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Clinical Development & Trials
Patient Recruitment
Regulated development and commercialization journeys where clinical, quality, and market access align.
Science 37
Medidata
Signant Health
Syneos Health
Inside this journey
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Pre-Discovery
Align the room on outcomes, decision process, and constraints before deeper discovery.
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Stakeholder Alignment
Confirm decision roles, timelines, enrollment targets, and what ‘on-time enrollment’ means to each stakeholder.
Alignment Questions
Tell Me Your Trial — Fast
- In one sentence, summarize the study we’d be helping with (indication, primary endpoint, and any unusually strict eligibility)
- Which phase is this study?
- What is the total planned randomized sample and the average target per active site?
- Where are you today on the timeline (site activation, first patient in, current enrollment rate)?
- How many calendar weeks or months are you from your originally planned primary completion date?
- Who on your team will be our main day-to-day contact for recruitment operations and escalation (name/title)?
Are You Settling for Slow Enrollment?
- If enrollment stayed exactly as it is today for the next 3 months, what would the impact be on the study and on you personally?
- How strong is the pressure from leadership to change approach versus stay the course?
- What would have to go wrong for leadership to escalate to a formal remediation plan?
- How does current enrollment shortfall make you feel when you prepare updates for executives (e.g., anxious, defensive, motivated to act)?
- What internal costs or risks are you most worried about if enrollment continues to lag (timeline, budget, regulatory, reputational)?
- What is the single most persuasive outcome that would get your team to approve an external recruitment approach quickly?
Where Are Patients Dropping Out — And Why It Matters
- Which funnel step is performing worst right now: referral, pre-screen, consent, or conversion to randomization — and why do you think that is?
- Do you have recent funnel metrics (referrals → pre-screens → consents → randomizations)? If yes, please paste or summarize the last 3 months.
- How consistently do sites log referrals and pre-screen outcomes into your CTMS or tracker?
- When a referred patient fails pre-screen, what are the top three reasons you hear from sites or coordinators?
- Are there competing trials recruiting the same patient population at key sites? If so, which competitor attributes (incentives, simpler protocol, faster visits) are winning patients?
- How would you rate the accuracy of site feasibility estimates submitted during study start-up?
Who Actually Decides — And Who’s Being Heard
- Who are the decision-makers and influencers for enrollment strategy (names/titles: e.g., CMO, clinical ops, biostatistics, legal, procurement)?
- If we proposed a new multi-channel recruitment program, which stakeholders would need to sign off before launch?
- How does each stakeholder define 'on-time enrollment' (e.g., primary completion by X date, % of sites hitting targets, median time-to-randomization)? Please list differences.
- What deadlines or milestones are non-negotiable (e.g., safety database lock, interim analysis date, regulatory submission)?
- Who will have final say on go/no-go decisions and what evidence do they require (conversion rates, cost per randomization, site performance)?
- How do you typically resolve conflicts when site priorities diverge from sponsor timelines?
If Enrollment Were Miraculously Fixed — What Would That Feel Like?
- Describe an outcome that would make the sponsor say this recruitment intervention 'worked' — the exact phrase they would use in the board meeting.
- What numerical KPIs must we meet to call the program successful (pick the primary three)?
- What is your target cost-per-randomized-patient range for a remediation program like this?
- How frequently would you want performance reporting (and what level of detail) to feel confident in our progress?
- Beyond numbers, what qualitative signals would make you feel this approach is changing the trajectory (site confidence, patient feedback, improved prescreen quality)?
- If we exceeded your expectations, what would you want documented and shared internally to lock in future support?
What's Already Been Tried — And What We Learned
- Which recruitment channels have you already used on this study (select all that apply)?
- For each channel that was used, which delivered acceptable results and which underperformed? Please give brief examples.
- Have you previously engaged third-party recruitment vendors? If yes, what were the top two reasons the relationship didn’t fully resolve the issue?
- Have any protocol or operational changes been attempted to boost enrollment (e.g., broaden eligibility, add sites, increase visits reimbursement)? What was the result?
- What lessons from past attempts should we never repeat or that we must replicate?
- What internal resources (site liaisons, call center, marketing approvals) are currently available to support an external recruitment partner at launch?
Data, Permissions, and Practicalities — Can We Move Quickly?
- How many sites have active EHR screening permissions in place and are willing to share patient-level identifiers for pre-screening?
- What IRB or legal constraints will govern advertising or direct-to-patient outreach for this protocol?
- Do sites have required tech integrations (CTMS, electronic referrals, API access) to enable referral tracking and attribution?
- Which data feeds would you be comfortable sharing to measure performance: de-identified referrals, site-level conversion rates, or patient-level outcomes?
