Greenlight Advisory

For site networks, DROs & hybrid operators

Clinical Research Sales & Operations Advisory

Site networks rarely lose studies on the science. They lose them in the handoffs: an RFP nobody logged, a CDA that lapsed, a site that was ready on paper until the SIV. We fix the workflow from first sponsor contact to First Patient In.

Win more of the right studies and get them enrolling sooner.

Prefer to talk first? Book a 20-minute call

Serving

Integrated Site Networks (ISNs)

Decentralized Research Organizations (DROs)

Hybrid Site Networks

Clinical Ops & Systems Teams

Built for scale, not just pipeline

We design the sales and operations workflow behind a site network’s growth: how studies are found, qualified, priced, contracted, activated and launched. The aim is more of the right studies, moving faster, on a process that still holds at twice the size.

Most CRM consultants stop at the opportunity pipeline. The expensive delays come after the award: contracting, regulatory packets, IRB, the SIV, and the weeks between greenlight and first patient that nobody can account for. That is where we spend most of our time.

Not ready to talk? Check your own workflow first.

The free Workflow Guide walks the seven stages and asks what you track at each one, who owns the handoff, and what has to be true before automation is worth building. Most teams find their first gap in ten minutes.

Instant PDF delivery

Get the Free Workflow Guide

The Lifecycle

Every handoff that matters, visible to the people who need it.

Seven stages, from first sponsor contact to First Patient In. The tools matter less than you would think: a CRM, a CTMS and a shared spreadsheet all fail the same way when nobody owns the handoff. Open a stage to see what should be happening in it and what you should have in hand when it is done.

This is a sequence, not a timeline; protocol, geography, sponsor process and contract cycle all move the dates. Greenlight means a site, service or study is ready to enroll under your own activation criteria. First Patient In may mean first consented, screened, enrolled, randomized or dosed, depending on the sponsor.

01 ProspectingChoosing which sponsors and studies are worth the effort

Most networks prospect from memory, usually the last sponsor the BD lead spoke with. Good prospecting starts with a list of sponsors and CROs you actually fit, by therapeutic area and phase, and a record of every prior study and conversation with each.

Write the decision to bid down, with the reason, so nobody relitigates it next quarter. And keep a hard line between studies you are chasing and studies you have won. Mixing the two is how forecasts inflate.

What you should have

  • Target accounts ranked by therapeutic fit
  • Go / no-go decision with the reason on record
02 Opportunity / RFP IntakeThe moment a study becomes real work

Once a study qualifies it needs one intake record, not an email thread. The protocol synopsis lives with the study. The CDA is tracked from sent to signed to expiry, because an expired CDA quietly blocks the protocol you are waiting on. A short checklist shows what is still missing before feasibility can start.

What you should have

  • Intake record with deadline and service model
  • CDA status and expiry on every open study
  • Missing-information checklist
03 FeasibilityCan you actually enroll it?

Feasibility is where networks overpromise. Each site answers from its own memory of its own patients, and nobody checks the number against last year’s enrollment. Score site responses the same way every time, keep site profiles you can reuse from study to study, and write down the assumptions behind any number you send a sponsor. Those assumptions become your contract commitment.

What you should have

  • Site responses, scored the same way every time
  • Reusable site profiles
  • Protocol complexity score
  • The enrollment assumptions behind each estimate
04 Proposal, Budget & ContractingTurning a yes into a signed CTA

The enrollment number you commit to here is the number operations will be judged against, so it has to reach them exactly as signed. Keep every budget and work-order version and who approved it. Time the contract from first draft to execution. Most networks have no idea how long theirs takes until they measure it.

What you should have

  • Executed CTA, MSA or work order
  • Signed enrollment commitment, handed to operations
05 Site / Service Activation PlanningDeciding who runs it, and confirming they can

After award the study moves from the people who sold it to the people who will run it, and that handoff is where context gets lost. Confirm the PI’s availability and GCP status, the site’s staff and equipment, and every vendor the protocol depends on. Every one of those gets an owner and a date.

