The program exists in fragments
Protocol drafts, vendor quotes and timelines live in different documents and do not yet describe one coherent development path.
Boutique clinical development advisory
We help biotechnology companies move clinical development forward with senior expertise.
Oceta Group brings together experienced clinical research and drug development specialists. You work directly with senior advisors who have led international studies, not with an account layer or a junior delivery team.
- A group of senior clinical research specialists
- Phase I to IV international trial experience
- Clinical development strategy and program management
- Medical monitoring and study oversight
- Regulatory and scientific advisory
- Fractional clinical leadership for biotechnology companies
Oceta Group supports biotechnology companies throughout clinical development, from first-in-human planning to late phase execution.
I to IV
Trial phases led and supported by our experts
10+
Years of clinical research experience per advisor
Global
Multicountry studies and international collaborations
Multiple
Institutional collaborations across our team
Where teams usually are
You do not need a large CRO. You need experts who have already done this.
Most companies reach us while preparing a first-in-human or Phase II study, answering diligence questions from investors, or carrying a clinical program without senior clinical leadership in house. The gap is rarely budget. It is experienced judgment applied early, when decisions are still inexpensive to change.
Investors are asking harder questions
Diligence moves from science to execution: feasibility, sites, endpoints, safety oversight, regulatory sequence and realistic timelines.
There is no senior clinical leadership in place
A CMO hire is months away and the study cannot wait. Our experts provide that leadership now, at the level of involvement the stage requires.
Execution risk stays invisible until it is expensive
Protocol design choices, site selection and monitoring plans decide whether a study recruits and whether the data will hold.
How we work
A small group of senior specialists with complementary expertise
Each engagement is staffed with the advisors whose experience matches the question in front of you. Medical strategy, operations, safety, regulatory and training expertise sit in one group, so you do not have to assemble them yourself.
Senior only
Work is delivered by experienced specialists. Nothing is handed to a junior delivery team.
Complementary expertise
Strategy, operations, medical oversight and regulatory support combined within one team.
International reach
Experience across multicountry studies, ministries of health, academic networks and international organizations.
Scientific rigor
Development plans that hold up in front of regulators, ethics committees, boards and investors.
Our experts
Senior specialists behind every engagement
Oceta Group is built around experienced clinical research professionals. Each expert brings a distinct area of depth, and engagements are staffed accordingly.
Dr. Juliana Quintero Pulgarín
Medical Doctor and Clinical Research Physician, International Consultant
Clinical development strategy / Medical monitoring and patient safety / Clinical operations and study oversight / Clinical research training and ICH-GCP
Services
Strategic clinical development expertise, organized around the problem you have.
Engagements are scoped to a defined question or a defined phase of work. Some companies need a development plan they can defend in front of a board. Others need a team accountable for the study while it runs.
How engagement works
What happens after you write
The process is short on purpose. Most clients move from first conversation to signed scope within two weeks.
- 01
Discovery call
Forty five minutes on your asset, stage, timeline and the decision in front of you. No preparation needed.
- 02
Scope
The question is defined in writing, along with what is inside and outside the engagement.
- 03
Team
The experts whose experience fits the work are named before anything starts.
- 04
Proposal
Deliverables, involvement level, duration and fees on one page.
- 05
Delivery
Working sessions with your team, written deliverables, and direct participation where it is useful.
- 06
Knowledge transfer
Documentation and handover so the capability stays inside your company after the engagement ends.
Industries served
Where our work fits
Biotech
Biotechnology companies preparing first-in-human studies or advancing a clinical program.
Specialty pharma
Companies expanding indications or entering new regions.
Academic research
Spin-outs and investigator-led programs moving toward regulated studies.
Public health
Programs at the intersection of research, ministries and health services.
International organizations
Multi-country initiatives requiring clinical research oversight.
Global health
Neglected and infectious disease research with international partners.
Oceta Group brings together experienced clinical research and drug development specialists. You work directly with senior advisors who have led international studies, not with an account layer or a junior delivery team.
Book an introductory conversation