- How fast could IRB-approved creative (ads, landing pages, consent scripts) realistically be reviewed and signed off?
- Are there any critical regulatory or privacy red lines we must avoid (e.g., no social media targeting, no PHI in outbound comms)?
What Would Make You Pull the Trigger — Timeline, Terms, and Evidence
- What short-term evidence (first 30 days) would you need to approve continued spend on a remediation campaign?
- Which commercial models are you open to exploring (fixed fee, performance-based, hybrid) and which would be a deal-breaker?
- What are the non-negotiables in your contract (data ownership, patient privacy, indemnity, audit rights)?
- Assuming terms are acceptable, how quickly could you sign and mobilize an external recruitment partner?
- What are your preferred acceptance criteria for a formal go/no-go after launch (quantitative thresholds and timeline)?
- Who needs to be present in a 30–45 minute launch-readiness call to greenlight activation?
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Current State Mapping
Document site performance, enrollment shortfalls, competing trials, eligibility bottlenecks, and available data sources.
Current State
Quick Snapshot: Where Things Stand Today
- How far behind target are you right now (absolute patients and percent of planned timeline)?
- What is the planned enrollment rate per month versus your current actual rate?
- Which trial locations (sites/regions) are meeting, exceeding, or missing targets — list top 3 that are underperforming and why you think that is.
- How long have you been tracking this shortfall, and what corrective actions have already been tried?
- If you had to assign a confidence score to your current ability to hit enrollment in the next 3 months, what would it be (0–10)?
Are Sites Really Who They Said They Were?
- Many feasibilities sound promising on paper — which site assumptions from feasibility have proven inaccurate?
- Which of the following best describes the main reason sites are underperforming?
- For the sites missing targets, how predictable are their shortfalls—are there repeatable patterns by day, week, or referral source?
- When underperformance occurs, what typically happens next—do sites escalate early, try local outreach, or wait for sponsor intervention?
- Describe a recent example of a site that turned from struggling to productive — what changed and who made it happen?
What's Eating Your Eligible Pool?
- Is the protocol excluding more patients than expected, and if so, where in the eligibility checklist are most failures happening?
- How often do competing trials target the same patient population in the same regions, and which competitors are most active?
- Which patient-level barriers are you seeing most frequently (transportation, cost, time, distrust, comorbidities)?
- How much of the screen fail volume is due to documentation/data gaps versus true clinical ineligibility?
- Tell us about any local referral sources (clinics, advocacy groups, specialty practices) that have been unexpectedly poor or unexpectedly strong.
Where Are Patients Getting Lost?
- Which step of the funnel (referral → pre-screen → consent → randomization) is breaking most often for you?
- Across channels (site outreach, digital ads, physician referrals, EHR screening), where do you see the biggest drop-offs and which channel underdelivers most?
- How well are you tracking referral-to-randomization conversion by channel and by site today?
- When a patient falls out of the funnel, what follow-up or re-engagement steps exist, and who owns them?
- Share a recent patient pathway that failed — where did they disengage, and what would have kept them in?
What Data Are You Truly Sitting On?
- Which of these data sources are available to us for screening, outreach, or analytics (select all that apply)?
- Do you have IRB or data-sharing permissions in place that would allow targeted messaging or EHR screening at participating sites?
- How accessible and clean is the data (examples: diagnosis codes, meds, lab values) for near-term cohort identification?
- What reporting cadence would be useful to you (weekly funnel, daily alerts for high-priority referrals, monthly summaries)?
- Are there legal, privacy, or site-specific constraints we should know about before proposing EHR or outreach tactics?
Who Owns What — Roles, Timing, and Decision Triggers
- If enrollment remains behind target, who at the sponsor/CRO makes the call to change strategy, and how quickly can that decision be executed?
- What are the concrete enrollment acceptance criteria (per site and overall) that will trigger incremental resourcing or a go/no-go decision?
- Who at each critical stakeholder group (sponsor, CRO, sites) will be our point of contact for rapid operational changes?
- How flexible are timelines for site activation, and what minimum notice do we have to deliver a campaign at a given site?
- Describe any recent internal decisions or political pressures that shape how aggressive you can be with outreach or incentives.
If We Did Nothing Different, What Happens?
- What are the tangible consequences if enrollment stays on this trajectory (timeline delays, additional cost, missed endpoints)?
- How tolerant is leadership to incremental budget spend to accelerate enrollment versus accepting a delayed timeline?
- What has been the internal reaction from investigators and sites to the under-enrollment—supportive, defensive, or disengaged?
- If enrollment falters further, what contingency plans exist (extend recruitment window, add sites, amend protocol)?
- Which of these outcomes is least acceptable to you — and why?
