Oceta Group

Services

What Oceta Group is engaged to do

Every service states who it is for, when it is usually needed, and what you receive at the end. Work is delivered by our experts, not subcontracted.

01

Clinical Development Strategy

Who needs it
Founders, CEOs and clinical development leaders preparing to move an asset into or through the clinic.
When
Before protocol writing, during fundraising, or when the development path needs to be defended externally.
What you receive
A written development plan: phase sequence, study objectives, endpoints, population, feasibility assumptions, risks and decision points.

02

Clinical Program Management

Who needs it
Teams running one or more studies with limited internal clinical operations capacity.
When
From start-up through database lock.
What you receive
Program governance: timelines, deliverables, vendor oversight, risk log and reporting your team and investors can read.

03

Clinical Trial Operations

Who needs it
Sponsors preparing to activate sites or recover a study that is behind plan.
When
Study start-up, slow enrollment, or site performance issues.
What you receive
Feasibility and site strategy, start-up plans, enrollment recovery measures and practical operational documents.

04

Medical Monitoring

Who needs it
Studies requiring physician oversight of eligibility and safety.
When
From first patient in until last patient out.
What you receive
Medical review of eligibility, safety events and data queries, with documented decisions and site medical support.

05

Study Oversight

Who needs it
Sponsors who have delegated execution to a CRO and remain accountable for it.
When
For the duration of the study.
What you receive
Independent sponsor oversight: CRO performance review, quality signals, escalation paths and inspection readiness.

06

Regulatory Support

Who needs it
Teams preparing submissions to regulators and ethics committees.
When
Submission preparation, questions from authorities, or amendments.
What you receive
Submission planning, document review and structured responses to authority and committee questions.

07

Clinical Research Training

Who needs it
Sponsors, sites and academic groups building clinical research capability, including ICH-GCP.
When
Before study start, during onboarding, or ahead of audits and inspections.
What you receive
Tailored training sessions and materials grounded in real study situations, delivered in Spanish or English with documented completion.

08

Fractional Clinical Leadership

Who needs it
Companies that need senior clinical leadership without a full-time executive hire.
When
Between CMO hires, during a first clinical study, or while a program scales.
What you receive
A named senior clinical leader accountable for the program, joining your internal meetings, vendor calls and board preparation.

09

Scientific Advisory

Who needs it
Boards, investors and management teams needing an independent medical and scientific view.
When
Diligence, portfolio review, protocol design, or before a go and no-go decision.
What you receive
A direct written assessment of clinical assumptions, protocol feasibility, risks and alternatives.

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.

  1. 01

    Discovery call

    Forty five minutes on your asset, stage, timeline and the decision in front of you. No preparation needed.

  2. 02

    Scope

    The question is defined in writing, along with what is inside and outside the engagement.

  3. 03

    Team

    The experts whose experience fits the work are named before anything starts.

  4. 04

    Proposal

    Deliverables, involvement level, duration and fees on one page.

  5. 05

    Delivery

    Working sessions with your team, written deliverables, and direct participation where it is useful.

  6. 06

    Knowledge transfer

    Documentation and handover so the capability stays inside your company after the engagement ends.

You do not need a large CRO. You need experts who have already done this.

Book an introductory conversation