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The clinical trials knowledge hub

Master the rules,
lead with confidence.

Your complete platform for GCP training, ICH guidelines, global regulations and practical templates — for pharma, biotech and medical device teams who need to stay inspection-ready and drive their KPIs, KQIs, and KRIs.

GCP Training · Guidelines · Global Regulations · Inspection Readiness — all in one platform

GCP certification
TransCelerate recognised
ICH E6(R3) · V3.0 · effective 03 Jun 2026
Coverage
Pharma · Biotech · Device
One platform, every track
Core GCP programme
Free to access
M1–M7 · certificate CHF 29
GCP Training · ICH & ISO Guidelines · Global Clinical Regulations · Inspection Readiness — pharma, biotech & medical device
Courses
Everything you need. All in one platform.

Start anywhere. Each pillar cross-references the others — for pharma, biotech, and medical device professionals.

I work in
All professionals
TransCelerate recognised
  • M1–M7 ICH E6(R3) — free
  • 42 GCP principles
  • Investigator & sponsor obligations
Pharma / Biotech
  • 🔒M8–M10 extended — paid
Medical Device
  • GCP for Medical Device Investigations — free

Guidelines Library

Organised by topic

Pharma / Biotech
  • ICH E8(R1) — foundation
  • E2 safety family (6)
  • Study design & statistics
  • Special populations
  • Biomarkers & genomics
  • Modern trial designs
Medical Device
  • ISO 14155 GCP
  • ISO 13485 QMS
Shared — pharma & device
  • CONSORT
  • SPIRIT
  • ICMJE

Global Regulations

9 jurisdictions

Pharma / Biotech
  • EU — CTR, CTIS, GDPR
  • US — FDA, HIPAA
  • CH · UK · AU · JP
  • CA · CN · BR
  • Declaration of Helsinki
Medical Device
  • EU MDR
  • US FDA device regs
  • Switzerland MedDev

Inspection Readiness

Pharma + medical device

Pharma & device
  • FDA, EMA, MHRA
  • Swissmedic
  • TMF readiness
  • CAPA management
  • RBQM in practice
  • Audit preparation

Document templates

Practical regulatory templates for pharma and medical device — designed to complement your training.

All professionals
Pharma / Biotech
Medical Device
Shared — applies to both
ICH E Guidelines
The complete ICH E library

22 ICH E guidelines organised by family. Search by number or browse by topic family.

Find a guideline

Why CTKeys
Why professionals choose CTKeys
🧠

Built for retention

Optimised learning paths, practical tools, and cross-references that make knowledge stick — and drive your KPIs, KQIs, and KRIs.

Stay inspection ready

Content aligned with ICH-GCP, ISO standards and global regulations to help you and your teams prepare for audits with confidence.

👥

For every role

From investigators and study coordinators to CRAs, QA and RA professionals, directors and C-suite — across pharma, biotech and device.

Pricing
Simple. Transparent. Fair.

Start free with the full GCP core programme. Certificate of completion CHF 29. Scale when you are ready.

Free
CHF 0
Always free

Full GCP core M1–M7. TransCelerate recognised. Self-assessments included.

+ Certificate CHF 29
Get Started
Individual
CHF 149
per year

Full library — ICH E, ISO standards, global regulations, inspection readiness, templates.

Get Started
Most popular
Team
CHF 899
up to 10 users / year

Full access for your team with group progress tracking and team certificates.

Get Started
Enterprise
Custom
annual contract

White-label branding, L&D reporting, volume licensing. Contact us to discuss.

Contact Us
About
Built for the people who run clinical trials

CTKeys was built by Isabelle Arrighi, PhD — a clinical research and compliance professional passionate about improving patient lives. She started her career in a lab, grew through evolving roles in project management and team leadership, and became a senior clinical research leader with over 15 years of experience across biotech, pharma, medical nutrition and medical device organisations.

CTKeys is a clinical trial readiness platform designed to support clinical and operational teams in staying consistently inspection-ready. It brings together critical regulations, internal standards, and operational knowledge into one place — with a structured and accessible system.

Built for clarity and practicality, CTKeys helps teams navigate complex clinical trial requirements, improve compliance, and ensure that processes are always aligned with inspection expectations.

Mission

"Master the rules, lead with confidence."

Isabelle Arrighi, PhD
Founder, CTKeys