Quick Wins & Next Steps: Where We Can Move Fast
- If we prioritized three immediate actions to boost referrals this month, which would you choose?
- What short-term constraints would block any of those actions (IRB, budget, legal, site approvals)?
- How quickly can you provide pilot sites, contact lists, or data extracts for a rapid proof-of-concept?
- Who should be in the room for a 30–45 minute run-through of our initial plan and data requirements?
- What success signal from a 6–8 week pilot would make you feel confident to scale our approach?
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Customer Discovery
Align on the enrollment gap, target KPIs (referral→pre-screen→consent→randomization), constraints, and success signals.
Discovery Questions
Quick Snapshot: What's on your plate right now?
- How urgent is this enrollment shortfall to your overall program?
- Give a one‑sentence summary of the enrollment problem you're asking us to solve.
- Which phase and therapeutic area is this study?
- What therapeutic area and specific indication are you recruiting for?
- How many patients do you planned vs currently enrolled (please provide both numbers)?
- How many active sites are in the intent-to-enroll pool and how many are currently enrolling patients?
- How is this shortfall making the study leadership feel—what are the biggest emotional or political pressures you’re facing?
If I Could Only Fix One Thing, It Would Be…
- If there were a single, fixable cause behind most of your enrollment losses, what is it?
- How large is the enrollment gap at the site level vs centralized expectations (estimate percent shortfall by site)?
- Where in your funnel are you losing the most people: referrals, pre‑screen, consent, or randomization?
- Describe one patient story or specific screening failure that best illustrates the enrollment friction you're seeing.
- Which of the following operational bottlenecks are present right now?
- How consistently are your sites logging screening failures and reasons into CTMS or your tracker?
- Which stakeholder reactions have surprised you most (sponsor leadership, sites, IRB, patients)?
How Much of This Is Actually Controllable?
- What portion of the shortfall do you believe could be improved without changing the protocol?
- Which constraints currently force a protocol amendment to materially improve enrollment?
- What IRB or regulatory approvals would a recruitment campaign need before going live (e.g., central IRB OK, site‑level signoff)?
- Do you have EHR screening access at participating sites today, and what level of access is available?
- Which of these data feeds are available to support recruitment analytics?
- How quickly could sites enable EHR screening or integrate our referral portal if we needed it?
- What past internal fixes have moved the needle even a little—and why did they help?
Imagine the Enrollment Headline in 90 Days
- If the study were back on track in three months, what single headline would make you breathe easier?
- Set target funnel KPIs you’d require to call this a success (provide % for referral→pre‑screen→consent→randomization).
- What is your acceptable cost-per-randomized-patient (range) for a remediation program?
- How many randomized patients per week across the program would you need to see before leadership accepts the path forward?
- Which success signals would convince you to scale the program vs pause it?
- Who ultimately signs off that the enrollment remediation is successful (name role/title)?
- What would a minor vs major success look like to your CEO/Head of R&D?
The Work You've Already Tried (and What Surprised You)
- Which recruitment vendors or internal tactics have you used in the last 12 months for this study?
- Which channel delivered the most usable referrals previously (even if conversion was low)?
- Share one example where a vendor promised faster enrollment but didn’t deliver—what specifically failed?
- What vendor behaviors or deliverables did you value most when a campaign actually worked?
- When a prior campaign failed, what sign earlier on would have helped you stop and fix it sooner?
- How important is prior therapeutic-area experience in a vendor for you to move forward?
- What internal capabilities do you want to keep (vs hand off) when working with an external recruitment partner?
Decision Pressure, Commercial Tradeoffs, and Non‑Negotiables
- If things don’t improve in the next 8 weeks, which outcome is most likely?
- Which commercial structures are acceptable to you for a remediation program?
- Which contractual terms are deal‑breakers for you (choose all that apply)?
- What internal procurement or legal timelines should we expect to work within?
- What budget flexibility exists if initial pilots demonstrate impact?
- Are there any competing internal priorities or upcoming milestones that could block a fast decision?
- What commercial KPI(s) should be tied to payment in your view (e.g., cost-per-randomized, qualified leads, conversion rate)?
- Which financial stakeholders must be engaged before contracting (titles/roles)?
Signals, Reporting, and a Fast Path to 'Yes'
- What immediate evidence would make you stop searching and say, 'Start tomorrow'?
- Which metrics must be visible in our dashboard to keep you confident (pick top 3)?
- How often do you want live reporting and what cadence for strategic reviews?
- What data‑sharing permissions or integrations do we need to plan for up front (EHR queries, CTMS access, de‑identified patient data)?
- Which pilot scope would you consider appropriate to test our approach (sites only, DTP + sites, one country, multi‑site)?
