Self-Service Clinical Insight Solutions

Decisions Empowered

Data, Analytics, Insight…Faster

Self-Service Clinical Insight Solutions

Decisions Empowered

Data, Analytics, Insight…Faster

FEEL EMPOWERED BY GAINING VISUAL CONTROL

Optimize key performance indicators and performance areas within clinical R&D via fully interactive clinical insight solutions.

All integrated data is available to Clinicians, Clinical Data Reviewers, Clinical Operations, Clinical Biostatistics, Senior Management, and Analytics Consumer end users in Clinical R&D processes via a secured cloud-based offering.

EMPOWERING CLINICAL REVIEWERS, CLINICAL OPERATIONS, BIOSTATISTICS, AND SENIOR MANAGEMENT WITHIN CLINICAL R&D

Leverage clinical insight solutions to get visual and self-service control over clinical R&D insight via completely interactive and role-based dashboards and visualization. Completely interactive, user-friendly, clinical insight solutions that can help support your ability to make faster and informed decisions in the most self-services manner across. Efficient, faster time-to-value, reliable, and allows end users to focus on the business value of timely decisions. It is all in cloud, secured and performance enabled!

CENTRAL STATISTICAL MONITORING

Overview
An integral part of MaxisIT’s Integrated Clinical Development Platform Cloud, CSM provides comprehensive, interactive, and scenario-based statistical reports at a specific data, study, site, patient, and visit-level to the portfolio level.

Features
CSM enables greater flexibility and ease for clinicians, biostatisticians, as well as for clinical operations teams to detect significant clinical and / or operational performance insight. Delivers complete authenticity and reliability scan of data during trial execution, as well as data within repository before regulatory submission

Key Differentiators
Built-in advanced and robust statistical algorithm and made available in a pervasive & invisible manner. A Comprehensive library of pre-configured standard statistical matrices; statistical reports configurator for ad hoc or additional monitoring needs; linked / scenario-based monitoring reports in side-by-side review panels; auto-refresh as underlined data changes, alerts, role-based controls, version controls, interactive dashboards; integrated with data repository and integratable with additional data sources.

User Benefits
CSM delivers faster insights into clinically significant events, evolving safety scenarios, trial site performance, and data quality. No programming needed; completely self-services.

CLINICAL OPERATIONS PERFORMANCE MONITORING

Overview
Clinical Operations Performance Monitoring (COPM) delivers role-based clinical operations dashboards with precise insights that allow monitoring clinical operations performance, tracking planned vs. actual scenarios and detecting any potential fraud events, measuring site performance, monitoring protocol deviations, tracking enrollment, data quality, and many other standard clinical operations performance matrices that are pre-configured and made available.

Features
COPM’s interactive matrices are linked in a scenario-based fashion allowing an integrated qualitative and quantitative performance of clinical operations from top-down level with abilities to drill-down, filter, perform pool/unpool analysis across studies or sites or visits or events, storytelling etc.

Key Differentiators
Comprehensive library of pre-configured standard clinical operations matrices; reports configurator for ad hoc or additional monitoring needs; linked / scenario-based monitoring reports in  side-by-side review panels; auto-refresh as underlined data changes, alerts, role-based controls, version controls, interactive dashboards; integrated with data repository and integratable with additional data sources.

User Benefits
Enables end users to monitor, assess, decide and take actions on a timely basis to manage clinical operations on time, within budget, and risk-free. No programming needed; completely self-services.

RISK-BASED MONITORING

Overview
MaxisIT’s cloud-based Risk-based Monitoring (RBM) platform is developed based on TransCelerate methodology; it integrates with our CTRenaissance® product suite as well as industry standard clinical & operational data sources. It offers an innovative centralized monitoring / Risk Based Monitoring solution for the Life Sciences Industry

Features
This complete RBM solution includes completely configurable Risk Assessment Categorization Tool (RACT), Integrated Risk Management Plan (IQRMP), source data validation engine, advance analytics & reporting dashboards, alerts & notifications, thresholds management, role-based access controls, integration services for third-party integrations, and library management for RBM implementation across the portfolio of studies.

Key Differentiators
RBM solution has the ability to function as the single point of contact for understanding, monitoring, and mitigating risks, by employing out-of-the-box integrated RBM workflows.

User Benefits
Completely configurable, integratable, and scalable solution to manage studies with smarter analytics and risk-based / central monitoring. No programming needed; completely self-services.

