Cyntegrity Rolls out SaaS Application to Help Pharma Organizations Bring Regulatory Guidance into Practice
Frankfur-Cyntegrity, a German provider of proprietary Risk-based Monitoring (RBM) cloud services for the Life Sciences industry, today announced the roll out of “@RACT-Pro”-simple and affordable risk assessment and mitigation tool. There is even a free version. This online SaaS (software as a service) application is specifically designed for mid-market clinical enterprises and biotech companies transiting to risk-oriented processes in response to the latest revision of the Good Clinical Practice guideline ICH E6 (R2).
“We are thrilled to help the clinical research community bringing high-level regulatory guidance into daily practice. Nowadays, in pharma simple answers matter. How to generate basic documents like Risk Management plan or Risk Register fast and easy? How to leverage the efficiency of project management with artificial intelligence? All areas of clinical trial management will benefit from risk information to make sound decisions. We are happy now to make it affordable for all. There is no excuse any more not to conduct the proper risk management in a clinical trial.”, says Dr. Artem Andrianov, CEO of Cyntegrity.
@RACT-Pro - the Key to Clinical Success and Regulatory Compliance
@RACT-Pro offers all essential features for three main regulatory-required activities
- Creation of Risk Identification, Risk Assessment, and Risk Mitigation plan for a clinical trial involving all stakeholders.
- Central management of critical data and critical processes
- Export of ready-to-use risk register, risk management plan or Key Risk Indicator list from the system for further perusal
In other words, it introduces to novice users the basics of collaborative Risk-based Quality Management.
“Once clinical monitors and others involved in a clinical study start working with @RACT-Pro they will understand the true value of this service. The built-in intelligence and self-learning aspects of the platform, will help them save time and effort when setting up the next study”, explains Cyntegrity’s Chief Scientific Officer, Dr. Johann Proeve.
Cyntegrity is a leading RBM technology provider, which offers specialized cloud and SaaS solutions for the efficient Risk-based Quality Management and Monitoring in clinical trials. Cyntegrity’s mission is to offer high-quality analytics that are more predictive than retrospective, which have the ability to integrate the knowledge from previous trials with contextual, real-world data to reduce patient-risk and to optimize clinical operations. For more information, visit https://cyntegrity.com.
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