Phase 1 Clinical Trial Design -- 2

I am launching a first-in-human, Phase 1 clinical trial and need end-to-end support to ensure every document, plan, and process meets global ICH-GCP standards. The sole objective of this study is to assess the safety and tolerability of our investigational product, so the design must put rigorous safety oversight front and centre.

You will receive the full pre-clinical package and CMC data from me; your task is to convert these into a complete study dossier, guide the start-up process, and set up a reliable data-capture workflow.

Deliverables (all in English):
• A dose-escalation protocol with clear stopping rules, DSMB charter, and real-time safety monitoring plan.
• Informed consent form, investigator’s brochure, pharmacy manual, and CRFs built in REDCap, Medidata Rave, or a similarly compliant platform.
• A statistical analysis plan focused on descriptive safety endpoints, prepared in SAS or R.
• Ethics and regulatory submission packages with draft cover letters and response templates.
• A CSR outline following ICH E3, ready for final population once the study closes.

Acceptance criteria: every document must align with ICH E6(R2) and 21 CFR Part 11; an internal QA review must return no major findings.

Proven experience in early-phase trials, pharmacovigilance, and EDC configuration is critical. If you have redacted protocol samples or CSR excerpts from past first-in-human studies, please mention them so I can gauge fit. Timelines are flexible—we will prioritise compliance and scientific rigour over speed.