anthropics/life-sciences

Overview

This skill generates clinical trial protocols for investigational medical devices or drugs using a modular, waypoint-driven workflow. It supports a Research Only mode for regulatory and literature synthesis and a Full Protocol mode to produce a complete, stakeholder-ready protocol document. The orchestrator preserves progress and resumes from the last completed step.

How this skill works

You start by initializing the intervention (device or drug) and providing any supporting documentation or specifications. The skill runs on-demand substeps: clinical research and FDA pathway analysis, protocol foundations (sections 1–6), intervention details (7–8), operations and statistics (9–12), and final concatenation into a formatted protocol file. Each step is loaded only when executed, progress is saved as waypoint files, and a formatted research summary or full protocol artifact is produced.

When to use it

• When you need a draft clinical protocol for a device or drug to guide study design
• Preparing regulatory submission materials (IND, IDE, 510(k), PMA, De Novo, NDA/BLA)
• When you want automated synthesis of similar trials and FDA guidance before protocol writing
• If you need reproducible, resumable protocol development across multiple sessions
• To create a professional protocol document for stakeholder review or IRB submission

Best practices

• Provide detailed initial context: technical specs, mechanism of action, target population, and any prior data
• Choose Research Only mode first if you need regulatory landscape and similar-trial benchmarking
• Review waypoint outputs between major steps and correct any assumptions before proceeding
• Install required Python dependencies for accurate sample-size calculations (numpy, scipy) and ensure FDA database access
• Keep intervention metadata current so resumed runs pick up the correct next step

Example use cases

• Generate a research summary and recommended regulatory pathway for a novel implantable device
• Design a Phase 2 randomized study protocol for a new oncology drug, with sample size calculation
• Create an operations and monitoring section for a multi-center device trial
• Produce a concatenated protocol document ready for internal review and submission to IRB or regulators
• Resume protocol drafting after interruptions with saved waypoints and incremental outputs