Pharma · Discovery Call
Discovery Call Questions for Pharma: A 25-Minute Diagnosis with Clinical Ops and Medical Affairs
You have twenty-five minutes with a VP, Clinical Operations whose Gantt says FPI was in March, whose CTMS says 40% of sites aren't green-lit yet, and who has already sat through four vendor calls this quarter that opened with a logo slide. She booked you anyway. That means she thinks you might know something about randomizations per site per month that her CRO's weekly enrollment call isn't telling her. Open with credentials and you've confirmed you don't.
Pharma discovery is layered in a very particular way. The symptom arrives free in the first ninety seconds — "we're behind the curve." The mechanism is one honest follow-up down: the site contract sat in legal at an academic center for 71 days, the IRB cycle ate another six weeks, and the coordinator who finally got green-lit is running eleven other studies and yours isn't her priority. The cost lives another layer below that, and half the time your buyer genuinely can't say it out loud — the study is blinded, they're pre-readout, or the company is in a quiet period. The stake is the bottom layer and it's rarely operational: someone told a board that topline lands before the next financing window, and the protocol amendment being drafted right now to loosen I/E is the sound of that promise being renegotiated.
This playbook gives you the clock, the question set, the thirty-second answer to "so what do you actually do," and the objections you will hear from Clinical Development, Patient Recruitment, Medical Affairs and Launch Readiness buyers — CRO scope, MLR queue, site adoption, vendor qualification. Every question is written to be said out loud. Nothing here needs a deck.
The discovery call script
Say it in your own words. The structure is the part that matters.
- 1
0:00–2:00 — The Frame (do not re-pitch)
"Thanks for clearing the time. When we traded emails you said the Phase III is tracking behind the enrollment curve and you're looking at an amendment to the I/E — that's the thing I want to understand, not talk at you about. Fair warning on how I run these: I'm going to ask questions for most of the twenty-five minutes. I'd genuinely rather tell you at minute twenty that this isn't a fit than burn a slot showing you slides. Nothing I show you is worth anything until I know whether your problem is site activation, screening yield, or referral volume — because those are three different fixes. Still good for twenty-five? And is there anything you want to make sure we get to, so I don't run us out of time?"
- 2
2:00–6:00 — Layer 1 to Layer 2: how enrollment actually runs
Pick ONE opener. Then follow up three times before changing threads. • "Walk me through how a patient gets into this study today — from where the site first hears about them to randomization." • "When you said you're behind the curve — what does the enrollment plot actually look like against the forecast right now?" • "What changed that made this something you're working on this quarter rather than last?" Mechanism follow-ups (these are the ones that earn layer three): • "Take me through the last site that green-lit late. What actually held it up — budget and contract, IRB, the PSSV, or regulatory packet?" • "Of the sites that are activated, how many have randomized zero? What do you hear from those PIs on the monthly call?" • "Who's doing the pre-screening today — the coordinator running a chart pull, or is the CRO's site management team feeding referrals in?" • "Where does that sit between the CTMS and what the CRA actually sees on a monitoring visit?" • "What's the workaround your CRAs have built to keep the low enrollers moving?"
- 3
6:00 — The minute-six trap: "So what do you guys actually do?"
Thirty seconds, tied to what they just said, then hand the ball straight back. "Short version — we find and pre-qualify patients against your actual I/E criteria before they ever reach the site, so the coordinator gets a referral with the eligibility boxes already checked instead of a name and a phone number. No site login, nothing for her to learn. But I'd be guessing at whether that matters to you until I understand one more thing — of the patients who do get consented, where are you losing them? Eligibility, washout, or labs?" If they push a second time, give a clean sixty seconds, then: "Can I go back to the thing you said about the two sites in the Southeast that have randomized zero? That's the part I'm not clear on." They will let you.
- 4
11:00–16:00 — Layer 3: the cost, then the second beat
Never accept the first number. Always ask how they know it. • "What's your randomizations per site per month right now against what was forecast in the bid defense?" • "And what's the screen failure rate looking like — is it flat across sites or is it concentrated in a handful?" • "How do you know? Is that coming out of the EDC or out of the CRO's weekly deck?" • "What's your site activation cycle time, contract to green-light, in days? Where's the median sitting versus what you planned?" • "What's cost per randomized patient on this study, roughly — and does that include the change orders?" • "What's the monthly burn while the study runs? So a three-month slip is what, in run-rate?" If they can't answer: that's a finding, not a failure. "That's useful — if nobody can tell you the screen failure rate by criterion, then nobody can tell you which arm of the funnel to fix either. Who would have to pull that?"
