ops in Salesforce and want it architected correctly across the full lifecycle from the start.
Engagement
One-time, fixed scope. Structured intake questionnaire — no Salesforce access required.
Ongoing monthly advisory. Full design, prioritization, and roadmap across the entire lifecycle.
Full lifecycle coverage
Reviewed — CDA, feasibility, SSV, IRB, CTA, SIV milestone tracking assessed
Designed — full architecture built across the lifecycle
Salesforce architecture
Gap analysis only — flags where objects, fields, or logic are missing or misbuilt.
Clinical Study object, Site Progress Tracker, CDA / IRB/IEC / CTA / Regulatory Packet object design
Automation & AI
AI-readiness score (0–100) with specific prerequisites
SSV/SIV automation, pre-screen tracking, enrollment velocity dashboards, ACV calculation logic, AI readiness across all stages
Greenlight visibility
Pipeline visibility & ACV logic assessed for gaps.
Real-time greenlight pipeline across all sites, built into the design
Deliverable
Prioritized 30-day improvement roadmap + 60-minute executive review call.
Precise technical blueprint, object schema, and execution roadmap your internal Admin runs.
Who executes
Your team, using the audit as a build checklist.
Your internal Admin or any Salesforce resource — no build dependency on Greenlight.
Start here to de-risk the decision — the full $2,500 credits toward Advisory if you engage within 14 days.
Learn About the Audit →
You own the recommendations, architecture, and roadmap. Your team executes — no build dependency on Greenlight.
Learn About Advisory & Architecture →

Applied at the right stage.
Not everywhere.

Every stage of the clinical research lifecycle has specific automation and AI opportunities. The advisory work maps each one and identifies what to build now, what to build later, and what needs clean data architecture before either is possible.

🎯

Prospecting Intelligence

Account-fit scoring against your strategic focus, sponsor/CRO activity summaries, and pursuit prioritization on the pipeline.

Stage 1 · Decision Support
📄

Intake & CDA Automation

Structured RFP/protocol intake, CDA expiry reminders, protocol-summary and key-field extraction, and missing-information detection.

Stage 2 · Flow + AI
🔬

Feasibility Scoring

Feasibility scorecards, site/service matching against the protocol, complexity scoring, and feasibility risk summaries.

Stage 3 · AI-Ready
📝

Contracting Checks

Proposal assumption checks, budget-risk flags, contract cycle-time tracking, and approval routing.

Stage 4 · Flow + AI
🗂️

Activation Planning

Award-to-operations handoff checklists, ownership matrices, and vendor/service readiness tracking.

Stage 5 · Flow Automation

Startup & Greenlight

Regulatory packet completeness, IRB/IEC milestone reminders, SIV triggers on approval, and real-time activation dashboards.

Stage 6 · Critical Path
🤖

Enrollment Visibility

Enrollment velocity alerts, forecasting vs. protocol timeline, and screen-failure pattern detection — where clean data and governance support it.

Stage 7 · Requires Clean Data
The Advisory Principle

"Fix the foundation. Automate the critical path. Apply AI where the data earns it."

Clinical research has a defined critical path — CDA to SSV to IRB to SIV to Greenlight to First Patient In. Every day lost on that path delays the study. The advisory work targets automation at exactly the handoffs and notifications that cause the most delay in practice.

AI comes later — and only where the underlying data is structured correctly. Enrollment forecasting requires clean historical enrollment records. Site matching requires structured site performance data. You cannot skip to AI before the objects and relationships are right.

  • Stage 1: Automate feasibility distribution and CDA tracking
  • Stage 2: Automate SSV scheduling and PI follow-up
  • Stage 3: Automate regulatory completeness checks and IRB reminders — highest ROI
  • Stage 4: Automate pre-screening scoring and velocity alerts
  • Stage 5: Apply AI to enrollment forecasting once data foundation exists

Salesforce architecture,
sub-specialized in clinical research.

Every milestone on this page reflects direct, lived experience with the operational reality behind it — Salesforce architecture sub-specialized in the integrated site network, DRO, and hybrid-operator systems that run decentralized clinical research, built from firsthand work inside a large-scale, tech-enabled decentralized research network operating 200+ locations across decentralized and hybrid trial models.

🧬

Real inside experience — not adjacent knowledge

This is not clinical research knowledge assembled from research. It is Salesforce architecture sub-specialized in this category — clinical study tracking, site activation workflows, geotargeted patient sourcing, and multi-location enrollment visibility — built from hands-on work inside a large-scale, tech-enabled decentralized research network, learning firsthand what breaks, what scales, and what should be built differently.

🗺️

Full lifecycle coverage — from prospecting to First Patient In

Most Salesforce consultants build the opportunity pipeline and stop. This practice covers the full lifecycle — including the contracting and activation-planning handoffs after award, the regulatory and startup complexity of activation, the recruitment pipeline, and the enrollment visibility layer.

🚫

No software to sell. No conflict of interest.

No AppExchange commissions. No vendor relationships. No preferred tools requiring additional licenses. Every recommendation is based solely on what is right for your clinical research operations. Includes direct experience supporting decentralized and hybrid trial models — site activation workflows and multi-location enrollment visibility.

Clearer build plans — not longer engagements

The audit delivers in 48–72 hours. The advisory engagement produces a roadmap your team executes. The goal is getting your clinical operations running correctly — not creating an ongoing configuration dependency.

The Advisory Model
"Advisory work — not configuration. You get the architecture, the schema, and the roadmap. Your team owns the build."
This is advisory work — not Salesforce configuration. The deliverable is a specific architecture, clear recommendations on where automation and AI belong at each stage, and a roadmap your team executes. And you don't need a Salesforce architect on staff to act on it: the deliverable is a precise technical blueprint and object schema — fields, relationships, automation logic, and build sequence spelled out — so any Salesforce resource, internal or contract, can execute it with enough specificity to build confidently. For organizations that already have something built, we come in as an outside auditor and give an honest independent assessment of what's working and what isn't.
  • Full lifecycle coverage — prospecting through First Patient In
  • Clinical terminology fluent — CDA, SSV, IRB, SIV, ICF, greenlight
  • Independent — no vendor relationships, no software commissions
  • Salesforce architecture, sub-specialized in the integrated site network, DRO, and hybrid-operator vertical

Structured. Fast. Specific.

The engagement produces a clear, actionable output — not a report full of observations. You'll leave knowing exactly what to build, in what order, and where automation and AI belong across the clinical research lifecycle.

01
Free · Day 0
Discovery Call
20 minutes. Which stages are covered in Salesforce today? Where are the gaps — feasibility handoffs, IRB tracking, site greenlight visibility? Establishes the right engagement.
02
Day 1
Structured Intake
Detailed questionnaire mapped to the full lifecycle. Every milestone — CDA, SSV, IRB, SIV, pre-screen, enrollment — assessed against what's currently in Salesforce. ~25 minutes.
03
Day 2–4
Assessment & Roadmap
Stage-by-stage gap analysis. Specific object recommendations, automation priorities by stage, AI readiness score, and a 30-day roadmap tied to your most urgent study go-live pressure.
04
Day 5–7
Executive Review
60-minute debrief. Walk through findings stage by stage, pressure-test the roadmap, align on what gets built first. Your team leaves with a specific, executable plan.

Let's talk about
getting your studies
to greenlight faster.

If your organization is looking to get studies to activation faster, design the right Salesforce infrastructure, or get an independent outside view of what you already have — that's the conversation. 20 minutes. No pitch.

🌐
Websitegreenlightadvisory.io
📅
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