- Realistically, what's your internal decision timeline if we present a proposal next week?
- What worries you most about bringing in a new recruitment partner? Tell us the specific fear.
- If you're comfortable, who would we meet next from your side to validate feasibility (name/role/email)?
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Solution Experience
Walk through how our multichannel pipeline (digital, physician, EHR, site support) converts referrals to randomizations in your trial context.
Experience Meetings
- Pre-Experience Alignment
- Pipeline Walkthrough — Live Scenario
- Channel Deep-Dive: Digital, Physician, EHR, Site Support
- Conversion Funnel Mapping & Tracking Workshop
- Validation & Commitment Checkpoint
- Set KPI targets and clear acceptance criteria for initial launch validation.
- Define each channel's tactical plan, ownership, and expected yield in measurable terms.
- Agree required IRB language and creative constraints per channel.
- Finalize tracking/attribution approach so every referral can be tied to channel and site.
- Confirm site vs DTP responsibilities and SLAs for referral follow-up.
- Seller to provide IRB-ready sample creative and draft messaging for sponsor review.
- Sponsor to list EHR systems per site and provide contact for EHR query integration.
- Seller to deliver channel-level projected conversion rates and expected volumes for the campaign.
- Designate a site liaison at sponsor side to coordinate site support processes.
- Funnel Definitions & Ownership
- Finalize funnel stage definitions and assign owners for each transition.
- Agree tracking implementation and data feeds that will prove conversion performance.
- Introductions & Objectives
- Complete a successful validation test demonstrating end-to-end traceability.
- Seller to deliver final tracking spec (tags, APIs, portal mappings) and sample dashboard within 5 business days.
- Sponsor IT/site teams to implement test EHR query and provide test record for validation exercise.
- Create a shared test-plan and schedule the live validation run.
- Agree the reporting cadence and recipients for ongoing campaign performance updates.
- Review of Preconditions and Validation Results
- Obtain sponsor confirmation that the validated pipeline satisfies the defined future-state outcome.
- Resolve or assign owners for any remaining risks or regulatory blockers.
- Agree on the channel mix, site responsibilities, KPI targets, and the next meeting to scope commercial terms.
- Create a clear, dated checklist for handoff to Solution Scope and Deployment stages.
- Sponsor to provide formal sign-off on the validated future-state statement and KPI targets.
- Seller to draft a preliminary SOW and channel scope document for review ahead of the Solution Scope meeting.
- Assign owners and deadlines for outstanding regulatory items and tracking implementation tasks.
- Schedule the Solution Scope meeting and share the sign-off checklist and required documents.
- Produce one clear current-state sentence capturing where enrollment is breaking.
- Quantify consequence in monetary or timeline terms for sponsor stakeholders.
- Agree a single measurable future-state outcome sentence (e.g., % lift in randomizations or reduced time-to-randomization).
- Confirm data sources, trial scenarios, and decision-makers required for the live walkthrough.
- Assign pre-work owners and deadlines so the Solution Experience can be tailored and data-driven.
- Sponsor provides site-level enrollment data, baseline referral→randomization rates, and list of prioritized sites.
- Sponsor supplies one or two exemplar patient personas and protocol eligibility constraints for the scenario.
- Seller provides template conversion model and requests access or anonymized sample records to populate it.
- Identify and confirm the decision-makers who must validate the Solution Experience outputs.
- Recap Preconditions
- Demonstrate, with the sponsor's data, that the pipeline can deliver the defined future-state outcome.
- Validate each pipeline handoff and assumption directly with sponsor stakeholders.
- Agree on expected channel-level conversion lifts and time-to-randomization estimates.
- Identify any fatal execution gaps that would prevent expected outcomes.
- Commit to the next technical/channel scoping sessions needed to operationalize the model.
- Seller to deliver a scenario-specific conversion model (referral→randomization) populated with sponsor data within 3 business days.
- Sponsor to validate and annotate eligibility constraints and confirm competing-trial impacts on the scenario.
- Seller to provide historical case studies and channel benchmarks that map to the sponsor's therapeutic area.
- Schedule channel deep-dive sessions and tracking workshop dates.
- Overview & Objectives
- Scenario Brief
- Current State Statement
- Baseline Rates & Target KPIs
- Impact Summary & Expected Deliverables
- Digital Channel (ads, landing pages, call center)
- Tracking Architecture
- End-to-End Pipeline Walkthrough
- Open Issues & Regulatory Considerations
- Physician Referral Activation
- Consequence Quantification
- EHR Screening & Site-Based Identification
- Future State Definition
- Sign-off Checklist & Next Milestones
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Solution Scope
Define channels, site vs DTP responsibilities, IRB-approved creative delivery, tracking, and measurable KPIs by site and channel.