What you should have

  • Qualification scorecard for each site
  • SSV date, type and outcome
  • An owner and a date for every readiness item
06 Study StartupRegulatory, IRB and SIV, through greenlight

This is the critical path and the stage with the most recoverable days. A regulatory packet stalls on one missing CV. IRB approval lands and nobody schedules the SIV for a week. Leadership asks which sites are ready and gets a different answer from each person.

A packet checklist per site, deadline reminders, and one activation view everybody reads from fix most of it.

What you should have

  • Regulatory packet checklist for each site
  • IRB / IEC submission, approval and expiry dates
  • SIV scheduled, held and signed off
  • Activation percentage leadership can check on any day
07 First Patient In / Enrollment LaunchRecruitment and screening through enrollment visibility

Greenlight is not the finish line. Track recruitment by channel and site, pre-screen outcomes with reason codes, and screen failures in aggregate. Compare enrollment to the forecast every week, so a slow site is caught in week two instead of month three.

Operational tracking only. Subject-level clinical data, adverse events, eConsent, randomization and trial supply stay in your validated systems (EDC, eTMF, eConsent, IRT/RTSM, safety) unless the required privacy, security, validation, audit-trail and contractual controls are confirmed.

What you should have

  • Enrollment velocity, forecast against actual
  • Screen-failure reasons by site, in aggregate

Services

Start with the audit.
Stay for the design.

The audit tells you where your workflow breaks. Advisory designs what replaces it. Most clients do the first, then the second.

Most engagements start with the Audit.

A fixed fee, delivered in 48 to 72 hours: a stage-by-stage read on how your workflow holds up. Move into Advisory & Workflow Design within 14 days and the full audit fee is credited toward the engagement, so the diagnosis becomes the first step of the design.

Compare

Same seven stages, two ways in. The audit reads what you already have. Advisory designs the workflow end to end.

Outside Audit

$2,500

Flat fee · 48–72 hr delivery

Clinical Research Sales & Operations Workflow Audit

Advisory & Workflow Design

Priced by Scope

Defined after your audit · monthly & project-based options

Clinical Research Operations Advisory

Best for
AuditYou already track clinical research work in a CRM, CTMS, or spreadsheets and want an expert second opinion on whether it holds up.
AdvisoryYou're designing or rebuilding your sales and operations workflow and want it set up right across the full lifecycle from the start.
Engagement
AuditOne-time, fixed scope. Structured intake questionnaire — no system access required.
AdvisoryOngoing monthly advisory. Full design, prioritization, and roadmap across the entire lifecycle.
Full lifecycle coverage
AuditReviewed — CDA, feasibility, SSV, IRB, CTA, SIV milestone tracking assessed
AdvisoryDesigned — the full workflow mapped across the lifecycle
Workflow & data model
AuditGap analysis only — flags where stages, fields, handoffs, or owners are missing or unclear.
AdvisoryStudy and site tracking, handoff design, and what to capture for CDA, IRB/IEC, CTA, and regulatory packets
Automation & AI
AuditAI-readiness score (0–100) with specific prerequisites
AdvisorySSV/SIV automation, pre-screen tracking, enrollment velocity dashboards, ACV calculation logic, AI readiness across all stages
Greenlight visibility
AuditPipeline visibility & ACV logic assessed for gaps.
AdvisoryReal-time greenlight pipeline across all sites, built into the design
Deliverable
AuditPrioritized 30-day improvement roadmap + 60-minute executive review call.
AdvisoryDetailed workflow design, data model, and build roadmap your own team or vendor carries out.
Who executes
AuditYour team, using the audit as a build checklist.
AdvisoryYour internal admin, systems team, or whichever vendor you use — no build dependency on Greenlight.

Start here to de-risk the decision — the full fee credits toward Advisory if you engage within 14 days.

Order Audit

You own the recommendations, workflow design, and roadmap. Your team executes — no build dependency on Greenlight.

Learn About Advisory & Workflow Design

Automation & AI

Applied at the right stage.
Not everywhere.

Automation pays off at the handoffs that cause the most delay. AI pays off only where the data underneath it is clean. The work is deciding which is which at each stage, and leaving the rest alone.