- 5
16:00 (or wherever cost lands) — Layer 4: the stake, then shut up
• "Who's feeling this most right now — you, the Chief Medical Officer, or the program lead?" • "What did the team commit to for topline? Was that a board commitment or an internal date?" • "If the readout moves a quarter, what moves with it?" • "Who's sponsoring the amendment internally, and what happens to your timeline if the IRB cycle runs long on it?" • "If this study is in exactly the same position in six months, what's the conversation you're having, and with whom?" Then count to three. Do not fill the gap. The sentence after the pause — "honestly, the financing story depends on this" — is the one that funds the deal.
- 6
16:00–20:00 — Qualify the path (never as a checklist)
• "If you decided this was worth doing, what actually happens next in your shop? Does it go to procurement, or does clinical finance fund it out of the study budget?" • "Who else gets pulled in — privacy, IT security, the GxP assessment, vendor qualification? In what order?" • "Where does the CRO sit in that? Are they scoped for recruitment, and is this a change order or a sponsor-direct vendor add?" • "Have you tried to fix this before? What happened with that vendor?" — the graveyard of the last failed recruitment vendor is your real competition. • "What's forcing the timing — the amendment, the DSMB interim, a board date?" • "Is this a line item that already exists on the study budget, or would it have to be created?" • "And if you do nothing — you run the amendment and hope the loosened I/E fixes it — where do you land?"
- 7
20:00–23:00 — Targeted relevance (90 seconds, only what they raised)
"Two things from what you described, and then I want to land a next step. On the washout screen failures — we build the pre-screen off your actual exclusion criteria, including prior-therapy washout, before anyone gets referred. So the site isn't consenting people who were never going to randomize. And we contract on randomized patients, not referrals, which means the screen failure risk sits with us, not with your study budget. On the CRO — we don't replace them. We've been added as a sponsor-direct vendor on studies where the CRO was relieved, because they were the ones taking the escalation call about the eight zero-enrolling sites. That's it. I'm not going to walk you through a platform today."
- 8
23:00–25:00 — Playback and a dated next step
Playback in their words: "Let me make sure I've got it. You're four months behind the curve, and the reason is two-part — activation is running past 100 days at the academic sites because of contracting, and the sites that are open are screen-failing on washout and eGFR at a rate nobody's broken down by criterion. It's roughly $6M a month in run-rate, and the CMO has told the board topline before the financing window. Did I miss anything, or get anything wrong?" Then prescribe: "Based on that, the useful next thing isn't a demo. It's forty-five minutes with you, your Head of Patient Recruitment and whoever owns the feasibility list — where we take your actual I/E criteria and model where the eligible patients sit against your current site footprint. Bring the site list and the screen failure breakdown if you can get it. I've got Tuesday at 2 Eastern or Thursday morning. Which works?" Then: "And separately — send me your vendor security questionnaire and DPA template today. I'll return the completed pack with SOC 2 and the Part 11 documentation this week so privacy's clock starts running in parallel, whatever you decide." Invite out before you hang up.
- 9
What goes in the CRM
Their words, verbatim. "40% of sites not green-lit, median contract-to-activation 71 days at academics, eight activated sites at zero randomizations, screen failures concentrated on prior-biologic washout, burn ~$6M/month, CMO committed topline to board pre-financing, amendment being drafted to loosen I/E — she called it 'the expensive way to fix this.'" Not: "prospect has enrollment challenges." The first version writes your business case, your follow-up email and the exec summary. The second version writes nothing.
How the call actually sounds
Prospect on the left, the rep on the right.
Rep
Thanks for the time. You mentioned in your reply that the Phase III is behind the curve and the team's drafting an amendment to loosen I/E. That's what I want to understand. I'm going to ask a lot of questions and show you nothing — walk me through how a patient actually gets into this study today, start to finish.
Buyer
Standard. Sites identify from their own patient population, coordinator pre-screens, PI confirms eligibility, consent, screening visit, randomize. We're behind, yes. 40% of sites aren't green-lit and a chunk of the ones that are haven't randomized anyone. But before you go further — recruitment is in the CRO's scope of work. That's their line item, not mine.
Rep
Understood, and I'm not trying to take it off them. Take me through the last site that green-lit late — what actually held it up? Budget and contract, IRB, the site initiation visit?
Buyer
Honestly that's a question for my CRO's project manager. I'd have to pull the CTMS report.
Rep
Fair. Different angle then — what was the last escalation call about? The one that got put on your calendar with no agenda.
Buyer
…Two academic centers in the Northeast. Contract negotiation on indirects dragged nine, ten weeks, then the IRB cycle, then the coordinator who was going to run it went on leave and the site management org gave us someone covering eleven other studies. Our protocol is number nine on her list. So yes — activation cycle time at the academics is somewhere north of a hundred days and I don't love it.
Rep
That's the part that doesn't show up on the weekly deck. And on the sites that are open — what's randomizations per site per month running at against what the CRO forecast in the bid defense?