Scope Configuration
- Produce IRB‑Compliant Ad Copy and Creative
- Launch Condition‑Specific Search Ad Campaigns
- Deploy Targeted Social Media Recruitment Campaigns
- Run Geo‑Targeted Digital Campaigns for Site Catchments
- Operate Patient Call Center Pre‑Screening
- Conduct Telephone Pre‑Screening and Eligibility Checks
- Implement Site EHR Patient Identification
- Operate Physician Referral Outreach Program
- Mine Patient Databases and Deliver Qualified Leads
- Build Trial Landing Page with Pre‑Screen Form
- Operate Referral Tracking Portal and Log Referrals
- Provide Referral-to-Randomization Conversion Reports by Channel and Site
- Manage Paid Media Budgets and Bid Optimization
- Deliver Site Handoff Packs with Qualified Patient Profiles
Scope Questions
Produce IRB‑Compliant Ad Copy and Creative
- Who will own IRB submission and approvals for advertising materials?
- Are there existing IRB templates, mandatory disclaimers or legal copy that must appear in all creatives?
- Which creative formats are required or preferred (select all that apply)?
- What languages and regional variations must ads support?
- Describe any therapeutic-area or protocol-specific claims or prohibitions that creatives must follow (e.g., no mention of placebo, no guaranteed benefit).
- What is the expected IRB turnaround time and number of revision cycles we should budget for?
Launch Condition‑Specific Search Ad Campaigns
- Which conditions/indications should search campaigns target (list primary and secondary)?
- Which search engines or platforms should we use?
- Do you have preferred or prohibited keywords/phrases (provide lists if available)?
- What geographic scope should search campaigns cover (global, country, state, site catchments)?
- What landing experience do you want for search traffic (central trial page, site-specific pages, direct contact)?
- What is the target CPA (cost-per-acquisition) or target referral conversion metric for search traffic?
Deploy Targeted Social Media Recruitment Campaigns
- Which social platforms should be included?
- Which audience segments should we target (patients, caregivers, advocacy group members, HCPs)?
- Are there age, gender, or demographic restrictions for social targeting?
- What creative formats should be used for social campaigns?
- Do social creatives require pre-approval by sponsor/site or IRB before launch?
- Are there restrictions around patient testimonials or use of PHI in social content?
Run Geo‑Targeted Digital Campaigns for Site Catchments
- Please list participating sites and their catchment radii (miles or km) for geo-targeting.
- Do you want geofencing (e.g., around clinics), zip/radius targeting, or broader DMA targeting?
- Are there areas to explicitly exclude from targeting (e.g., competing trial sites, sensitive locations)?
- Will site-level landing pages or site-specific CTAs be used for catchment traffic?
- Who is responsible for local site coordination when a geo-referred patient expresses interest?
- What performance KPIs do you expect for geo campaigns (e.g., referrals per site/week)?
Operate Patient Call Center Pre‑Screening
- What hours and days should the call center operate (include timezones)?
- Which languages must call center agents support?
- Should agents follow IRB‑approved scripts or can they use flexible conversational screening?
- What is the expected call disposition workflow (schedule site callback, send info pack, no follow-up)?
- Do you require call recording, QA monitoring, and transcripts stored for audit?
- What SLA do sites require for handoff after a qualified caller is identified?
Conduct Telephone Pre‑Screening and Eligibility Checks
- Who will perform clinical eligibility checks by phone (trained nurse, CRC, vendor clinician)?
- Which screening items are allowable by telephone before site visit (e.g., meds, diagnosis, basic labs)?
- Is verbal pre-screen consent acceptable for calls, or is documented written consent required prior to screening?
- What maximum call duration should we budget for an initial telephone pre-screen?
- Should telephone pre-screen results be entered directly into the portal/EHR or provided as a handoff file to sites?
- What minimum data elements must be captured during phone screening to qualify a referral?
Implement Site EHR Patient Identification
- Which EHR systems are used by participating sites (Epic, Cerner, Allscripts, other)?
- Will EHR queries be run by site staff, vendor with site access, or via a centralized EHR integration?
- Are there IRB or patient-consent constraints on contacting patients identified via EHR?
- What frequency should EHR matching run (one-time, daily, weekly, on-demand)?
- What data fields should be returned in matches (MRN, diagnosis code, recent labs, contact info, last visit date)?
- Do sites permit automatic export into the referral portal or must results be reviewed before export?
Operate Physician Referral Outreach Program
- Which physician groups or specialties should we prioritize for outreach?
- What outreach channels are acceptable (email, phone, in-person visits, mail, HCP portals)?
- Are there compensation or incentive programs for referring physicians that must be disclosed or managed?
