About
A boutique group of clinical research and drug development experts supporting biotechnology companies throughout clinical development.
Oceta Group exists because biotechnology companies often need senior clinical judgment before they need a large organization. We bring together specialists who have designed, led and overseen international clinical studies, and we apply that experience to the decisions in front of your program.
A small group of senior clinical research and drug development professionals. Each member has led work inside clinical programs rather than only advising from outside them. Engagements are staffed by the experts whose experience matches the question, and the people who scope the work are the people who deliver it.
We are not a CRO and we do not compete with one. CROs execute at scale. Our role is strategy, medical judgment, program design and sponsor side oversight, including oversight of the CRO you have already selected.
A development plan is a sequence of decisions, and most of the cost is committed early. Endpoints, population, feasibility assumptions and site strategy determine whether the study recruits and whether the data will support the next phase. We work on those decisions before they harden.
Our experts have worked across countries, ministries of health, academic networks and international health organizations. Multicountry research teaches something specific: a protocol written without local reality does not recruit, and a study that ignores its investigators does not produce reliable data.
Development plans have to hold up in front of regulators, ethics committees, boards and investors. Our work is documented, defensible and written so your team can use it after the engagement ends.
Our experts train physicians, investigators and study teams in research methodology and ICH-GCP. Teaching keeps the work honest. It requires explaining not only what a standard says, but why it exists and how it applies at the site on a difficult day.
Detailed credentials for each expert are available on request.
Strategic clinical development expertise, organized around the problem you have.
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