+ Central Statistical
Monitoring

CENTRAL STATISTICAL MONITORING

Overview
An integral part of MaxisIT’s Integrated Clinical Development Platform Cloud, CSM provides comprehensive, interactive, and scenario-based statistical reports at a specific data, study, site, patient, and visit-level to the portfolio level.

Features
CSM enables greater flexibility and ease for clinicians, biostatisticians, as well as for clinical operations teams to detect significant clinical and / or operational performance insight. Delivers complete authenticity and reliability scan of data during trial execution, as well as data within repository before regulatory submission

Key Differentiators
Built-in advanced and robust statistical algorithm and made available in a pervasive & invisible manner. A Comprehensive library of pre-configured standard statistical matrices; statistical reports configurator for ad hoc or additional monitoring needs; linked / scenario-based monitoring reports in side-by-side review panels; auto-refresh as underlined data changes, alerts, role-based controls, version controls, interactive dashboards; integrated with data repository and integratable with additional data sources.

User Benefits
CSM delivers faster insights into clinically significant events, evolving safety scenarios, trial site performance, and data quality. No programming needed; completely self-services.

+ Clinical Operations
Performance Monitoring

CLINICAL OPERATIONS PERFORMANCE MONITORING

Overview
Clinical Operations Performance Monitoring (COPM) delivers role-based clinical operations dashboards with precise insights that allow monitoring clinical operations performance, tracking planned vs. actual scenarios and detecting any potential fraud events, measuring site performance, monitoring protocol deviations, tracking enrollment, data quality, and many other standard clinical operations performance matrices that are pre-configured and made available.

Features
COPM’s interactive matrices are linked in a scenario-based fashion allowing an integrated qualitative and quantitative performance of clinical operations from top-down level with abilities to drill-down, filter, perform pool/unpool analysis across studies or sites or visits or events, storytelling etc.

Key Differentiators
Comprehensive library of pre-configured standard clinical operations matrices; reports configurator for ad hoc or additional monitoring needs; linked / scenario-based monitoring reports in  side-by-side review panels; auto-refresh as underlined data changes, alerts, role-based controls, version controls, interactive dashboards; integrated with data repository and integratable with additional data sources.

User Benefits
Enables end users to monitor, assess, decide and take actions on a timely basis to manage clinical operations on time, within budget, and risk-free. No programming needed; completely self-services.

+ Risk Based
Monitoring

RISK-BASED MONITORING

Overview
MaxisIT’s cloud-based Risk-based Monitoring (RBM) platform is developed based on TransCelerate methodology; it integrates with our CTRenaissance® product suite as well as industry standard clinical & operational data sources. It offers an innovative centralized monitoring / Risk Based Monitoring solution for the Life Sciences Industry

Features
This complete RBM solution includes completely configurable Risk Assessment Categorization Tool (RACT), Integrated Risk Management Plan (IQRMP), source data validation engine, advance analytics & reporting dashboards, alerts & notifications, thresholds management, role-based access controls, integration services for third-party integrations, and library management for RBM implementation across the portfolio of studies.

Key Differentiators
RBM solution has the ability to function as the single point of contact for understanding, monitoring, and mitigating risks, by employing out-of-the-box integrated RBM workflows.

User Benefits
Completely configurable, integratable, and scalable solution to manage studies with smarter analytics and risk-based / central monitoring. No programming needed; completely self-services.

Demonstrated 40% time and 50% cost savings

EXPERIENCE THE MAXISIT® DIFFERENCE

VOICE OF CUSTOMERS

“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
Multi-billion dollar pharma organization focused into rare disease
"Managing trials cost-effectively, and timely have been the biggest priorities in small biotech organizations with potential to grow; MaxisIT’s Integrated Platform just delivered that by allowing us to get faster access to data via clinical data repository, and role-based & self-service A&R platform to keep track of our clinical, operational, and administrative performance across the portfolio of oncology trials.”
Sr. Director, Project and Clinical Data Management
Oncology Biotech Company
“Implementation of MaxisIT’s clinical data repository enabled us easier, and faster access to our outsourced trials’ data in the most user-friendly manner, which improved our ability to respond to data quality issues, and conduct clinical data review in timely manner.”
Executive Director and Senior Physician Project Leader
Neurosciences Focused Business Subsidiary of one of the top 10 Pharmaceutical Companies
“Right combination of technology, process, and qualified people delivered via MaxisIT partnership enabled us to achieve above 50% reduction in protocol cycle time across the portfolio of trials, and also establish clear visibility across the trial performance.”
Head, Clinical Data Management
A Multi-billion Medical device company