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WiseCLIN: Your Risk-Based Oversight System (RBOS)

Translating a culture of risk to clinical research

WiseCLIN, powered by Qlarix‘s vision, centralizes oversight across clinical programs and trials, integrating strategic risk management to identify critical areas that demand attention. By focusing on these key risk areas, WiseCLIN enables organizations to establish a tailored oversight strategy that optimizes resources and enhances trial quality.

Through continuous risk assessments, WiseCLIN evaluates the effectiveness of implemented control measures, ensuring they adapt to evolving trial dynamics. Aligned with industry best practices, including TransCelerate and industry advancements in oversight and risk management, WiseCLIN facilitates a proactive approach that drives compliance, improves trial outcomes, and supports informed decision-making across all phases of clinical research.

To complement WiseCLIN’s cutting-edge technology, Qlarix collaborates closely with its sister company, Pharmity, which provides consulting and training services tailored to meet the unique needs of our clients. Pharmity brings decades of experience in clinical quality management, offering a wealth of expertise to ensure your team is equipped with the knowledge and strategies needed to maximize the value of WiseCLIN. Together, Qlarix and Pharmity deliver a comprehensive solution that combines innovative technology with deep industry know-how, empowering organizations to achieve excellence in clinical trial oversight.

Key Features

Aligned workflows with ICH E6 and E8 to enhance the integrity and quality of clinical trials.

Built on a robust RBQM methodology, targets critical areas, optimizes resources, and ensures compliance through efficient, data-driven processes.

Tailors your project management strategies to specific contexts: organizational, program, study, and site.

Collaborative boards designed to foster teamwork and communication. Integrated audit trail that includes meetup functionality to register all participants involved in each meeting, ensuring comprehensive documentation and accountability

Configurable Critical to Quality (CtQ) Factors Schema, designed upon Clinical Trial Transformation Initiative (CTTI) recommendations, to uphold trial standards

Configurable Risk Scoring Model to align with your organization’s tolerance levels

Action management module. Defines, assigns, and tracks risk control actions, ensuring team alignment and clear ownership through integrated RACI matrices

Continuous, documented Risk Assessments for clear oversight

Provides advanced analytics to justify your risk decisions, offering comprehensive data support through intuitive dashboards. Every decision is backed by robust, real-time data, enabling you to make informed and resilient choices

Map Your Risk Control Actions to Cost-Effective Strategies

Easily share critical risk information with all stakeholders. Enhances collaboration and ensures everyone is aligned on risk priorities and risk control strategies, improving overall trial outcomes

Ensures Data Integrity and Reliability – Move Beyond Spreadsheets

Leverages AI to assimilate your organization’s accumulated lessons, harnessing this intelligence to refine and enhance future risk management strategies effectively

What Makes WiseCLIN Stand Out? 

Unlike other tools, WiseCLIN offers a comprehensive oversight solution tailored for clinical trials, developed by experts who the challenges of modern trials and are dedicated to helping you achieve success.