Buyer
I'm not going to give you that. We're blinded and we're in a quiet period ahead of an interim. I can't be handing enrollment metrics to a vendor on a first call.
Rep
Completely reasonable — don't give me a number. Give me a direction. The forecast was, what, one and a half a month per site? Are you at roughly half of that, or closer to a third?
Buyer
Closer to a third across the board. And the screen failure rate is the thing that actually keeps me up — it's high, and it's not evenly distributed. Some sites are screening five to randomize one.
Rep
Where are they failing? Eligibility on the primary criterion, washout from prior therapy, or lab values?
Buyer
Mostly washout on prior biologic exposure, some eGFR. We think. Nobody's given me a clean breakdown by criterion.
Rep
How would you know if they had? Is that coming out of the EDC, or is it the CRO's slide?
Buyer
It's the CRO's slide. Which is part of the problem, because they're also the ones I'd be asking to explain why the number's bad.
Rep
So the amendment to loosen I/E is the fix on the table. What does that actually cost you in time — re-consent, IRB cycle, the whole thing?
Buyer
Three months, realistically, and it's the expensive way to solve this. Our burn is roughly six million a month. And if the readout moves past the board meeting, the financing conversation changes, which is not a sentence I want to be the author of. Our CMO has already said topline lands before that window.
Rep
…
Buyer
Look, I'll be straight with you. We used a recruitment vendor on the last study. They sent volume, we paid per referral, and better than half were screen failures — the site absorbed the screening cost and my PIs are still annoyed about it. So whatever you're about to propose, that's the room you're walking into.
Rep
That's the right thing to be angry about — you paid for volume and ate the screening cost. Two things and then I'll stop. We contract on randomized patients, not referrals, so if someone screen-fails on a criterion we should have caught, that's our cost. And the pre-screen gets built off your actual I/E, washout included, so the coordinator running eleven studies gets a referral with the boxes already checked. No login, no new SOP for her.
Buyer
If it touches physicians in any way it goes to MLR and that's six to twelve weeks and three review rounds, minimum. And privacy and IT security will take four months on a new vendor. I'm not being obstructive, I'm telling you what saying yes costs me personally.
Rep
Then let's not put anything in the MLR queue yet. Most of what we do sits pre-consent and never touches a promotional asset — the first conversation is a process description with your MLR lead, not content. On privacy: send me your security questionnaire and DPA template today and I'll return the completed pack, SOC 2, HIPAA and GDPR positions and Part 11 documentation this week. That clock runs in parallel and costs you nothing while you decide whether this is even worth doing.
Buyer
That I can do. The questionnaire comes from vendor qualification, I'll get it routed.
Rep
Then here's what I'd propose. Forty-five minutes with you, your Head of Patient Recruitment, and whoever owns feasibility — we take your actual I/E criteria and model where eligible patients sit against your current site footprint, so you can see whether the amendment is the only lever. Bring the site list and whatever screen failure breakdown you can get. Tuesday at 2 Eastern, or Thursday morning?
Buyer
Thursday. And bring the randomized-patient contracting model in writing — my clinical finance lead will ask, and I'd rather not be the one explaining it.
Rep
Thursday at 9, forty-five minutes, you plus recruitment plus feasibility, and I'll send the contracting model and the security pack ahead of it. Invite's going out before I hang up.
Objections you will hear
What they say, and what you say back.
