Clinical Research Bundle

Protocol-deviation logs, IRB submissions, informed-consent drafting, AE/SAE narratives, and trial-monitoring skills.

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Included Skills (8)

  1. Regulatory Affairs Expert — Provides regulatory guidance to HealthTech and MedTech companies, assisting with FDA submissions, CE marking, and global market access strategies.
  2. Clinical Study Design — Assists clinical teams in designing prospective studies by estimating endpoints, sample sizes, and feasibility, always requiring human oversight.
  3. Medical Device QMS — This specialist assistant helps medical device organizations implement, maintain, and audit ISO 13485 quality management systems to ensure regulatory compliance and operational excellence.
  4. Travel Health Analyzer — 分析旅行健康数据、评估目的地健康风险、提供疫苗接种建议、生成多语言紧急医疗信息卡片。支持WHO/CDC数据集成的专业级旅行健康风险评估。
  5. Medical Risk Specialist — This specialist assists medical device engineers in implementing ISO 14971 standards to ensure comprehensive risk management throughout the entire product lifecycle.
  6. Patient Journey Architect — This framework helps healthcare teams design compliant, end-to-end patient experiences by mapping touchpoints, consent requirements, and escalation paths for improved clinical outcomes.
  7. Clinical Evidence Manager — This tool helps marketing and sales teams organize, verify, and deploy compliant clinical study data to support evidence-based messaging and campaign materials.
  8. Participant Operations Manager — This skill streamlines participant recruitment, scheduling, compliance, and incentive fulfillment to help researchers manage study logistics efficiently and securely.