Early phase is where a programme finds its direction. Dose, endpoints, population, feasibility, each answer narrows the next question. We make sure those answers rest on data you can defend, and on a design built to carry your programme into its later phases.
Early phase design choices from dose escalation and endpoint selection to sample size and variability assumptions shape the quality of the evidence you generate. Getting them right gives later development a stronger, more reliable starting point.
We design Phase I so the evidence remains useful beyond the study itself. We make sure the data can directly inform the design of later phases so it can be carried forward without unnecessary rework.
Around one in five of our projects is a Phase I study. That experience helps us judge what the early evidence can support, where uncertainty remains and what needs strengthening before the programme moves on.
Initial clinical studies assessing safety, tolerability and dose escalation in healthy volunteers or patients, including single and multiple ascending dose designs.
Studies that characterise how a drug behaves in the body and how exposure relates to biological or clinical response.
Studies comparing the rate and extent of drug exposure, including crossover and replicate designs used for regulatory assessment.
Studies designed to understand how concomitant medicines or food affect drug exposure, often using crossover or sequence-based designs.
Early patient studies that test whether the treatment shows the expected biological or clinical effect and whether further development is justified.
First-in-human and feasibility studies that assess initial safety, performance and clinical use before larger confirmatory investigations.
Before we shape the study, we define the decision it needs to support. That keeps the design focused on generating evidence that can clearly guide what happens next.
Variability, effect size and attrition can change what a study is able to show. We ground each assumption in the available evidence and test its impact, so you can see where the design is robust and where uncertainty remains.
We structure databases, standards and data with the wider development programme in mind. Early phase data stay usable as the programme progresses, reducing rework and creating stronger continuity into later phases and submission.
You work directly with the statisticians and data managers who know your study, with senior specialists involved throughout. That means clearer conversations, faster answers and expertise that stays connected to the work.
We are a specialised CRO built around biostatistics, data management and medical writing. Early phase design questions are handled directly by the specialists who work with these challenges every day.
Our perspective spans planning and non-clinical support through Phase II and III and post-marketing research, so the advice we give in early phase anticipates what comes next.
As long-standing CDISC practitioners, we structure early phase data to standard from the first study, avoiding expensive retrofitting later.
Small and mid-sized biotechs, medical device companies and academic sponsors get direct access to senior expertise, fast decisions and flexible scope.
Headquartered in Munich with global delivery experience across multiple therapeutic areas, we understand regulatory expectations on both sides of the Atlantic.
Our trial rescue experience includes studies that came to us mid-flight. If an early phase project has stalled, inherited a difficult dataset or needs a second opinion, that conversation is welcome.
Sometimes the hardest part is knowing where to begin. Our senior consultants help you clarify priorities, weigh development challenges, and find the right path forward across study design, statistics, regulatory strategy and data.
Explore consulting services
