Clinical Strategy
Structured Clinical Evidence Development to Support Investigational Pathways
Our Clinical Strategy Services Overview
Investigator’s Brochure (IB) Development
- Creating or updating Investigator Brochures for clinical investigations
- Summarizing device mechanism, safety, performance, and known risks
Clinical Study Protocol (CSP) Development
- Protocol drafting for PMCF studies, feasibility studies, registries
- Designing endpoints, sample size logic, and methodology at a strategic level
Protocol Synopsis / Study Concept Notes
- High-level study design summaries for early planning
- Useful for NB/FDA scientific discussions
Informed Consent Form (ICF) Development
- Drafting and aligning ICFs with ethical and regulatory expectations
- Ensuring clarity and risk transparency for study participants
Clinical Investigation Plan (CIP) Strategy
- Designing the structure of CIPs
- Mapping clinical objectives and justification for investigations
Case Report Form (CRF) Design Strategy
- High-level CRF structure
- Capturing relevant safety & performance data
Clinical Monitoring Plan (CMP) Development
- Strategy for monitoring study sites, data, and compliance
Statistical Analysis Strategy
- High-level definition of statistical endpoints
- Analysis sets and statistical models
Clinical Study Feasibility Assessment
- Determining whether a study is required, feasible, and appropriate
- Comparator and endpoint recommendations
Ethics & Regulatory Submission Package Support
- Preparing clinical sections for EC submissions
- Supporting regulatory documentation for study approval
Lay Summary / Plain Language Summary Development
- Patient-friendly summaries for clinical investigations
- Includes PMCF study summaries
Clinical Study Report (CSR) Strategy
- Outlining structure for CSR creation
- Key messages and evidence alignment
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Contact Our MedTech Experts
Cetas Healthcare is the world’s leading boutique MedTech market research firm. We blend agency-grade research with strategic intelligence frameworks to track pipelines, regulatory shifts, clinical trials, and GTM strategies. As pioneers of ISO 14155-compliant PMCF surveys, we’ve managed 25,000+ patient case forms for Class II & III devices, helping clients secure CE certifications and stay ahead of EU MDR requirements.
Contact Us: communication@cetas-healthcare.com
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