In complex clinical trials, the gray zone isn't solved by process or platform. It's solved by the same expert understanding your data across every layer of your study. From protocol design through FDA submission, we deliver the judgment to see what your data actually says, and to make it stand up.
What we hear from sponsors, in their words or close to it.
"We're finalizing the SAP, and we only get one shot at this readout."
Statistical Consulting
"Our budget funds a trial smaller than our power calculation wants."
Study Design
"We'll deal with the odd values when we unblind."
Biostatistics
"Nobody has traced this data end to end, and we have an audit coming."
Clinical Programming
"Site 14's data looks too good."
Fraud Detection
"The biomarker moved. The clinical endpoint hasn't, yet."
Biostatistics
"Topline is in three weeks and comms is drafting the release."
Statistical Consulting
"We have an End-of-Phase-2 meeting and we don't know what they'll push back on."
Regulatory Support
"There's no precedent for this approach in our indication."
Medical Writing
Not on the list? That's the more interesting conversation. Some of these we answer by telling you who else to call.
The left-hand side of this timeline is where a fix is least expensive and where we matter most.
We specialize in the gray areas: an efficacy signal that is real but small, dropout that isn't random, an endpoint the agency hasn't seen before.
When clinical trial results are messy, automated software doesn't help. You need experts to find insights in your data to maintain study power and integrity. We specialize in the gray areas: an efficacy signal that is real but small, dropout that isn't random, an endpoint the agency hasn't seen before. We have done this 100+ times, so we know what works.
20+
Years in Neurodegeneration
100+
FDA Engagements
9
FDA-Recognized Endpoints
75+
Indications Analyzed
100%
Independent
01
02
03
Progressive disease is the hardest problem in clinical trials: small changes, heterogeneous patients, and a signal that hides in the noise for years. We have worked on it since 2001. The methods we built for it are the ones we bring to every other indication.
20+
Years in neurodegenerative disease.
Self-funded
Research funded internally to protect objectivity.
Indication focus
Everything here serves one goal: getting treatments to the patients waiting for them as quickly as possible, through good trials and well-prepared presentations to the FDA. We have been an integral part of regulatory approvals that did not exist before: treatments for ALS, Friedreich's ataxia, and Prader-Willi syndrome. In many cases these are children's diseases.
Statistical thinking, study design, and regulatory strategy for teams advancing medical research. Each issue takes one problem sponsors actually face and shows what the data can support.
From the newsletter
Example articleA new statistical framework answers the sponsor's real question: How much longer does this drug keep patients where we want them to be?
Suzanne Hendrix, PhDFounder and CEO
Tell us the disease area, the phase, the timeline, and the thing that worries you. Whether it's a design review, an independent second opinion, or a full biostatistics partnership, we will tell you plainly what your data can and cannot support.
