The Company Behind the LMS for Clinical Research Organizations
Purpose-Built for GCP Compliance Since Day One
We are a team of clinical research professionals, regulatory compliance experts, and learning technology engineers united by a single mission: to make the LMS for clinical research organizations that regulators trust and CROs rely on. We didn't adapt a corporate training platform — we built one specifically for the GCP-regulated world of clinical trials.
We Exist to Protect Clinical Trial Integrity Through Better Training
The LMS for clinical research organizations is not just a software category for us — it is our founding purpose. When a clinical trial fails an FDA inspection due to training record gaps, patients are harmed: data is questioned, results are delayed, and therapies that could save lives are held up in remediation.
We built this platform because we worked inside CROs and saw firsthand how inadequate training management systems contributed to those failures. Every feature we have built, every regulatory mapping we maintain, and every integration we develop is in service of one goal: ensuring that no clinical trial fails because of preventable training compliance gaps.
"A clinical trial is only as strong as the training of the people conducting it. We built the LMS for clinical research organizations that makes GCP compliance inevitable — not accidental."— Founding Team, Clinical Compliance Platform
From CRO Frustration to Industry Standard
A decade of building the LMS for clinical research organizations that the industry actually needed — not the generic platform it was forced to use.
Founding Insight from the Field
Our founders, working as QA Director and VP Operations at a Phase II/III CRO, received a Form 483 citing inadequate training records across 22 investigator sites. The root cause was not negligence — it was an LMS that simply wasn't built for clinical research. That observation started the company.
Launch of GCP-Native LMS v1.0
After two years of development with input from 14 CROs and regulatory consultants, the first purpose-built LMS for clinical research organizations launched with native ICH E6 mapping, delegation log cross-reference, and protocol-specific training curricula.
EMA, MHRA & Multi-Regulatory Support
As customers expanded into Europe and Asia-Pacific, we added EMA GCP Directive mapping, MHRA compliance frameworks, TGA alignment, and PMDA Japan GCP requirements — making our platform the first truly multi-regulatory LMS for clinical research organizations.
First LMS to Support ICH E6(R3) Natively
When ICH E6 Revision 3 was finalized, we were the first LMS for clinical research organizations to release a complete mapping update — ensuring all customers were ICH E6(R3) compliant from day one, with automated retraining assignments triggered for all active users.
600+ Organizations, Zero Training Gaps
Today, our LMS for clinical research organizations is trusted by more than 600 CROs, sponsor organizations, and investigator site networks across 48 countries — processing over 4 million training completions annually with a 99% FDA inspection pass rate.
What We Stand For
🧬 Clinical Research First
Every product decision starts with one question: does this serve the compliance needs of clinical research organizations? We do not build features for generic corporate training — only for GCP-regulated environments.
⚖️ Regulatory Honesty
We do not overclaim. When we say our platform is FDA BIMO inspection-ready or ICH E6(R3) compliant, we provide the specific evidence, mapping documents, and validation records to prove it. No marketing without documentation.
🔐 Data Integrity Above All
Training records in clinical research are not just compliance artifacts — they are part of the data package that supports drug approval decisions. We treat data integrity with the same rigor as a GLP laboratory.
🤝 Partner, Not Vendor
Our customers' inspections are our inspections. When a regulatory authority challenges a training record, our team is available to support the response — not just the software vendor who sold you a license.
🌍 Global Regulatory Currency
Regulatory frameworks evolve constantly. We maintain a dedicated regulatory intelligence team that monitors FDA, EMA, MHRA, TGA, and PMDA guidance updates — and proactively updates the platform so customers are never caught behind.
Built by People Who Have Run Clinical Trials
Our team is not a group of software engineers who learned about GCP from textbooks. We are former CRO executives, regulatory affairs professionals, and clinical QA managers who lived the problems our platform solves.
GCP Regulatory Intelligence
Dedicated regulatory intelligence unit staffed by former FDA reviewers and MHRA GCP inspectors. We publish quarterly regulatory update reports for all customers — free of charge.
Clinical Technology Integration
Deep technical expertise in CTMS, eTMF, EDC, and IRT systems. Our integration engineers have built certified connectors to 18 clinical technology platforms used by major CROs globally.
Computer System Validation (CSV)
Full GAMP 5 validation support for every implementation — including pre-written IQ, OQ, and PQ protocols reviewed by our in-house CSV specialists with pharma regulatory experience.
GCP Training Content Development
Proprietary GCP content library developed with clinical pharmacologists, biostatisticians, and regulatory writers — mapped to specific ICH E6(R3) requirements and updated with each revision.
Global Regulatory Affairs
Coverage across FDA, EMA, MHRA, TGA, PMDA, Health Canada, ANVISA, and COFEPRIS — enabling global CROs to manage training compliance for all their regulatory jurisdictions in one platform.
Data Security & Privacy
ISO 27001 certified, GDPR Article 89 compliant, and SOC 2 Type II audited annually. Personal data of clinical trial staff is handled with the same data integrity standards as clinical trial data.
The Team Behind the LMS for Clinical Research Organizations
Each member of our leadership team has held senior roles inside CROs, pharmaceutical companies, or regulatory agencies — bringing lived experience to every product decision.
Former VP Operations at a global Phase III CRO. Received the Form 483 that inspired this company. 18 years in clinical research operations across oncology and rare disease.
Former FDA BIMO Inspector and EMA GCP auditor. Expert in ICH E6(R3), 21 CFR Part 312, and clinical site qualification. Leads all regulatory mapping and compliance advisory work.
15 years building validated software systems for FDA-regulated environments. Led CSV programs at two top-10 global CROs before co-founding the platform. GAMP 5 specialist.
Former Director of Training at a 5,000-person full-service CRO. Managed GCP training programs spanning 60+ countries. Leads our customer implementation and compliance success team.
The Credentials Behind the Compliance Claims
In the GCP world, trust is earned through documented evidence — not marketing language. Here is what backs every claim we make about our LMS for clinical research organizations.
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✓GAMP 5 Category 4 Validated Software Full validation package including IQ, OQ, and PQ protocols — pre-written and reviewed by our in-house CSV team. Available on request before purchase.
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✓ISO 27001 Information Security Certification Annual third-party certification for information security management. Certificate and audit summary available to prospective customers under NDA.
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✓SOC 2 Type II Audit Report Annual SOC 2 Type II audit covering security, availability, and confidentiality. Report shared with enterprise customers during due diligence.
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✓GDPR Article 89 Data Processing Compliance Data Processing Agreements, adequacy documentation, and sub-processor lists provided to all EU/EEA customers. Privacy by design architecture.
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✓ICH E6(R3) Regulatory Mapping Document Full written mapping of platform features to specific ICH E6(R3) sections — available to all customers and prospective evaluators upon request.
Validated. Certified. Inspection-Ready.
Every credential that clinical research organizations require before onboarding a regulated software system — we have it documented and ready.
GAMP 5 Cat. 4
IQ/OQ/PQ documentation, change control, and validated deployment process.
ISO 27001
Information security management system certified by accredited third-party body.
SOC 2 Type II
Annual audit of security, availability, and confidentiality controls by independent auditor.
GDPR Compliant
Article 89 research exemption compliance with full DPA and sub-processor documentation.
21 CFR Part 11
Electronic records and e-signature compliance validated for FDA-regulated use.
ICH E6(R3) Mapped
Full written regulatory mapping to ICH E6 Revision 3 — updated within 30 days of guidance changes.
Ready to Partner With the GCP Training Experts?
Join 600+ clinical research organizations that have made GCP compliance training a competitive advantage — not a compliance risk.