- What materials should be provided to physicians (PDF intro pack, eligibility checklist, referral form, patient handouts)?
- How should physician referrals be transferred to sites (secure portal, fax, EHR message)?
- What KPIs should track physician program success (referrals/month, qualified referrals, conversions)?
Mine Patient Databases and Deliver Qualified Leads
- Which patient databases are available for mining (proprietary vendor lists, claims, registries, advocacy lists)?
- Are records in the databases consented for outreach, or is re‑consent required prior to contact?
- What match criteria should be used to surface qualified leads (ICD codes, medication history, procedure codes, lab values)?
- In what format and cadence should leads be delivered to sites (real-time portal, daily batch CSV, weekly report)?
- What minimum quality thresholds do you require for leads (e.g., phone verified, DOB match, recent encounter within X months)?
- Are there PII/PHI transfer restrictions or specific encryption/transfer methods required?
Build Trial Landing Page with Pre‑Screen Form
- Will landing pages be central trial pages or site-specific pages per catchment?
- What minimum form fields must be captured on the pre-screen form?
- Do you require embedded tracking pixels (Google, Meta) and UTM parameter capture?
- Who will host the landing page and manage SSL/compliance (vendor-hosted, sponsor-hosted, site-hosted)?
- Is an IRB‑approved consent or privacy notice required on the form prior to submitting contact information?
- Should the landing page be optimized for mobile-first traffic and ADA accessibility?
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Mutual Commit
Finalize commercial terms, launch timeline, data-sharing, regulatory responsibilities, and acceptance criteria for go/no-go.
Agreement Modules
- Non-Disclosure Agreement (NDA)
- Master Services Agreement (MSA)
- Statement of Work (SOW)
- Commercial Terms & Pricing Schedule
- Payment Schedule & Invoicing
- Data Processing & Data Sharing Agreement (DPA)
- Regulatory & IRB Responsibility Agreement
- Site Participation Addendum
- EHR Access & Screening Permissions
- Creative & IRB-Approved Materials Sign-off
- Tracking, Reporting & Analytics Integration Agreement
- Launch Timeline & Go/No-Go Acceptance Criteria
- Change Control & Scope Adjustment Agreement
- Termination, Data Return & Transition Plan
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Deployment
Operationalize rollout with readiness checks, enablement, and outcome validation.
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Pre-Deployment Readiness
Validate IRB approvals, site access, EHR screening permissions, creative sign-off, and call center resourcing for launch.
Readiness Questions
Start Here: A quick launch-readiness pulse
- How confident are you that this study is ready for an aggressive recruitment launch?
- What is the planned or target launch date we should build toward?
- Who will be our primary operational contact on your side for day-to-day launch decisions (name, role, best contact)?
- Which single 30-day outcome would make you call this launch an early success?
- Are there immovable governance or executive review dates we must align with?
If we flipped the switch tomorrow, what would break?
- If we launched tomorrow, what's the first thing you genuinely fear would derail progress?
- Which of these areas do you consider most fragile for launch?
- For each fragile area you selected, how long do you estimate remediation would take?
- Who on your team can make emergency decisions to keep launch on schedule (name/role), and how quickly can they respond?
- Have you experienced launch slips for similar reasons in the last 12 months? Tell us about one example and its root cause.
Rules, Red Lines, and Regulatory Reality
- What IRB or regulatory assumptions are you currently trusting that we should challenge before deployment?
- Is this study on a central IRB, local site IRBs, or a mix?
- Which specific materials still require IRB sign-off (e.g., ads, landing pages, call scripts, emails)?
- What is the typical IRB turnaround time at your sites (and please note any outliers)?
- Do any sites or the IRB require vendor pre-approval, redaction of vendor names, or specific language we must embed?
- Who is our IRB/regulatory liaison (name, role, preferred format for materials and feedback)?
Site Doors: Who Can Walk Through?
- Which site access assumptions are optimistic and likely to be challenged during deployment?
- What is the contracting status across participating sites?
- Do sites provide EHR screening or patient-identification access to external vendors today?
- Are there site-specific referral routing or patient-contact workflows we must mirror? Please describe key differences.
- List any site-level restrictions we must honor (contact hours, language, patient privacy rules, preferred communication channels).
- Which sites have a history of dropping referrals or slow handoffs, and what were the usual causes?
EHR Screening: Gates, Tokens, and Reality
- What assumptions about EHR access or query capability might be incorrect and need re-checking now?
- Which EHR systems are in use across your sites?
- Do we have formal EHR Data Use Agreements / BAAs in place for the sites where we'll screen patients?
- Are vendors authorized to run queries directly, or must sites run queries and share results?
