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MaxisIT’s cloud-based Risk-based Monitoring (RBM) platform integrated with our CTRenaissance product suite offers an innovative Centralized Monitoring / Risk Based Monitoring solution for the Life Sciences Industry. The platform is based on TransCelerateʼs Risk based Monitoring methodology and is backed by MaxisIT’s knowledgeable and experienced technical/medical/advisory board facilitating a smooth and successful implementation of our solution across various therapeutic areas. The methodology uses Quality Risk Management as a foundation in ensuring subject safety and data quality.

ADVANTAGES

  • Smarter analytics and reporting.
  • Ability to function as the single point of contact for understanding, monitoring, and mitigating risks.
  • Employs out-of-the-box integrated RBM workflows and alerts that can be quickly configured to access desired data.
  • Can access any desired external data source using our Integration-as-a-Service (IaaS) component.
  • End-to-end risk mitigation workflow engine.

KEY FEATURES

The MaxisIT RBM solution contains the following key features:

  • Risk Assessment Categorization Tool (RACT): A configurable RACT allows a user to add, delete, and update risk categories or define risks within a category.
  • Integrated Risk Management Plan (IQRMP): A configurable IQRMP allows a user to specify the actions that need to be performed in order to mitigate risks.
  • Integration as a Service: Our RBM solution can link to a set of Application Programming Interfaces (APIs) from multiple external third-party systems for risk assessment and mitigation.
  • Customized Source Data Validation engine: Allows customized rule setup to source data, enabling the validation of required data fields.
  • Advanced Analytics and Reporting: A complete set of Analytics & Reporting capabilities consisting reports and visualizations that can generate dashboards for Risk Monitoring.

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CUSTOMER SPEAK

“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

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