Your research function, or an extension of the one you have.
We design and run studies for sponsors, from protocol development and IRB submissions through instruments, data capture, and operations at the sites until closeout. If you do not have a clinical team, we are it. If you do, we take on the studies or the pieces of them that your team does not have capacity for. We size the engagement to the program and we are accountable for the result.
You have the product and the question. You need the capacity to answer it.
Some sponsors are asked to produce clinical evidence before they have a clinical department. Others have the department but more studies than it can run. Either way, the usual options are the same. You can hire ahead of need, you can split the work across several vendors and manage the hand-offs yourself, or you can engage a large CRO and accept the overhead that comes with it.
We offer a fourth option: one accountable team that does the work a research function does, from the protocol to the closeout report, and that scales with the program rather than ahead of it.
We are currently supporting active trials with early-stage sponsors.
We work as part of your team
Embedded
We sit in your meetings, work in your tools, and take part in your decisions. You get one accountable lead and direct access to the people doing the work, not an account manager in between.
Right-sized
Scope follows the program. It can be a single protocol, a full study, or ongoing support across several, and it can change as you raise money, hire, or change direction.
Accountable
Your agreement is with us. We manage quality, review every deliverable before it goes out, and remain responsible for the result through closeout.
From study concept to closeout
Four functions, delivered by one team. Engage all of them or only the ones you are missing. In either case the work product is yours.
Study design and protocol development
We turn a product and a research question into a protocol that can be reviewed, approved, and executed. That covers objectives and endpoints, design, eligibility, procedures, the schedule of assessments, safety reporting, and statistical considerations, along with the informed consent form and the supporting documents reviewers expect to see.
Regulatory strategy and submissions
We work out which pathway applies to your product and study and what the reviewing bodies will expect, then we prepare and submit the packages. That includes IRB submissions and correspondence, registrations, risk determinations, and the ongoing compliance work for the life of the study.
Instruments and data-capture design
We select or design the instruments the protocol calls for, such as questionnaires, outcome measures, and case report forms, then build and validate the data capture system around them and write the data management plan. The goal is that what gets collected is what the analysis will need.
Study operations through closeout
Site selection and start-up, training, monitoring, safety reporting, trial master file and document control, data cleaning, database lock, and closeout reporting. This is the day-to-day management that keeps a study on protocol and on schedule.
What working with us looks like
Scope
We map what you have, what is missing, and what the study needs to show. Then we put a written scope, timeline, and deliverables list in your hands, in a form you can share with your board or your investors.
Build
The protocol, consent, submissions, instruments, and data systems are developed in parallel, and a senior lead reviews each one before it goes to an IRB or a site.
Run
We operate the study day to day, including the sites, monitoring, safety, and documents, and we report to you on a fixed schedule so you always know where things stand.
Close
You get clean data, complete documentation, and a closeout package that is ready for the analysis, the submission, or the next study.
Built to run at real sites
A protocol is only as good as a site's ability to execute it.
We build research infrastructure for hospitals and clinics as well as studies for sponsors, so we know how research staff actually work. The protocols we write, the forms we design, and the operational plans we put together take that into account: what a coordinator can realistically collect, what an IRB will question, and what a monitor will look for.
What you can hold us to
- One accountable lead per engagement.The person you scope with owns the work through closeout.
- No hand-offs to people you have not met.The team that designs the study is the team that runs it.
- You own the protocol, the data, and the documents.Everything we produce is delivered in a form you can take anywhere.
- Built to stand up to review.Every document is written on the assumption that an IRB, a monitor, or an inspector will read it, because one will.
- We turn down work we cannot do well.If we are not the right team for the study, we will tell you in the first conversation.
Who we work with
We work with sponsors of any size that need clinical or human subjects evidence. That includes emerging companies running their first studies and established sponsors whose clinical teams need more studies designed and run without adding headcount. Engagements range from a single protocol or submission to full execution of a study from design through closeout.
Common questions
When should we bring you in?
Do you replace a CRO or work alongside one?
Who handles the IRB?
Who owns the data and the documents?
What do you need from us to start?
Tell us about the study you need to run.
A short call is usually enough for us to tell you whether we are the right team and what a first scope would look like.