🇨🇭 Quality & Compliance

Quality Management System

Clinical research quality and compliance standards

Delivering rigorous quality and regulatory compliance to secure inspection-ready, reliable, and efficient clinical trial execution.

Request a Demo Explore oomnia
ISO 9001 ISO 27001 GDPR 21 CFR Part 11 CDISC

Our Commitment

Quality and compliance at Wemedoo

Wemedoo's commitment to quality and compliance guides every aspect of our clinical research technology and services. We operate within certified quality frameworks and regulatory best practices to ensure secure, reliable, and inspection-ready clinical trial operations.

As an ISO 9001 and ISO 27001 certified organization, we maintain structured quality and information security management systems. As members of CDISC, we align our data architecture with global interoperability and clinical data standards.

Wemedoo Quality Management System wheel showing five guiding principles: Customer centricity, Quality, Diversity and inclusiveness, Reliability, and Data-driven

Certification

Our proof of quality

We are ISO 9001 and ISO 27001 certified. Our commitment to robust information security & superior quality management is at the core of our innovative solutions, ensuring reliable & efficient trial management for our clients.

  • ISO 9001

    Quality Management System certification ensuring structured, consistent, and continually improving processes across all services and technology delivery.

  • ISO 27001

    Information Security Management System certification protecting the confidentiality, integrity, and availability of clinical trial data and organizational information.

  • CDISC Member

    Active CDISC membership aligning our data architecture with global interoperability and clinical data standards for seamless regulatory submissions.

Wemedoo Expert Perspective

Quality as a strategic mindset

"Compliance is more than a requirement; it's a narrative of responsibility, integrity, structure, and purpose. At Wemedoo, we turn quality into a mindset, not a manual."
Dusan Goljic, MPharm
Director of Quality Management, Wemedoo

Standards & Guidelines

Regulatory framework and industry best practices

While the standards shape our operations, best practices in quality guide them. We embed GCP, 21 CFR Part 11, and EMA guidelines into our processes, ensuring that every step aligns with regulatory expectations for data integrity and patient safety.

In parallel, we integrate GAMP5 principles across system development, delivery, and production, creating a robust guiding framework. By applying these guidelines across multiple layers of our organization, we bridge the gap between clinical and technical excellence, delivering products and services of uncompromising quality.

GCP
Good Clinical Practice
21 CFR Part 11
FDA Electronic Records
EMA Guidelines
European Medicines Agency
GAMP5
System Development Principles

Our Principles

Guiding principles of quality excellence

We are committed to providing reliable, fit-for-purpose solutions that consistently meet regulatory requirements and the evolving needs of our clients. Our quality policy includes customer focus, leadership, people's engagement, process orientation, continuous improvement, evidence-based decision-making, and effective relationship management. Embedded in a technology-driven and service-based approach, these quality principles ensure the excellence of our products.

  • Customer centricity

    Wemedoo is striving to consistently exceed clients' expectations by understanding both current and future needs. The company treats every client interaction as an opportunity to deliver greater value, ensuring requirements are clearly defined, legally compliant, and fulfilled on time.

  • Quality

    Switzerland's reputation for precision and quality sets a global benchmark. At Wemedoo, we apply the same standards to the clinical data our systems process and protect. Through continuous improvement, we refine our processes to ensure sustained excellence and reliability.

  • Diversity & inclusiveness

    Our commitment to diversity and inclusion reflects our global reach and respect for different perspectives. Our software solutions are designed to be globally accessible and to support diverse patient populations across regions and healthcare systems.

  • Reliability

    Reliability is at the core of our solutions. Our software is built to perform consistently, day in and day out, delivering stable results without disruption or variation. You can trust our technology to maintain the same high standard of performance over time.

  • Data-driven

    We take a data-driven approach to ensure quality, accuracy, and continuous improvement. We base our solutions on validated data, clear insights, and ongoing evaluation, supporting informed decisions and meaningful improvements in healthcare.

Regulatory Compliance

Compliant with regulatory standards

  • Swiss nDSG

    Fully aligned with the Swiss Data Privacy Law, ensuring compliant handling of personal data within Swiss and international clinical research contexts.

  • FAIR & ALCOA+

    Data integrity principles embedded throughout — ensuring data is Findable, Accessible, Interoperable, Reusable, Attributable, Legible, Contemporaneous, Original, and Accurate.

  • HIPAA

    Controls and safeguards aligned with HIPAA requirements for the protection of individually identifiable health information in clinical trial operations.

  • GDPR

    GDPR-aligned data protection and privacy controls governing the processing of personal data across all Wemedoo solutions and clinical research engagements.

  • GCP

    Good Clinical Practice guidelines embedded across all trial workflows, ensuring ethical and scientific quality standards are maintained throughout the study lifecycle.

  • 21 CFR Part 11

    Fully compatible with 21 CFR Part 11 electronic records and e-signature requirements for FDA-regulated clinical trial data and documentation.

Get Started

Your research matters

  • Transform how you run clinical trials

    See how Wemedoo combines scientific expertise and technology to support your research.

