In the everchanging clinical trial landscape, a sustainable quality management system is imperative. The Pharmaceutical Quality for the 21st Century Initiative announced by the FDA was developed to create an efficient, flexible, and agile pharmaceutical manufacturing sector that is associated with the development of reliable high-quality drug products. The International Conference on Harmonization (ICH) provided guidance in 2005, the Q8 (Pharmaceutical Development) and Q9 (Quality Risk Management) to ensure a quality-by-design framework. A rigorous and predictable system will help in the quality management of clinical trials.
Navitas Life Sciences’ qualityREADY® , enables the automation of processes including Deviation, Investigations, Incidents, Market Complaint, Audits, Out-of-Specification (OOS) and Out-of-Trends (OOT), CAPA, and Change Management to name but a few. Other business process systems (ERP, LIMS, DMS, and CRM) can also be integrated to enable well-orchestrated quality management activities. In addition, country specific nuances can also been addressed and needs met.
Navitas Life Sciences’ qualityREADY® Analytics
qualityREADY® Analytics is a robust intelligence system which leverages fully integrated quality data to provide deeper insights on critical quality metrics.
The tactical concept of qualityREADY® is to ensure a proactive and flexible framework that will help in holistic quality management across the clinical trial process. It was developed to ensure data reliability that can be used by sponsors, sites, clinicians, and partners to make informed decisions.
Let’s take a look at some of the benefits of using qualityREADY®
Better Managed Clinical Trial Sites: qualityREADY® provides strategic oversight to help senior management review the overall health of quality processes and make informed decisions. This helps to better streamline processes and ensures appropriate focus on critical issues.
A pharmaceutical company can handle clinical trial data well if there is a single software deployed across the system to rapidly identify issues and prevent a negative trend. This allows sites to be better managed with precise intake of information and enhanced categorization.
Enhanced Clinical Trial Processes using qualityREADY®
- Precise capture of information and event categorization
- High-risk issues detected faster
- New issues and problems identified, leading to proactive steps
- Insights and analysis available for real-time proactive correction
Audit Ready for Regulatory Authorities: qualityREADY® provides a standard framework for evaluation by regulatory authorities, aiding a smooth audit process. The quality assurance team will be informed and able to demonstrate the quality KPIs/processes to health agencies during inspections.
It is imperative to use the right methods and systems to ensure that high performance is delivered, which, in turn, decreases the inspection frequency from health agencies.
Enhanced Patient Safety: The foundation of this system lies in the structured event assessment which allows early identification of risk and better patient safety and engagement. The closer and easier scrutiny of any effects of treatment help in better managing patient needs during clinical trials.
The dashboard also provides better visibility of patient history and the symptoms that are currently being experienced, allowing better management of treatment.
Smart Decision Making for Efficient Trials for Sponsors: qualityREADY® uses a smart intelligence system that provides comprehensive data management. This allows better sponsor oversight, aiding quality assurance by identifying gaps in processes and helping to optimize process steps
How qualityREADY® Benefits Sponsor Oversight
- Standardized information uptake that can be visualized on a simple dashboard
- Rapid identification of potential areas of risk
- Improved decision making based on emerging issues identified
- Allows adjustments of metrics and targets to enhance performance
- Possibility to view the spectrum of the value chain
- Lower study delays and better study optimization
Gain from the qualityREADY®’s Technical Capabilities
qualityREADY® aims to move clinical trial data management from the state of manual entry, with multiple data stored in silos and across sites, to a future state of robust intelligent processes that will help improve the quality of data provided and reduce cycle times.
Key Technical Features of qualityREADY®
- Implementation of pre-built analytics framework for handling quality metrics on: Deviation | CAPA | Change Control Market Complaints | OSS/OTT | Audi
- Seamless integration with participating business systems (QMS, ERP, and LIMS) from industry leading providers including: TrackWise | SAP | Labware
- An analytics platform that combines technology, domain, and industry best practices
- Built using best-in-class analytics tools, compliant with leading standards including ISO, 21 CFR Part 11, and GxP
Case Study: Learn how a Global Pharmaceutical company reduced product quality issues by 20% using qualityREADY®
A leading global pharmaceutical company headquartered in India with capabilities across the pharmaceutical value chain including formulations, active ingredients, wellness, and animal health, required support for collating data for quarterly review meetings and audits. They wanted to implement an advanced analytics solution that was efficient and provided high-quality data.
qualityREADY® was implemented to provide deep insights into critical quality metrics, allowing proactive decisions for improved quality outcomes.
The qualityREADY® approach improves effectiveness and reduces quality issues, providing pertinent information related to clinical trial processes in a constantly updated data pool. The analytics help detect any deviations and are the linchpin of enhancing the quality management process.