Whether you need strategic advice, ongoing leadership, or support on specific tasks, we tailor our approach to your needs.
How we advise
Every engagement starts with understanding your goals. We then review what you already have, including existing work, capacity, and assets, and your constraints, such as timelines and budget. From there, we help you find the gaps, whether you've spotted some or aren't sure where to begin. We lay out options, weigh their trade-offs, and recommend one. The final choice is yours.
Strategic consulting
An independent expert to help you explore your options
Is this for you?
- You have ideas and want to think them through before committing resources.
- You've completed a study, found interesting or unexpected patterns in your data, and are deciding where to go next.
- You've made substantial progress, in house, with CROs, or through other means, and need an independent assessment of where you stand and how to proceed.
- You're thinking ahead and want a plan: what to prepare, whom to engage, and when, so you're ready when an opportunity arises.
We help you think through the big questions before your next major commitment, from assessing existing work to shaping a new study or direction. We outline your main options, weigh their rigor, feasibility, and regulatory implications, and sketch what each would take in time, cost, and resources. When you're ready to execute, our other services can take it from there.
Fractional statistical leadership
Embedded in your team, invested in your success
Is this for you?
Your organization needs statistical leadership, but not a full-time hire. This is especially valuable when:
- you're building a program and want to plan strategically from the start, knowing your needs will rise and fall over time;
- your program spans multiple studies or vendors, and the work needs to stay aligned and consistent;
- you're preparing for a major milestone, such as a regulatory submission, and need your statistical work organized into a coherent package; or
- you want to build in-house capacity and need guidance on what to develop internally and how to structure it.
We serve as your strategic statistical partner, inside your organization and at the leadership table, at a fraction of the cost. We stand by your side at critical junctures and remain a resource until your needs are met. This includes:
- Planning: an efficient statistical and data pipeline, informed by historical data, with contingencies for the unexpected.
- Oversight: vetting and coordinating vendors to eliminate redundancy and keep standards consistent.
- Readiness: organizing your statistical work into a coherent package for milestones such as a regulatory submission.
- Capacity: deciding what to build in house, training your team, and structuring internal functions.
Task-oriented services
Expert execution for specific statistical needs
Is this for you?
You know what you need, but lack the in-house expertise or capacity to deliver it. That may be routine support, such as writing or reviewing a protocol, analysis plan, manuscript, or submission package, or an independent statistician for a Data Safety Monitoring Board. Or it may be a more complex challenge, such as:
- new ground you're breaking, like a rare or poorly understood disease in an unstudied population, that calls for a novel endpoint or study design built on the most rigorous approach;
- an unexpected problem during study conduct, such as higher-than-expected missing data in certain arms or inconsistent measurements, that needs a proactive fix before it compromises the study;
- novel patterns that were observed after the study ended, presenting opportunities you want to explore with rigorous follow-up analyses; or
- complex data, such as omics, imaging, or patient-reported outcomes, where standard methods fall short and more advanced approaches are needed.
When you know the gap, we fill it with focused, rigorous work, from routine support to specialized methods. Each task is scoped up front, with clear deliverables and timelines.
Developing new methods
Research-driven solutions when no off-the-shelf method exists
Our principals are active methodological researchers. When no existing approach fits your question, we develop one, and when a problem lies beyond our expertise, we bring in leading academic collaborators and work alongside them. Where appropriate, this work can lead to joint publications that strengthen your program's scientific foundation.
We are not a CRO
CROs play an essential role. Their scale, built-in systems, and audit-ready processes make them well suited to routine studies and large pharmaceutical sponsors with established and diverse portfolios. For smaller organizations, the same scale can be a poor fit. Large infrastructure brings high overhead, staff turnover can disrupt continuity, work is often rebuilt from scratch for each study, and clients may have limited visibility into how decisions are made.
Lean organizations face tight budgets, greater ambiguity, and higher stakes, with trajectories that can shift quickly. AI adds both opportunity and risk: it can accelerate routine statistical work, including programming, one of the core functions of traditional CROs, but without expert direction its output can be irrelevant or inefficient, and correcting course later can cost more than the time saved. Such organizations need an agile, transparent, and forward-looking statistical partner who respects each organization's vision, strives to understand its program, carries knowledge from one study to the next, and adapts as plans change.
AI is not a panacea but one resource among many. Using it well takes more than strong programming: it takes someone who understands the complexity of your data and the principles of statistical inference, and who can tie the evidence back to the science. That is what strategic consulting and fractional statistical leadership provide. Drawing on experience in house and with outside vendors, we help you choose the right tools for each task, AI included, and make sure the results answer the questions that matter.