RBQM_Datasheet_ 23.09.24

Page 1


Risk-Based Quality Management (RBQM)

Monitor and mitigate risks with an integrated RBQM solution

Why Choose RBQM?

Accelerate trial performance and assure compliance with our dedicated RBQM solution that works with our entire product suite and fits all study types and designs from collaborative workflows to detailed reporting,

Benefits

Improve data integrity by evaluating data and processes throughout the trial.

Adapt trial parameters based on real-time data, optimizing outcomes.

Enhance decision-making to improve patient safety, protocol compliance, trial oversight, and site performance.

Streamline trial operations with AI-powered insights into patient outcomes and trial trends.

Increase collaboration with role-based dashboards and integrated workflows.

Risk-Based Quality Management (RBQM)

Key features

Risk-Based Data Review

Monitor risks with customizable key risk indicators (KRI) and quality tolerance limits (QTL). Identify data inconsistencies using business rules, patient profiles, and trial oversight intelligence.

Integrated Workflows

Access single source for monitoring and mitigating risks, utilizing Risk Assessment Categorization Tool (RACT) and Integrated Quality and Risk Management Plan IQRMP).

Fully Configurable

Gain flexibility with completely configurable, interoperable, and scalable solution to meet your specific study requirements.

Self-Service Setup

Launch your studies faster with a modular framework that requires no programing.

Visualized Insights

Customize and secure your study data with role-based dashboards and out-of-the-box data visualizations.

Automated Real-time Results

Take a risk-based monitoring approach to trial management.

Use automated data flows and analytics for real-time data view across your study. AI ensures ongoing monitoring of data patterns, outliers, anomalies, and critical risks. Natural Language Processing (NLP) tools allow to analyze structured/unstructured data.

About MaxisIT

MaxisIT’s purpose-fit and intelligent clinical data analytics platform helps improve clinical trial performance, mitigate risk, and optimize clinical outcomes. We provide a centralized and reliable source of truth for diverse data types from various sources, giving life sciences companies real-time insight to shorten cycle time and increase return on investment. Incorporating an end-to-end clinical data pipeline from intake to visualization, MaxisIT's solutions are powered by AI/ML and metadata-centric approaches. Our impressive portfolio of over 3,300 clinical trials and an unparalleled 100% customer retention rate affirm the quality and reliability of our services.

“Having the highest quality clinical data and related information with efficient analytical tools available at all times is critical to managing our clinical programs and accelerating our innovation; and with MaxisIT’s Integrated Clinical Development Cloud, it was easy to achieve that across the portfolio of studies, and we were able to improve the quality of data and speed of decisions without increasing our support staff.”

Head of Clinical Projects

https://maxisit.com/

510 Thornall Street, Suite 180, Edison, NJ 08837

Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.