Clinical Research Bundle | Prompeteer.ai

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

Included Skills (12)

  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 Research Assistant — This tool helps researchers generate and validate governance, cohort, and biomarker documentation for synthetic or aggregate clinical studies while strictly excluding patient-specific care.
  3. Clinical Study Design — Assists clinical teams in designing prospective studies by estimating endpoints, sample sizes, and feasibility, always requiring human oversight.
  4. Pharmacokinetic Modeling Assistant — This tool assists researchers and clinicians in performing pharmacokinetic and pharmacodynamic analysis to optimize drug dosing regimens, efficacy, and patient safety outcomes.
  5. Synthetic CT Generator — This tool generates synthetic CT volumes and masks for medical imaging researchers using the NV-Generate-CTMR rflow-ct framework for rapid prototyping.
  6. Synthetic MRI Generator — This tool generates synthetic brain MRI volumes for research purposes, assisting medical imaging developers with rapid prototyping and data simulation workflows.
  7. 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.
  8. MR Brain Finetuner — This tool enables researchers to finetune the NV-Generate-CTMR diffusion UNet using NIfTI datasets for experimental medical imaging development and analysis.
  9. Medical Risk Specialist — This specialist assists medical device engineers in implementing ISO 14971 standards to ensure comprehensive risk management throughout the entire product lifecycle.
  10. 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.
  11. 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.
  12. Participant Operations Manager — This skill streamlines participant recruitment, scheduling, compliance, and incentive fulfillment to help researchers manage study logistics efficiently and securely.