Stage 02

Intake and CDA

Structured RFP and protocol intake, CDA expiry reminders, key protocol fields pulled from the synopsis, and a flag when intake information is missing.

Stage 03

Feasibility

Surveys sent the moment a study reaches feasibility, responses scored automatically, and sites matched to the protocol once you have structured site data.

Stage 04

Contracting

Budget approval routing, proposal assumptions checked against the feasibility record, and a running clock from first draft to signature.

Stage 06

Startup and greenlight

Regulatory packet completeness checks, IRB reminders, the SIV scheduled when approval arrives, and a live activation view. Usually the largest return of anything here.

Stage 07

Enrollment

Velocity alerts first. Forecasting and screen-failure patterns later, once there is enough clean history to trust them.

Not ready to talk? Check your own workflow first.

Get the Free Workflow Guide

The order we build in

Fix the foundation. Automate the critical path. Use AI where the data has earned it.

Clinical research has a defined critical path: CDA, SSV, IRB, SIV, greenlight, First Patient In. Every day lost on it is a day the study is late. Automation goes first at exactly those handoffs.

AI comes after, and only where the records support it. Enrollment forecasting needs clean enrollment history. Site matching needs structured site performance data. Skipping ahead produces confident answers built on bad data.

  • Intake: CDA expiry reminders and the intake checklist
  • Feasibility: survey distribution and scoring
  • Activation planning: SSV scheduling and PI follow-up
  • Startup: packet checks and IRB reminders, usually the biggest return
  • Enrollment: velocity alerts now, forecasting once the history is there

Why Greenlight Advisory

We ran this work
before we advised on it.

Everything on this page was learned running studies inside a large decentralized research network, across decentralized and hybrid trial models. We have watched studies stall because one CV was missing from a regulatory packet, because IRB approval landed on a Friday and nobody owned the SIV, because three people kept three versions of the enrollment forecast. None of that is a software problem. It is a workflow nobody designed.

The Advisory Model

We design it. Your team builds it.

Greenlight does not configure your systems. You get the stages, fields, handoffs, owners, automation logic and build order, written specifically enough that any admin or vendor, internal or contract, can build from it without guessing. If something is already in place, we audit it and tell you plainly what works and what doesn’t.

  • Prospecting through First Patient In
  • Fluent in CDA, SSV, IRB, SIV, ICF and greenlight, without translation
  • Integrated site networks, DROs and hybrid operators

01

Most of the work is after the award

Most CRM consultants build the opportunity pipeline and leave. The expensive delays come later: contracting, activation planning, regulatory, IRB, the SIV and recruitment. We cover all of it, because that is where the days go.

02

Your tools stay

A stage can live in a CRM, a CTMS, a spreadsheet or someone’s inbox. We map where it lives today, who owns each handoff and what leadership can actually see, then fix the gaps in whatever you already run.

03

Short engagements, specific output

The audit arrives in 48 to 72 hours. Advisory ends in a build plan your own team carries out. We would rather you not need us a year from now.

04

The same experience, built into software: TrialCurrent

Greenlight Advisory is also the company behind TrialCurrent™, the Clinical Research Sales & Operations Platform. Greenlight advises on how the workflow should run. TrialCurrent runs it, for networks that want it built in.

Explore TrialCurrent

How It Works

About a week, start to finish.

Four steps. You finish knowing what to build, in what order, and where automation belongs. Not a report full of observations.

  1. 01Day 0

    Order and pay

    Pay by card, bank transfer or invoice. The intake link arrives as soon as payment clears. Want to talk first? A 20-minute call is free.

  2. 02Day 0–1

    Complete the intake

    A questionnaire mapped to all seven stages: CDA, SSV, IRB, SIV, pre-screening and enrollment, each against how you track it today. About 30 minutes, no system access.

  3. 03Day 2–4

    Receive the report

    A stage-by-stage gap analysis, tracking and handoff recommendations, automation priorities, an AI-readiness score and a 30-day roadmap, 48 to 72 hours after your intake.

  4. 04Day 5–7

    Optional review call

    60 minutes on every finding, the roadmap and what gets built first. The report stands on its own if you skip it.

Contact

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

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

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greenlightadvisory.io
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