SITE STRATEGY / OPERATING TOOL 07

A New Site Network Adds Access.

New sites, provider networks, and patient-recruitment partnerships can increase reach. But unless the handoffs between cohort discovery, recontact, consent, screening, enrollment, and participant payment are operational, that new capacity may never translate into predictable enrollment. Use this checklist to activate the patient journey across your network.

Resources/Site strategy

Site Access Is Not the Same as Enrollment Capacity.

A CRO can sign:

  • a preferred site network,
  • a provider partnership,
  • a specialty-clinic relationship,
  • or a recruitment collaboration,

and still struggle to turn that access into enrolled participants.

Why?

Because access creates potential.

Operations creates conversion.

The network only becomes useful when the patient can move through this chain:

Cohort identified

→ Patient surfaced → Outreach owner assigned

→ Patient contacted

→ Pre-screened

→ Consent obtained

→ Eligibility evidence confirmed

→ Screened

→ Randomized

→ Milestone completed

→ Participant reimbursed/paid

If one of those transitions is unclear, the partnership can underperform even when the underlying patient population is strong.

5. The Site Network Activation Principle

Before asking:

“How many patients does this network give us access to?”

Ask:

“How many of those patients can we move compliantly and efficiently into a study?”

That is the difference between:

patient access

and

patient activation.

6. Activation Area 1 — Cohort Visibility

Objective

Make sure the network can identify the right patient populations.

Questions

What patient data can be queried?

Which fields are structured?

Can diagnosis be filtered?

Can disease stage be identified?

Can treatment history be identified?

Can medication history be queried?

Can biomarker or lab evidence be surfaced?

Can geography be included?

Can recent activity be detected?

Strong network

The network can estimate plausible study cohorts before site-level manual review.

Weak network

The partnership promises access to “thousands of patients,” but there is no reliable method for identifying likely candidates.

Activation red flag

The network measures total patient population rather than study-relevant patient population.

Output

Cohort Visibility Map

7. Activation Area 2 — Patient Identification

Objective

Translate protocol criteria into a workable candidate-identification process.

Ask

Who converts protocol inclusion/exclusion criteria into search logic?

Which criteria can be evaluated from available data?

Which require manual chart review?

Which require additional clinical evidence?

Can the network prioritize higher-probability candidates?

Strong workflow

Structured criteria narrow the candidate pool before coordinator effort.

Weak workflow

Sites receive large candidate lists and manually determine whether any patient is remotely suitable.

Activation red flag

Candidate volume increases, but coordinator productivity falls.

Output

Protocol-to-Cohort Mapping Sheet

8. Activation Area 3 — Referral Ownership

Objective Define who moves the patient once a likely candidate is found.

Questions

Who owns the next action?

The CRO?

The investigator?

The treating physician?

The site?

The network?

A recruitment vendor?

What happens if the candidate belongs to a provider outside the trial site?

Strong workflow

Each candidate has a clear next owner.

Weak workflow

Multiple parties can identify patients, but responsibility for progressing them is ambiguous.

Activation red flag

Patients are found but remain inactive because no party owns the transition.

Output

Referral Ownership Map

9. Activation Area 4 — Recontact Workflow

Objective

Create a reliable and compliant path from patient identification to outreach.

Ask Who can contact the patient?

Under what basis?

Is provider-mediated outreach required?

Does the patient need to opt in first?

Are there different rules by site or jurisdiction?

Can outreach status be tracked?

Strong workflow

Every candidate can move through a documented outreach pathway.

Weak workflow

The network can identify eligible-looking patients but cannot efficiently activate them.

Activation red flag

The network has strong cohort intelligence but weak recontact capability.

Output

Recontact Decision Tree

10. Activation Area 5 — Pre-Screening

Objective

Reduce unnecessary site effort before formal screening.

Ask

Can likely eligibility be assessed before the site spends substantial coordinator time?

Can missing evidence be identified?

Can basic exclusion factors be detected?

Can candidates be prioritized by probability?

Strong workflow The site receives a manageable number of plausible candidates.

Weak workflow

Every patient becomes a manual chart-review task.

Activation red flag

Network expansion increases coordinator workload faster than enrollment.

Output

Pre-Screen Readiness Checklist

11. Activation Area 6 — Consent & Permissions

Objective

Make consent operational across organizations.

Ask

Who obtains consent?

Which consent?

When?

What permissions are needed for:

  • study participation,
  • clinical data access,
  • source-data retrieval,
  • longitudinal follow-up,
  • optional research use?

