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Quality is the backbone
of clinical trials.

Trusting your RTSM provider to deliver exceptional quality and performance is critical to protect patient safety and study integrity. At 4G Clinical, we’ve implemented robust quality systems, security and compliance into the fabric of everything we do.

Infrastructure that protects study integrity and patient safety.

Our approach to systems and security offers you confidence that your trial is safe and secure.

  • Systems

    Protecting the Blind

    Prancer RTSM® supports any combination of blinding, including having both blinded and unblinded users at each site. We also offer emergency unblinding for investigators as well as safety unblinding by your pharmacovigilance team.

    Integrations as Microservices

    Our approach enables us to add new integrations and update existing ones without revalidation of Prancer RTSM®. Learn more about how our integrations microservices enable higher quality and more efficient error handling.

    Our Approach to Integrations
  • Security

    Cloud-based Architecture

    4G Clinical leverages cloud infrastructure providers such as Amazon Web Services (AWS) to provide unparalleled levels of security to our customers. We offer full traceability of system changes, alongside comprehensive disaster recovery plans (including supplemental cross-regional plans) in the case of a major disaster.

    Learn More About Our Partnerships

    Kubernetes (k8s)

    4G Clinical offers advanced study continuity support by leveraging kubernetes (k8s). This allows us to update or replace servers and enable dynamic scaling of your application to highs and lows in resource requirements.

  • Compliance

    Ensuring Data Privacy

    4G Clinical is registered with the EU-US Privacy Shield framework and maintains compliance with the regulations outlined in the EU General Data Projection Regulation (GDPR, EU 2016/679) Directive, the California Consumer Privacy Act (CCPA) and General Data Protection Law (LGPD).

    Robust Quality Framework

    4G Clinical has an established Quality Management framework to comply with the intent of 21 CFR Part 820 Quality System Regulation and ISO standards. Elements of the Quality System include Procedures, Training, Change Management, Supplier Management, Corrective and Preventive Action, and Auditing Program. 

Protecting the Blind

Prancer RTSM® supports any combination of blinding, including having both blinded and unblinded users at each site. We also offer emergency unblinding for investigators as well as safety unblinding by your pharmacovigilance team.

Integrations as Microservices

Our approach enables us to add new integrations and update existing ones without revalidation of Prancer RTSM®. Learn more about how our integrations microservices enable higher quality and more efficient error handling.

Our Approach to Integrations

Cloud-based Architecture

4G Clinical leverages cloud infrastructure providers such as Amazon Web Services (AWS) to provide unparalleled levels of security to our customers. We offer full traceability of system changes, alongside comprehensive disaster recovery plans (including supplemental cross-regional plans) in the case of a major disaster.

Learn More About Our Partnerships

Kubernetes (k8s)

4G Clinical offers advanced study continuity support by leveraging kubernetes (k8s). This allows us to update or replace servers and enable dynamic scaling of your application to highs and lows in resource requirements.

Ensuring Data Privacy

4G Clinical is registered with the EU-US Privacy Shield framework and maintains compliance with the regulations outlined in the EU General Data Projection Regulation (GDPR, EU 2016/679) Directive, the California Consumer Privacy Act (CCPA) and General Data Protection Law (LGPD).

Robust Quality Framework

4G Clinical has an established Quality Management framework to comply with the intent of 21 CFR Part 820 Quality System Regulation and ISO standards. Elements of the Quality System include Procedures, Training, Change Management, Supplier Management, Corrective and Preventive Action, and Auditing Program. 

The Why Behind Quality

Can quality and innovation truly coexist? We believe they can.

Robust validation and change control processes.

4G Clinical performs validation on the product infrastructure, core products, and projects deployed for our customers. Validation ensures a high degree of assurance that all aspects of our products and projects meet predetermined requirements, specifications, and quality attributes. 4G Clinical ensures the infrastructure, core products, and projects are maintained in a validated state through a strict change control process.

open-quote'How much validation is enough?' is a question that all sponsors struggle with. By focusing on those areas that introduce the highest risk to the study; particularly those that are not sufficiently covered by the vendor - should help sponsors hone in to exactly what they need to do to complete the validation of their RTSM.close-quote

Laura Araujo, Vice President, Quality, 4G Clinical

Modern Technologies in Clinical Trials