When Google, AI, or another SOP isn't enough
Bring the problem. We'll work on the decision behind it.
Clinical operations leaders have more information available to them than ever. The harder problem is often determining what the information means for this trial, this team, this vendor, this decision - right now.
ASK LEILA™ is not a paid search engine and it isn't a generic advice call. It is 45 minutes of focused access to an experienced executive-level clinical operations operator who has worked in and lived through the daily sponsor- and CRO-side operational realities of global trials, CRO and vendor relationships, sites, timelines, budgets, escalations, study recovery, and organizational change.
ASK LEILA™ | Clinical Operations Decision Support
A private 45-minute Clinical Operations Decision Session with Leila Cupersmith
Frequently Asked Questions
Please reach us at Leila@ChoiceClinOps.com if you cannot find an answer to your question.
ASK LEILA™ is a private 45-minute Clinical Operations Decision Session with Leila Cupersmith for professionals and sponsor leaders facing a specific clinical trial operations problem, decision, or execution challenge. The session is designed to help separate the underlying issue from the surrounding noise and identify practical next actions.
I have spent my career inside the operational realities inside clinical trials—not simply advising teams from outside them.
My experience spans clinical operations roles from study-level execution through senior global oncology leadership, across FIH, Phase I–III programs and more than 30 countries. I have worked across oncology, rare disease, and cell and gene therapy programs; managed global studies and CRO/vendor relationships; worked with budgets ranging from approximately $8 million to $137 million; designed supported clinical study programs through organizational and portfolio transitions; and contributed to 5 clinical development programs that ultimately brought therapeutics to market.
My work has included accelerating site activation, removing weeks from first-patient-in timelines, reducing protocol deviations, identifying substantial vendor savings, accelerating database lock, rescuing more than 50 clinical trials, and helping teams recover when execution was not progressing as planned.
That breadth matters because clinical operations problems rarely exist in isolation. A “site problem” may actually be a feasibility, vendor-management, protocol, resourcing, escalation, or sponsor-governance problem. A “CRO problem” may partly be a decision-rights problem inside the sponsor. A slipping timeline may be the visible symptom of something that happened months earlier.
ASK LEILA™ gives you access to that pattern recognition for one focused decision—without requiring your company to begin a larger Choice ClinOps engagement.
AI can explain clinical operations concepts, generate options, summarize regulations, and help you think through a problem. ASK LEILA™ is for situations where general information alone is not enough.
You are paying for access to an experienced, executive-level clinical operations operator who can listen to the specifics of your situation, ask the questions you may not know to ask, challenge assumptions, recognize operational patterns and downstream consequences, and help you determine what deserves your attention before you make the next decision.
My hands-on experience spans FIH through Phase III clinical development across global oncology, rare disease, and cell and gene therapy programs. I have worked in sponsor and CRO environments ranging from boutique organizations to some of the world's largest, across 34 countries, with study budgets from $8 million to $137 million, and on clinical development programs that contributed to five therapeutics reaching the market.
That experience has required me to work through the realities behind clinical trial execution: CRO and vendor governance, study design and operationalization, budget development and management, complex study recovery, site identification and performance, damaged site relationships, data-system builds, regulatory changes, supply constraints, timeline pressure, global execution, and organizational transitions—while keeping high-profile clinical trials moving.
During ASK LEILA™, I am not simply answering the questions you bring me. We are working the problem together. I am helping you determine whether you are asking the right questions, focusing on the right problem, involving the right stakeholders, recognizing the relevant risks and downstream consequences, and ultimately preparing to take action from a more informed position.
The goal of the 45 minutes is to leave you with greater clarity about the decision in front of you, the risks and tradeoffs that matter, the questions that still need answers, and practical next actions you can take.
AI can give you information. ASK LEILA™ gives you human judgment—grounded in lived, hands-on clinical trial experience—applied to your specific situation.
They serve two different purposes.
A Choice ClinOps Exploratory Meeting is a brief, complimentary business conversation for a sponsor or organization considering engaging Choice ClinOps. Its purpose is to understand the organization's potential need, determine whether Choice ClinOps' sponsor-side Clinical Operations services may be a fit, and decide whether it makes sense to explore a formal engagement. It is not intended to diagnose or work through a specific Clinical Operations problem.
ASK LEILA™ is a paid, 45-minute working session focused on your specific Clinical Operations problem, challenge, or decision. You do not need to be considering a Choice ClinOps engagement.
Before an ASK LEILA™ session, I review the intake you provide so we can spend our time working the problem rather than establishing basic context. During the session, we examine the situation, challenge assumptions, identify missing questions or stakeholders, consider operational risks and downstream consequences, and determine practical next actions. You also receive a written Decision Summary following the session.
Choose an Exploratory Meeting when you are considering hiring Choice ClinOps.
Choose ASK LEILA™ when you want Leila's experience and judgment applied to a specific problem or decision.
If an ASK LEILA™ session reveals that your situation requires sustained operational ownership rather than a single decision session, we can separately discuss whether Choice ClinOps is an appropriate fit. There is no obligation to do so.
Sometimes a trusted colleague is exactly what you need. ASK LEILA™ is useful when you want a confidential, independent perspective from someone who is not inside your reporting structure, organizational dynamics, CRO relationship, or need an immediate decision.
I don't need to defend the existing plan, protect a vendor relationship, support a previous decision, or navigate internal politics. My role during the session is to understand the operational problem in front of you, pressure-test the assumptions around it, and help you see the available decisions and consequences more clearly.
You are not paying for agreement. You are paying for an experienced, independent second set of eyes.
Topics may include CRO performance and oversight, vendor challenges, site performance, trial execution, enrollment and timeline pressure, escalation decisions, sponsor oversight, budget visibility, global execution, leadership challenges, clinical operations continuity pre-, during, or post-M&A or CRO transition, clinical operations career decisions, change management, or risk management.
Your session includes a pre-session intake, a private 45-minute Decision Session focused on one primary issue, and a concise written Decision Summary delivered within one business day outlining key considerations, questions, and practical next actions.
ASK LEILA is designed for Clinical Operations professionals and leaders—including CTMs, Directors, Senior Directors, Heads/VPs of Clinical Operations, biotech executives, site/research leaders, and independent clinical research professionals—who would benefit from an experienced second perspective on a specific decision or challenge.
No. ASK LEILA is a focused Decision Session rather than an ongoing engagement. When a situation requires sustained sponsor-side ownership, governance, vendor management, study rescue, or execution, that work can be separately scoped through Choice ClinOps.
After payment, you'll be directed to a short confidential intake. Once you submit it, you'll select your 45-minute session time. Your appointment confirmation and meeting information will then be sent automatically.
Come prepared to focus on one primary Clinical Operations issue, challenge, or decision. After payment, you will complete a short confidential intake describing the issue you would like to address and the outcome you hope to achieve. This allows Leila to review the context before your session so your 45 minutes can focus on the decision itself rather than background gathering.
Do not submit Protected Health Information (PHI), patient-identifiable information, confidential third-party information, confidential information - not available to the public - trade secrets, or information you are not authorized to disclose. Situations should be described with only the operational context necessary for the discussion.
If additional discrete decisions would benefit from focused sessions, a three-session ASK LEILA package is available for $995. Situations requiring ongoing operational ownership or execution may be better suited to a separately scoped Choice ClinOps engagement.