Can permissions be changed or revoked?

Can the relevant parties see current consent status?

Strong workflow

Consent and permission are usable across the patient journey. Weak workflow

Consent exists, but every downstream party must manually verify whether it can proceed.

Activation red flag

The legal record exists but operational teams cannot confidently act on it.

Output

Consent & Permission Ownership Map

12. Activation Area 7 — Clinical Data Access

Objective

Ensure the network can support screening with the right evidence.

Potential data

Diagnoses

Labs

Imaging

Pathology

Genomics

Medication history

Prior treatments

Specialist notes

Longitudinal observations

Ask

Where does the evidence live?

Can it be accessed digitally? Does the patient need to retrieve records?

Do providers need to fax or email documents?

Does the site need to repeat testing?

Strong workflow

Eligibility evidence is available before or early in formal screening.

Weak workflow

The network finds patients, but the trial cannot efficiently verify them.

Activation red flag

The patient is discoverable but not clinically actionable.

Output

Clinical Evidence Availability Map

13. Activation Area 8 — Site Handoff

Objective

Move a promising patient into the trial site without losing momentum.

Measure

Candidate identified → referral

Referral → site acknowledgment

Site acknowledgment → contact

Contact → pre-screen

Pre-screen → screening

Ask

Can the network see what happened after referral?

Does the site acknowledge receipt? Are stale referrals escalated?

Is conversion visible by site?

Strong workflow

Referral status is visible end to end.

Weak workflow

The network sends candidates into a black box.

Activation red flag

The organization measures referrals sent but not referrals converted.

Output

Referral-to-Site Funnel

14. Activation Area 9 — Participant Experience

Objective

Make sure new network reach does not create new burden for the patient.

Ask

Where will the participant need to travel?

Can visits happen locally?

Can some activities be remote?

Who supports travel?

How are reimbursements handled?

Can the patient understand what happens after referral?

Strong workflow

The network expands reach without increasing avoidable participant burden. Weak workflow

Patients are identified far from trial sites with no practical pathway to participate.

Activation red flag

The network increases theoretical reach but not realistic participation.

Output

Patient Participation Feasibility Map

15. Activation Area 10 — Participant Payments

Objective

Design payment into the network workflow.

Ask

Which organization owns participant payment?

What triggers it?

Who verifies milestone completion?

Can reimbursement rules vary by site?

Can the network see payment status?

Can the participant see payment status?

Strong workflow

Payment follows verified study activity predictably.

Weak workflow

Sites must manually reconcile activity and finance.

Activation red flag New sites or network partners add another payment exception process.

Output

Participant Payment Ownership Map

16. Activation Area 11 — Network Reporting

Objective

Measure whether the network is actually improving enrollment.

Do not report only:

  • sites activated,
  • patients available,
  • referrals generated.

Track:

eligible-looking patients identified

patients contacted

patients pre-screened

patients screened

patients randomized

median referral-to-contact time

screen-failure rate

randomization rate by referral source

coordinator workload

Strong workflow

The network is measured by conversion.

Weak workflow The network is measured by activity.

Activation red flag

Leadership sees volume but not yield.

Output

Network Conversion Dashboard

17. Activation Area 12 — Escalation & Exception Handling

Objective

Design for the cases that do not follow the ideal path.

Examples:

Patient cannot be reached.

Consent expires.

Patient changes provider.

Records are unavailable.

Site does not respond.

Payment exception occurs.

Candidate crosses geography.

Study closes at one site.

Ask

Who owns the exception?

How is it escalated?

Can the network see it?

Does the patient get stuck? Strong workflow

Exceptions are visible and routed.

Weak workflow

Exceptions become email threads.

Activation red flag

The network works only when everything goes perfectly.

Output

Exception Escalation Matrix

18. The 12-Point Site Network Activation Checklist

Before calling the network operational, confirm:

  • Cohort visibility is defined
  • Protocol criteria can be translated into candidate logic
  • Referral ownership is clear
  • Recontact pathway is defined
  • Pre-screening is efficient
  • Consent and permission ownership is clear
  • Clinical evidence can be accessed
  • Site handoff is measurable
  • Participant burden is understood
  • Payment ownership is defined
  • Network conversion is reported
  • Exception handling is designed 19. Site Network Activation Score

Score each area:

Green

Clear, measurable, and operational.

Amber

Works, but depends on manual coordination.

Red

Unclear, fragmented, or not yet operational.

0–2 Red

Network is likely ready for scaled activation.

