A study that fails at design fails expensively
Every study has a set of assumptions that have to hold. Testing them costs weeks. Discovering they do not hold, after analysis, costs the programme.
We take a single question and establish whether the data supports it: can the cohort be identified, is the outcome captured, is the denominator right, is the follow-up long enough, and what sample would you actually get. In writing, before money moves.
Every study has a set of assumptions that have to hold. Testing them costs weeks. Discovering they do not hold, after analysis, costs the programme.
The most common quiet failure in real-world evidence is a cohort that turns out to be a tenth of the expected size. This finds that in week two.
Most questions arrive as a sentence. What a study needs is a cohort definition, an index date, an outcome definition and a comparator. Producing those is the work.
And that is the finding you are paying for. A clean no in week three is worth more than a compromised yes in month six.
We take a single question and establish whether the data supports it: can the cohort be identified, is the outcome captured, is the denominator right, is the follow-up long enough, and what sample would you actually get.
Named, dated and agreed at scoping. Every one of these is a thing you can hold, circulate internally and be held to, not a description of an activity.
Is the question answerable, in which market, from which data type, and how fast. One page at the front, the reasoning behind it.
Inclusion and exclusion criteria, index date definition, follow-up window and comparator, written so it can be executed by an analyst who was not in the room.
With the assumptions that drive it stated explicitly, so you can see what would make the number move.
Whether each endpoint you want is actually captured in the source, at what completeness, and what has to be inferred rather than observed.
Written at the start rather than discovered in review. A limitation you predicted is a caveat; one you did not is a finding against you.
And where the answer is redesign, the specific change that would make the question answerable.
We turn a sentence into a testable specification. This is the step clients most often underestimate and most often thank us for.
We check cohort identifiability, outcome capture, denominator validity and follow-up length against the actual data structure.
An expected sample with its assumptions exposed, including the subgroups you will want later.
A written feasibility view with a clear verdict, and a working session to go through it.
Alongside every engagement: weekly updates, methodology agreed before work starts, quality control at every phase, interim reporting rather than a single reveal, and milestones you accept rather than discover.
The cohort specification becomes the analysis specification. No redefinition, no drift, no argument about what was agreed.
Describe the decision you are trying to make. If a cheaper offering answers it, we will tell you that instead.