myLaminin Newletter

Over the past several years, myLaminin has continued to evolve with one goal in mind: helping research organizations replace disconnected systems with a single, integrated Research Data Management platform.

As clinical research becomes increasingly complex with evolving regulatory expectations, growing financial pressures, and expanding operational demands, research teams need technology that brings every stage of the research lifecycle together.

That's why we're excited to introduce the newest addition to the myLaminin Research Data Management platform: our fully integrated Clinical Trial Management System (CTMS). Built for healthcare organizations, hospitals, research institutes, and higher education across Canada and the United States, the new CTMS provides a single source of truth for clinical trial operations, compliance, financial management, and participant oversight.

One Platform. Every Stage of Research.

myLaminin is purpose-built to support the complete research lifecycle.

• Grant Management (Coming Q2 2026)

• IRB / REB Management

• Team & Agreement Management with Adobe Acrobat Sign integration

• Clinical Trial Management (CTMS)

• Electronic Data Capture (EDC) with extensive randomization, PHI data management,  and reporting capabilities

• Research Data Repository Management with National and Indigenous Data Sovereignty support with jurisdictional cloud or on-prem data storage options

• Publishing Capabilities with DataCite, Dublin Core or DDI metadata standard support

Built for Trusted Research.

• ICH E6(R3) Ready

• FDA 21 CFR Part 11 Electronic Signatures

• Audit Trail

• SOC 2 Type II Certified

• US and Canadian Patented Technology

Everything You Need to Manage Modern Clinical Trials

Protocol Definition & Integrated EDC: Define your clinical trial protocols with the ability to link electronic data capture (EDC) forms directly to each step of the trial.

Recover Every Billable Research Dollar: Automatically identify billable participant activities, track sponsor payment schedules, and streamline timesheet-to-invoice workflows to reduce revenue leakage.

Real-Time Participant & Study Oversight: Monitor participant progress, recruitment, milestone completion, and study performance from live operational dashboards.

Integrated eTMF & Investigator Site Files: Manage trial documentation, investigator files, and electronic data capture within a single compliant research platform.

Team Training & Certification: Track trial staff training, certifications, and required qualifications seamlessly within the platform.

Responsibility Assignment & Delegation Log: Maintain an active, airtight delegation of authority log to clearly outline trial roles and responsibilities.

Comprehensive Audit Trail: Benefit from our patented, SOC 2 Type II certified infrastructure featuring an immutable audit trail for every action taken across the entire RDM lifecycle.

Built for the Next Generation of Research Compliance: ICH E6(R3) & FDA 21 CFR Part 11

Regulatory compliance shouldn't come at the expense of research productivity. myLaminin was designed to help research teams satisfy evolving regulatory requirements while simplifying day-to-day clinical trial operations. Our new module delivers complete FDA 21 CFR Part 11 and ICH E6(R3) compliant electronic signature support out of the box.

To meet the rigorous Quality by Design (QbD) and Risk-Based Quality Management (RBQM) protocols of ICH E6(R3), myLaminin empowers your team to:

• Identify and monitor Critical-to-Quality (CTQ) elements.

• Establish Quality Tolerance Limits (QTLs) with automated, instant notifications to catch deviations early.

• Utilize our automated System Validation Package (IQ/OQ/PQ) to streamline, accelerate, and simplify monitoring and audit activities.

Read the full Article

Delivering Real-Time Clinical Trial Operations (RTCT)

As regulators increasingly emphasize Real-Time Clinical Trials (RTCT), research organizations need immediate visibility into study performance, participant activity, financial health, and compliance. myLaminin delivers integrated reporting with data latency of less than five seconds, enabling research teams to make informed decisions as studies progress.

Built for Research Across Multiple Jurisdictions

Research compliance isn't one-size-fits-all. myLaminin simplifies jurisdiction-specific regulatory requirements by providing integrated compliance forms for Canada, the United States, and Australia, with the flexibility to support additional jurisdictions as research programs evolve.

Forms are automatically filtered by jurisdiction and default to the project's region, helping researchers complete the correct regulatory documentation while reducing administrative burden.