3–5 Red

Network has meaningful operational dependencies that should be addressed before aggressively scaling volume.

6+ Red

The partnership may currently provide access more than true recruitment capacity.

20. The Most Important Network Metric

Do not optimize:

referrals generated.

Optimize: randomized participants per 100 qualified referrals.

Supporting metrics:

  • referral → first contact time,
  • contact → pre-screen conversion,
  • pre-screen → screen conversion,
  • screen → randomization conversion,
  • cost per randomized participant.

That tells leadership whether the network is actually producing trial value.

21. 30 / 60 / 90 Day Activation Metrics

First 30 Days

Track:

  • workflow completion,
  • referral acknowledgment,
  • recontact success,
  • operational exceptions.

Goal:

Make the network observable.

Days 31–60

Track:

  • candidate conversion,
  • site response time,
  • pre-screen pass rate,
  • missing data,
  • consent friction.

Goal: Make the network predictable.

Days 61–90

Track:

  • randomized participants,
  • cost per randomized participant,
  • site productivity,
  • participant-payment turnaround.

Goal:

Make the network economically measurable.

Turn New Patient Access Into an Operating Enrollment Pathway.

Download the editable Site Network Activation Pack and use it with your:

  • Site Strategy team,
  • Patient Recruitment team,
  • Clinical Operations team,
  • Partnership team,
  • Clinical Technology team.

Download includes

  • 12-point activation checklist
  • cohort visibility worksheet
  • referral ownership map
  • recontact decision tree
  • site handoff funnel
  • consent/data map
  • participant payment map
  • 30/60/90-day network dashboard

CTA Button Download the Activation Pack

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COVER

THE SITE NETWORK ACTIVATION CHECKLIST

Turn new site capacity and patient access into enrolled participants.

For CRO Site Strategy, Patient Recruitment, Clinical Operations and Partnerships teams.

PAGE 2 — 12-Point Checklist

AreaGreenAmberRed
Cohort visibility
Protocol-to-cohort logic
Referral ownership
Recontact workflow
Pre-screening
Consent/permissions
Clinical evidence access
Site handoff
Participant feasibility
Payment workflow
Network reporting
Exception handling

Number of Red items:

PAGE 3 — Cohort Visibility Worksheet

Therapeutic area

Study population

Data available

  • Diagnosis
  • Stage/severity
  • Treatment history
  • Medication
  • Labs
  • Imaging
  • Biomarkers
  • Geography
  • Longitudinal history

Can likely eligible patients be identified before manual site review?

Yes / Partly / No

Primary limitation: PAGE 4 — Referral Ownership Map

Event Owner Backup Owner Syste SLA m

Candidate identified

Candidate reviewed

Referral created

Outreach assigned

Patient contacted

Pre-screen completed

Site receives candidate

PAGE 5 — Recontact Decision Tree

Patient identified by:

  • Trial site
  • Treating provider
  • Health system
  • External network
  • Recruitment vendor
  • Other

Who is allowed to contact the patient?

Is patient opt-in required first?

Yes / No / Depends

Can outreach status be tracked?

Yes / Partly / No Primary recontact risk:

PAGE 6 — Site Handoff Funnel

Stage Volume Conversio Median Time n

Candidate identified

Referred

Site acknowledged

Contacted

Pre-screened

Screened

Randomized

Largest drop:

Longest delay:

PAGE 7 — Consent & Data Map

Consent owner:

Data-access owner:

Can current consent state be seen across organizations?

Yes / Partly / No

Can permissions change or be revoked? Yes / Partly / No

External clinical data required?

Yes / No

Main data-access bottleneck:

PAGE 8 — Payment Map

Who verifies milestones?

Who approves payment?

Payment rail:

Median milestone → payment time:

Are sites handling manual exceptions?

Yes / No

Main source of friction:

PAGE 9 — 30/60/90 Dashboard

Day 30

Referral acknowledgment: __________

Recontact success: __________

Median first-response time: __________ Day 60

Pre-screen conversion: __________

Screen-failure rate: __________

Missing-evidence rate: __________

Day 90

Randomized participants: __________

Cost per randomized patient: __________

Milestone-to-payment time: __________

Your Network Is Activated.

Now quantify where it is still leaking value.

Use the Cost-per-Randomized-Patient Leakage Calculator to estimate the impact of:
  • lost referrals,
  • screen failures,
  • coordinator work,
  • site latency,
  • manual consent/data handoffs,
  • participant-payment friction.
Run the Calculator

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