| Objection | How to answer it |
|---|---|
| “Our CRO owns recruitment. That's in their scope of work.” | It usually is, and it's usually the line item they're behind on. What's your actual randomizations per site per month against what they forecast in the bid defense? If it's under, the change order to fix it costs you more than a parallel channel would. We're not replacing them — we work alongside the CRO, and we've been added as a sponsor-direct vendor on studies where the CRO welcomed it, because they were the ones taking the escalation calls about the zero-enrolling sites. |
| “Anything touching HCP engagement has to clear med-legal — that's months.” | Understood, and I'd rather you didn't put it in the queue yet. What I'd propose first is a scoping conversation with your MLR lead and privacy on the process only — no content, no promotional claim, nothing branded. Most of what we do sits pre-consent and never touches a promotional asset. If we define what actually needs review, you're submitting a two-page process description instead of a full campaign, and I've seen that clear in one cycle instead of three. |
| “Sites won't adopt another platform. Our coordinators are drowning.” | Agreed, and if it needs a coordinator login it fails — I'd tell you not to buy it. The pre-screening happens on our side. The site receives a pre-qualified referral with the I/E boxes already checked and the consent conversation teed up. Her workload goes down, not up. Ask the one site you've got a genuinely good relationship with what they'd say to that, and let their answer decide it. |
| “We tried a recruitment vendor on the last study. Half the referrals were screen failures.” | That's the right thing to be angry about — you paid for volume and absorbed the screening cost at the site. What was the screen failure rate, and where did they fail: eligibility, washout, or lab values? We contract on randomized patients, not referrals, and the pre-screen gets built off your actual I/E. If we send someone who screen-fails on a criterion we should have caught, that's on us, not your study budget. |
| “Privacy, IT security and the GxP assessment will take four months to clear you.” | They will if we start cold. Send me your vendor security questionnaire and DPA template now — we have the completed pack, SOC 2, our HIPAA and GDPR positions and the Part 11 documentation ready to go. That work happens in parallel while your team decides whether this is even worth doing. It costs you nothing to start the clock, and it means you're not the person who found the solution and then waited a quarter for qualification. |
| “This budget was set last year. There's no line for it.” | Where does a month of trial delay get charged? Most groups I work with fund this out of the study budget as a rescue line, or out of change-order money that would otherwise go to the CRO. If your burn is six million a month and this pulls LPI in by six weeks, that's a redirection, not a new ask. Who actually owns that study-level budget — you, or clinical finance? |
| “We're mid-readout. Nobody signs anything new this quarter.” | Then this isn't a signature conversation. When does your next protocol start enrolling — Q3? The sites you'll need are being selected right now and feasibility takes ninety days regardless. Give me thirty minutes with your ops lead to map the site list for that study, so the day the readout clears you're not starting from a blank feasibility questionnaire. |
Questions reps ask about this call
- What are the best discovery call questions for pharma clinical operations buyers?
Start with process, not pain: "Walk me through how a patient gets into this study today, from identification to randomization." Then follow up three times on the same thread before moving on. The highest-yield follow-ups are "take me through the last site that green-lit late — what held it up, contracting or IRB?", "of your activated sites, how many have randomized zero?", and "where are the screen failures concentrated — eligibility, washout, or labs?" These get you to mechanism. Cost questions come after: randomizations per site per month versus forecast, site activation cycle time in days, and cost per randomized patient — each followed immediately by "how do you know?"
- How do I run discovery when the buyer says they can't share enrollment data because the study is blinded?
Don't push for the number, ask for the direction. "Don't give me the figure — the forecast was one and a half randomizations per site per month, are you at half of that or a third?" Directional answers are not unblinding and most VPs of Clinical Operations will give them. You can also ask about things that aren't blinded at all: site activation cycle time, how many sites are green-lit versus contracted, median days in contracting at academic centers, and whether the screen failure breakdown by criterion exists anywhere. If it doesn't exist, that's a finding worth more than the number.
- How do I qualify a pharma deal without asking about budget and authority in the first ten minutes?
Ask about the path instead of the person. "If you decided this was worth doing, what actually happens next in your shop — procurement, or does clinical finance fund it out of the study budget?" and "who gets pulled in, and in what order — privacy, IT security, GxP assessment, vendor qualification?" In pharma the answer is a sequence, not a name, and the sequence tells you the real timeline. Then ask the sizing question rather than the budget question: "Is this a line item that already exists on the study budget, or would it need to be created?"
- The buyer says the CRO owns recruitment. Is the call over?
No — it's the start of layer two. The right response is a question, not a rebuttal: "What's the randomization rate per site per month against what they forecast in the bid defense?" If the CRO is behind, your buyer is already having escalation calls about it and the change order to fix it is expensive. Position as sponsor-direct and parallel, never as replacement. Sponsors who are unhappy with CRO recruitment performance will rarely say so on a first call, so listen for softer signals: "that's the CRO's slide," "I'd have to pull the CTMS report," "they gave us someone covering eleven studies."
- How do I keep MLR from killing the deal before it starts?
Get in front of it in discovery rather than defending against it later. Ask "what's your MLR cycle time right now — days, and how many review rounds per asset?" It signals you know the constraint. Then take the queue off the table for now: propose a process-only scoping conversation with their MLR lead and privacy, with no content and no promotional claim. Anything that sits pre-consent and never touches a branded asset often needs a two-page process description instead of a full submission. If your product does touch HCP-facing material, say so plainly on the discovery call — pharma buyers punish surprises at contracting far harder than they punish honesty at minute fifteen.
- What's a strong next step to close a pharma discovery call?
Never "I'll send some information." Prescribe something that produces an artifact they need anyway: forty-five minutes with them, their Head of Patient Recruitment & Site Engagement and whoever owns feasibility, to model where eligible patients sit against their current site footprint using their actual I/E criteria. Name a date, name the attendees, name what they should bring — the site list and the screen failure breakdown. In parallel, ask for the vendor security questionnaire and DPA template on the call so privacy and IT security start running while the evaluation happens. That single request often saves a quarter.