Helping emerging biotech companies build high-performing clinical development organizations
Request a consultationClinOps Strategy Consulting partners with biotechnology and life sciences companies to design, build, and optimize Clinical Operations organizations that consistently deliver high-quality clinical trials — on time, on budget, and with confidence.
Drawing on more than 25 years of global Clinical Development and Operations leadership, we provide strategic and operational expertise that enables organizations to scale efficiently, strengthen governance, reduce execution risk, and accelerate development timelines — through practical, data-driven solutions tailored to each company's stage of growth.
Bio
Rita Amirana is the Founder of ClinOps Strategy Consulting, bringing more than 25 years of global Clinical Development and Operations leadership across biotechnology and life sciences organizations. Her career spans the full development lifecycle, from first-in-human studies through registration, with responsibility for globally conducted trials.
She has built and led Clinical Operations functions at multiple stages of company growth: standing up the capability for teams running their first trial, scaling organizations through rapid portfolio expansion, and strengthening governance and quality systems in preparation for regulatory inspection. Her work consistently pairs operational rigor with pragmatism — translating development strategy into staffing plans, vendor models, timelines, and metrics that leadership teams can act on.
Rita holds an MBA from MIT Sloan School of Management, along with an MA and a BSc, and advises clients worldwide from her base in Massachusetts, USA.
- Gene therapy
- Cell therapies
- RNA therapeutics
- Biologics
- Immunotherapy
- Small molecules
- Neurology (chronic and acute)
- Neuromuscular disorders
- Ophthalmology
- Rare diseases
- Cardiology
- Metabolic disorders
- Immunology
- Oncology
Core Services
Engagements are scoped to the capability you need next — leadership, structure, governance, execution, or oversight.
- Fractional Clinical Operations leadership
- Clinical development operational strategy
- Organizational design and scaling
- Capability gap analysis and advisory
- Clinical Operations team building
- Capability and competency assessments
- Skills gap analysis
- Leadership development
- Role definition and organizational structure
- Portfolio governance frameworks
- Development planning support
- Cross-functional operating models
- Risk identification and mitigation
- Executive dashboards and performance metrics
- Protocol design
- Predictable trial planning
- Operational feasibility assessments
- Study startup strategy
- Enrollment acceleration planning
- Global trial execution support
- CRO selection and RFP development
- Vendor evaluation
- Governance models
- Performance management
- Partnership optimization
- Clinical Quality Management Systems (QMS)
- SOP development and implementation
- Inspection readiness
- Continuous improvement initiatives
- KPI development
- Portfolio performance metrics
- Operational feasibility analysis
- Executive reporting
- Strategic operational insights
How Engagements Work
Four flexible models, sized to your stage of growth and adjusted as your needs change.
Who We Serve
Work spans therapeutic areas, trial phases, and geographies. If your clinical organization needs to do more than its current structure allows, the conversation is worth having.
Request a Consultation
Tell us briefly what you are working on and we will follow up to arrange an introductory conversation.