PIS/ICF Design According to Local Regulations
MEDIKAPOLI CRO provides expert preparation and design of Patient Information Sheet (PIS) and Informed Consent Form (ICF) in full compliance with local regulatory and ethics committee requirements. Our team ensures that all documents are clear, ethically sound, and aligned with applicable regulations while maintaining patient rights, safety, and transparency.
We carefully structure PIS/ICF documents to present study information in an understandable and patient-friendly manner, covering study purpose, procedures, potential risks and benefits, confidentiality, and voluntary participation. All documents are prepared in accordance with ICH-GCP guidelines and local authority standards to support smooth ethics submissions and approvals.
Through our regulatory expertise and attention to detail, we help sponsors minimize revisions, accelerate approval timelines, and ensure full compliance throughout the clinical research process.