- What PHI fields are required for pre-screening and are any of these restricted at specific sites?
- Once a request is submitted, how quickly can sites typically enable query access or share results?
Creative, Scripts, and What Patients Actually See
- Which parts of the creative or scripts do you expect the IRB or sites to push back on, based on past reviews?
- Which assets will require IRB approval?
- Do you have existing IRB-approved templates we must adapt, or do assets need to be created from scratch?
- Who must sign off on final creative and scripts (names/roles) and what is their typical review cadence?
- How many rounds of IRB/site revisions should we plan for on average?
- Will translations or cultural localization be required for patient-facing materials at any site?
People Power: Call Center, Staff, and Shiftwork
- What staffing gaps would leave our call center or referral routing overwhelmed in week one?
- Will the call center be vendor-operated, site-operated, or a hybrid model?
- What hours and timezones must the call center cover to meet patient and site expectations?
- What SLAs do your sites expect for referral handoffs (time to contact, time to pre-screen)?
- Which languages and interpreter support will be required at launch?
- Who will own escalations if a patient risks being lost between referral and site contact (name/role)?
Tech, Tracking, and the Conversion Signals That Matter
- Which tracking blind spots do you tolerate today that could mask an early launch problem?
- What systems must we integrate for tracking and reporting (select all that apply)?
- Do you have existing attribution/UTM rules or naming conventions we must follow?
- Which KPI thresholds should immediately trigger a go/no-go conversation or urgent remediation?
- Do you require API feeds for live data or are scheduled CSV uploads acceptable?
- Who should receive daily, weekly, and executive reports and in what formats?
When Things Go Wrong: Escalation, Decisions, and Go/No-Go
- What decision will you regret not having predefined if the launch shows early signs of failure?
- Do we have an agreed go/no-go acceptance criteria document for launch and initial performance?
- What commercial flex (budget reallocation, timeline extension, additional site support) is available if we need rapid remediation?
- Who has unilateral authority to pause or continue the campaign if an issue arises?
- How would you like us to surface and document lessons and remediation steps if we need to course-correct?
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Deployment Enablement
Schedule and execute campaign launches, activate referral routing, train site coordinators, and coordinate monitoring cadence.
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Validation Checklist
Verify tracking, conversion funnels, reporting feeds, and that initial conversion targets are met post-launch.
Validation Questions
Quick Snapshot — Tell Us Which Study We're Joining
- What is the study name / protocol number and a one-line summary of the indication?
- What phase is the trial currently in?
- What is the current randomization count versus target (numbers)?
- Which therapeutic area best describes this program?
- Who is our primary point of contact on your team for recruitment decisions (name / role)?
If the Trial Could Speak Honestly — Why Is It Behind?
- If you had to name the one truth everyone avoids saying about why enrollment is off-target, what would it be?
- Which sites are most behind and by roughly what percentage of their forecast?
- How much of the shortfall comes from feasibility over-estimates versus real screening barriers?
- How do you currently track the referral → pre-screen → consent → randomization funnel (tools or metrics)?
- Can you share an example of a recent referral that failed to convert and why?
Who’s Steering This Ship — Decision Roles & Pressures
- Who in your organization must sign off on changing recruitment tactics (titles/roles)?
- Which stakeholder is most likely to say 'no' to an aggressive recruitment change and why?
- What timeline do stakeholders expect for seeing early evidence that a new recruitment approach is working?
- Who on your side will be our day-to-day collaborator for site coordination and data exchange?
- How confident are you that internal decision roles and escalation paths are clear when a recruitment problem escalates?
What’s Really Hurting — The Part That Keeps You Up
- If enrollment doesn’t accelerate, what is the single worst program-level consequence you fear?
- Which eligibility criteria do sites and patients cite most often as blockers?
- How high is the local competition for your patient population at key sites (number of competing trials)?
- How do enrollment misses translate into program costs or timeline risk (qualitative or $ estimates)?
- How does this situation make you or your stakeholders feel — frustrated, powerless, pressured, or something else?
Let’s Challenge Assumptions — What If the Playbook Is Wrong?
- Which long-held assumption about your sites’ patient access might be false?
- How often do site feasibility estimates come with supporting EHR query data or just verbal assurances?
- What screening steps currently discard the most potentially eligible patients (and why)?
- Have you assumed that investigator enthusiasm equals referral volume? If yes, how has that assumption held up?
- What would have to be true about your patient population to consider shifting to more DTP or centralized recruitment?
Picture Success — What Would Real Improvement Look Like?
- If we achieved your ideal enrollment outcome in 90 days, what would we have changed (metrics and day-to-day)?
- Please provide target funnel KPIs (referral → pre-screen → consent → randomization) as percentages or numbers.