    Learn more

  • See Wemedoo in action

    Book a personalized demo and learn how Wemedoo helps you execute trials with confidence.

    Book a demo

  • Pricing that scales with your studies

    Explore our pricing plans and find the right fit for your team.

    View pricing

Frequently asked questions

Which quality standards and certifications does Wemedoo follow?

Wemedoo operates under the ISO 9001 standard for Quality Management System and ISO 27001 for Information Security Management System. We also align with ICH guidelines and CDISC standards to ensure compliant operations as well as structured, interoperable, and high-quality clinical data.

How does Wemedoo ensure regulatory compliance in clinical research?

Wemedoo ensures regulatory compliance in clinical research by embedding global regulatory, data‑protection, and quality requirements directly into its system design, validation, delivery, and operational processes. The system is built to meet key industry standards, including 21 CFR Part 11, HIPAA, GDPR, and ICH GCP, ensuring that all captured and processed clinical data adheres to stringent regulatory expectations.

How does Wemedoo align with Good Clinical Practice (GCP) guidelines?

Wemedoo aligns its quality framework with the core principles of GCP R3 to ensure patient safety, data integrity, and ethical conduct throughout the clinical trial lifecycle. GCP requirements are reflected in our system design, operational processes, and governance models, supporting controlled access, traceability, documentation, and oversight.

How does Wemedoo ensure data integrity and reliability?

Wemedoo ensures data integrity and reliability through validated systems, secure data handling, and full end-to-end traceability. Quality controls are embedded across data capture, processing, storage, and reporting, aligned with ALCOA+ data integrity principles and CDISC standards, to support trustworthy clinical data throughout the trial lifecycle.

How does Wemedoo's quality framework benefit clients?

Wemedoo's quality framework provides clients with confidence that their studies are supported by reliable, secure, and fully compliant technology and services. Through certified quality and information security systems and the integration of regulatory best practices, we ensure consistent performance, data integrity, and audit readiness.

How are system validation and change management handled under quality guidelines?

System validation and changes are managed through controlled quality processes, including documented impact assessments, testing, approval of workflows, and full traceability, in line with ICH GCP R3 and ISPE GAMP5 recommendations.

How does Wemedoo stay aligned with evolving regulatory guidelines?

Wemedoo's quality team continuously monitors regulatory updates and industry guidance, regularly reviewing and updating internal processes and systems to remain aligned with current quality and compliance expectations.

How does Wemedoo support Quality by Design in clinical research systems?

Wemedoo supports Quality by Design by embedding quality principles directly into the design of its clinical research information system. Built-in controls across data models, workflows, and governance ensure consistent data quality, traceability, and reliability throughout the clinical research lifecycle.

How does Wemedoo ensure high-quality performance and reliability of the oomnia?

Wemedoo ensures system performance and reliability through its unified clinical research information system architecture, which reduces fragmentation and eliminates inconsistencies across tools. This architecture enables faster setup times, real-time trial oversight, and seamless interoperability across modules such as EDC, RTSM, eTMF, CTMS, eSource, and ePRO.

How is data integrity preserved across unified modules such as EDC, eTMF, RTSM, and eSource?

Wemedoo preserves data integrity through its unified, interoperable architecture, ensuring that all clinical data streams, EDC, RTSM, eTMF, CTMS, ePRO, eCOA, and eSource, work as intrinsic parts of one connected system, thus eliminating manual transfers and reducing risks of data loss, mismatches, or version inconsistencies.

What security measures support Wemedoo's commitment to quality and patient data protection?

Wemedoo's security foundation includes compliance with ISO 27001, ensuring systematic management of sensitive information and strong information security controls. The oomnia system further aligns with HIPAA, GDPR, 21 CFR Part 11, and ICH GCP, embedding secure data handling, access controls, audit trails, and encryption mechanisms into system design, validation, and operations.

How does Wemedoo handle deviations, nonconformities, or quality events?

Wemedoo's ISO aligned Quality Management System emphasizes continuous improvement, evidence-based decision-making, and rigorous process oversight, enabling systematic detection, analysis, and resolution of quality issues. The internally embedded deviation management, risk detection, incident management, and CAPA processes ensure end-to-end quality monitoring in all operations.

How does Wemedoo support sponsors, CROs, and investigators during audits and inspections?

Wemedoo supports audit readiness through its compliant clinical research information system designed to meet 21 CFR Part 11, HIPAA, GDPR, and ICH GCP requirements. This ensures regulators can easily verify data integrity, system controls, and workflow compliance during inspections. Real-time oversight, complete data traceability across modules, and robust quality documentation built into the QMS further strengthen audit preparedness and facilitate transparent collaboration with auditors.

What is Wemedoo Audit History?

Wemedoo maintains a clear and comprehensive audit and inspection history as part of its ISO aligned Quality Management System. The company is fully committed to audit readiness, regulatory transparency, and continuous quality improvement, ensuring that documentation, processes, and validation evidence are always organized, current, and inspection ready. Wemedoo has undergone external inspections by both the FDA and Swissmedic, successfully passing with no findings, demonstrating that its quality practices, validation approach, and operational controls fully meet and even surpass regulatory expectations.