If I only have an idea, can a CRO help me design the study and develop the protocol?

Absolutely. Working with a full-service CRO like Biostat® does not require you to have a finished study design or complete documentation. A goal, a hypothesis, or even a general outline is enough — our interdisciplinary team will transform it into a professional, coherent and feasible study plan.

We begin with a joint conceptual workshop to precisely define what you want to study and why it matters. Based on this, we develop a final study concept, clearly outlining objectives, study population, endpoints and potential variables that may influence outcomes. This ensures that your project is scientifically sound and operationally feasible from the very beginning.

The next step is selecting the appropriate methodology and calculating the sample size required to test your hypotheses with sufficient statistical power. Our biostatistics department develops advanced models to determine the optimal study structure — from simple single-center trials to complex multicenter or hybrid designs.

We also advise on best practices in study design: selecting accurate endpoints, defining inclusion and exclusion criteria, and shaping the schedule of assessments, visits and data collection. If your project requires non-standard solutions — such as telemedicine visits, eCRF, or remote patient monitoring — we incorporate them at the planning stage, ensuring your study is ready for modern digital challenges.

We then prepare the full set of protocol assumptions, including methodology, eligibility criteria, treatment pathways, assessment schedule and statistical analysis plan. Everything is aligned with current regulations and guidelines, including ICH GCP E6(R3), EU CTR 536/2014, EU MDR and national regulations for clinical and observational studies.

Thanks to our experience in both commercial and academic projects, we can also create a realistic timeline and budget based on your resources, risks and expectations. If needed, we help identify suitable research sites through our network of clinics, hospitals and academic centers.

For studies requiring external funding, we also support the preparation of grant applications — including national (NCBR, ABM) and EU programmes (Horizon Europe, EIT Health).

The result of working with Biostat® is a complete package of documents ready for submission to regulatory and ethics bodies — fully compliant with ethical and legal requirements. It is an end-to-end solution that allows you to move from an idea to a ready-to-launch study without having to assemble your own methodological or biostatistics team.

In practice, this means you can focus on the scientific content — while we take care of everything else, ensuring your study is designed professionally, efficiently and in line with current scientific standards.