- What is an acceptable cost-per-randomized-patient for this program (or target range)?
- Which reporting cadence and formats would reassure leadership (dashboard, weekly digest, site-level scorecards)?
- What short-term wins would signal to you that a recruitment approach is worth scaling?
Operational Reality — What Must Change to Make Success Real?
- What single operational constraint would break any recruitment plan if we didn’t solve it first?
- Are IRB or central ethics approvals in place for recruitment materials and digital outreach?
- Do participating sites allow EHR screening and automated referral routing (and which EHRs)?
- What privacy or data transfer agreements (DTA / BAAs) will influence timelines?
- What call center / patient navigation resourcing is available at launch vs what you expect us to provide?
Proof Point — What Would Convince You to Move Forward?
- If you could ask us to deliver one measurable pilot in 30–60 days, what would that be?
- Which sites or geographies should we prioritize for a pilot (names or descriptors)?
- What acceptance criteria will you use to declare the pilot successful (example: X randomizations, Y% conversion, Z cost)?
- How soon can procurement/commercial terms be signed to enable a rapid start?
- Who needs to be on a weekly operational check-in during the pilot (roles/emails)?
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Success
Review enrollment outcomes, cost-per-randomized-patient versus targets, capture learnings, and maintain a shared channel for improvements.
Success Reviews
- Success Review — Enrollment Outcomes & CPA
- Site Performance Deep Dive
- Cost & ROI Review — Finance & Commercial
- Retrospective — Learnings & Playbook Updates
- Continuous Improvement Cadence & Handoff
Issues & Enhancements
- Publish a 'Lessons Learned' document with data attachments to the shared channel.
- Schedule site-specific retraining or operational support sessions.
- Adjust referral routing or caps for identified sites and notify stakeholders.
- Financial Summary & Reconciliation
- Validate financial accounting for the program and confirm CPA accuracy.
- Agree on any billing adjustments or commercial reconciliations.
- Identify cost optimization levers for future trials.
- Deliver reconciled financial workbook and detailed CPA supporting files.
- Implement any agreed billing credits or contract amendments.
- Create a per-channel unit cost library for future budgeting.
- Framing & Goals
- Document a prioritized list of lessons with evidence and recommended playbook updates.
- Assign owners and timelines to update SOPs, templates, and training materials.
- Create a test backlog to validate high-impact improvements in subsequent trials.
- Welcome & Objectives
- Update the recruitment playbook and site onboarding checklist based on decisions.
- Create an experiment/test plan with owners and success metrics for follow-up trials.
- Purpose of Ongoing Cadence
- Provision and structure a shared channel for all stakeholders to access results and artifacts.
- Agree dashboard KPI set and reporting cadence for ongoing monitoring.
- Assign monitoring and escalation owners and document the governance model.
- Confirm the onboarding checklist for transferring new studies into the cadence.
- Provision the agreed shared channel, upload final artifacts, and set permissions.
- Publish the agreed KPI dashboard and schedule automated reports.
- Create a governance RACI and distribute to stakeholders.
- Schedule the recurring performance review meetings and invite core participants.
- Confirm whether enrollment targets and acceptance criteria were met.
- Validate CPA calculation and explain variances to target.
- Assign owners for any immediate remediation or closure activities.
- Agree timeline for final sign-off and post-mortem deliverables.
- Produce consolidated final results and CPA report for sponsor sign-off.
- Assign owners and deadlines for all urgent remediation items identified.
- Publish meeting minutes and supporting datasets to the shared channel.
- Recap Site Targets & Commitments
- Identify root causes of underperformance at each flagged site.
- Agree site-level corrective actions with clear owners and timelines.
- Decide site continuation or reallocation of referral capacity.
- Ensure necessary site access or approvals are tracked and remediated.
- Create a site action tracker listing owners, actions, and due dates.
- Executive Summary of Outcomes
- CPA Calculation Walkthrough
- Top & Bottom Performers
- Shared Channel & Knowledge Repository
- Wins: Proven Tactics by Channel
- Funnel & Time-to-Randomization by Site
- Channel & Incrementality Analysis
- KPI Drilldown (Funnel & Channels)
- Failures & Root Cause Analysis
- Dashboard & Reporting Cadence
- Scenario Modeling & Optimization Opportunities
- Operational Barriers & Site Feedback
- Cost Review — CPA vs Target
- Playbook & Template Changes
- Roles, Responsibilities & Escalation Path
- Recurring Meeting Schedule & Governance
- Key Wins, Gaps & Risks
- Commercial Decisions & Adjustments
- Future Tests & Experiment Backlog
- Site Remediation Plans
- Decisions & Immediate Actions