Plan your work, and work your plan

Strategic planning aligned with global regulatory expectations, covering every phase from study concept to market approval.

• Defining study objectives and endpoints.
• Selecting study population, eligibility criteria, and appropriate controls.
• Designing optimal study frameworks
• Statistical methodology support: sample size, power calculations, modeling

Identifying ideal geographies for study conduct and evaluating feasibility.

Anticipating execution challenges and embedding mitigation strategies early.

Expert guidance on CTA submissions, import/export regulations, and regulatory responses.

• Quantity projections and overage planning
• Comparator Sourcing
• Packaging and labeling guidance by region
• IP Management Plan creation

• SOP development, assay setup, validation, and quality control
• Multi-lab assay standardization
• Laboratory capability building across academic and government setups globally

Project-level financial audits of trial sites and subcontractors