Does the CRO have experience in a specific therapeutic area?
Therapeutic specialization is one of the most important factors in selecting a CRO. Each medical field — oncology, cardiology, diabetology, neurology, psychiatry, immunology and many others — has its own challenges, regulatory nuances and methodological considerations. Experience in a specific therapeutic area allows a CRO to design a more robust study, anticipate risks and tailor the operational strategy to the characteristics of the disease and patient population.
A CRO with relevant therapeutic expertise can select appropriate endpoints, develop a suitable statistical analysis plan, understand safety considerations and support effective patient recruitment. Such a partner can better predict operational risks and address them proactively.
However, sponsors should avoid overly narrow selection criteria. Requirements that are too specific — for example, experience exclusively in pediatric studies in a highly specialised rare disease — may unnecessarily eliminate competent CROs with strong capabilities in similar or related fields. In practice, broad operational experience, flexibility and adaptability are often more important than a perfect match to a single project type.
Biostat® has over two decades of experience across a wide range of therapeutic areas, including oncology, hematology, cardiology, diabetology, neurology, psychiatry, rheumatology, dermatology, pulmonology, transplantation, nephrology, immunology and studies of medical devices under MDR and IVDR.
We work with leading clinical centres in Poland, ensuring high-quality clinical data, regulatory compliance and operational excellence.
Our interdisciplinary team — Project Managers, CRAs, biostatisticians, pharmacovigilance experts and Medical Writers — delivers complete clinical documentation, including protocols, Investigator Brochures and final reports, also for advanced therapy medicinal products (ATMPs).
Our specialization also includes gene therapy, cell therapy and biologics — areas requiring close cooperation with academic centres and laboratory facilities. Our experience confirms our ability to manage high-risk and complex clinical research.
Choosing a CRO experienced in your therapeutic area is an investment in safety, scientific credibility and data reliability.
If you are planning a study in a particular therapeutic field, send us a brief project description — within 1–2 business days we will propose a meeting and share our best practices.