For Canadian research, myLaminin includes DMP Assistant integration, STRAC, and NSGRP forms. In the United States, the platform supports the DOE Digital Data Management Plan and NSPM-33 Common Forms. Australian research is supported through Defence Export Controls & Sanctions Review and Indigenous Data Governance & CARE forms.

The myLaminin CTMS module is now fully integrated with our Research Data Management platform. Whether you're managing investigator-initiated research, multi-site clinical trials, or institutional research operations, we'd love to show you how myLaminin can simplify your workflows.

Ready to see the platform in action? Contact us to activate the CTMS module or schedule a personalized demonstration.

But clinical trial management is only part of the research lifecycle. Our vision has always been much broader: creating a connected platform that supports research from funding and ethics review through study execution, regulatory compliance, and long-term data stewardship.

Coming Q2 2026: Grant Management

We are currently in the final stages of testing the myLaminin Grant Management (GM) module which completes our full lifecycle Research Data Management (RDM) platform, transitioning it into a unified, integrated suite. This module is designed to move institutions beyond siloed tools, ensuring that a grant serves as the starting point for a data-driven research journey rather than an isolated document.

Key highlights of the myLaminin Grant Management module include:

Unified RDM Lifecycle: By integrating directly with existing myLaminin modules (IRB/REB, CTMS, and Data Repository), our GM module allows for seamless data flow. For example, grant metadata automatically populates subsequent REB applications, eliminating redundant entry and saving researchers significant time.

Scalable Institutional Governance: The module features highly flexible, configurable routing paths that accommodate unique institutional hierarchies. It supports both sequential and parallel routing, allowing departments to manage approvals, delegate authority during absences, and handle multi-institutional collaborations in real-time without custom code.

"Audit-Ready" Compliance: Leveraging myLaminin’s existing immutable audit trail and security framework, the module provides high-fidelity oversight and centralized reporting, ensuring that compliance is built into the workflow rather than applied after the fact.

Built-in Interoperability: Designed for complex institutional research landscapes, it includes CANARIE CAF and Internet2 integration for secure single sign-on and plans for future System-to-System (S2S) integrations to further streamline the submission process.

Another Major Milestone

We're also proud to announce that myLaminin has been granted a Canadian patent by the Canadian Intellectual Property Office (CIPO), further recognizing the innovation behind our compliance-first Research Data Management platform. This milestone reinforces our long-term commitment to building trusted technology that supports regulated research across healthcare and higher education.

Our mission has never been to build another research application. We're building a connected, compliance-first Research Data Management platform that supports every stage of the research lifecycle; from grant funding and ethics review to clinical trial management, data collection, and long-term research stewardship.

Every new module brings us one step closer to that vision, and we're excited to continue that journey with our partners across healthcare and higher education in Canada and the United States.

Ready to see what's next? We'd be happy to schedule a personalized demonstration of the new CTMS module or discuss how myLaminin can support your institution's research operations.

Beyond the Platform: Research Insights & Perspectives

Building great technology is only part of our mission. We're equally committed to helping research organizations navigate the rapidly evolving world of research governance, regulatory compliance, cybersecurity, and data stewardship.

Through myLaminin Perspectives, we regularly publish practical insights for researchers, research administrators, and institutional leaders on topics including:

• Research cybersecurity and digital trust

• FDA, Health Canada, GDPR, HIPAA, PIPEDA, and PHIPA compliance

• Clinical trials and research operations

• FAIR data principles and research data management

• Synthetic data and AI in research

• Persistent identifiers (RAiD) and research interoperability

• Secure research publishing and digital governance

Explore the complete myLaminin Perspectives: Insights on Research Compliance, Clinical Trials & Data Management library and stay informed on the issues shaping the future of research.

Every research organization is different, which is why we'd love to learn more about yours. Whether you're looking to streamline ethics review, strengthen regulatory compliance, improve clinical trial operations, or unify your research data, we're here to help. Schedule a personalized demonstration to see how myLaminin can support your team.