Medical Device Study Protocol Development
Budget: ₹12,500 – ₹37,500 INR
I need a full-length clinical protocol for a prospective study of a therapeutic device aimed at cardiovascular diseases. The document must spell out, in detail, the study design and methodology—from objectives and endpoints through randomisation strategy, sample size rationale, visit schedules, statistical framework, and regulatory alignment (FDA/GxP, ISO 14155).
Clear, publication-ready language is essential, supported by current literature and guidelines. Please build in logical flow tables, schema diagrams, and reference lists so the final file can be submitted directly to our IRB and regulatory partners without additional editing.
Deliverable: one protocol manuscript (Word) plus any supporting figures or tables in editable format. If you have firsthand experience drafting cardiovascular device protocols and navigating US or EU ethics submissions, your insight will be valuable as we refine risk language and data-capture tools in later phases.
Clear, publication-ready language is essential, supported by current literature and guidelines. Please build in logical flow tables, schema diagrams, and reference lists so the final file can be submitted directly to our IRB and regulatory partners without additional editing.
Deliverable: one protocol manuscript (Word) plus any supporting figures or tables in editable format. If you have firsthand experience drafting cardiovascular device protocols and navigating US or EU ethics submissions, your insight will be valuable as we refine risk language and data-capture tools in later phases.