Streamlining Biotech Data Compliance and Management with Certara's Phoenix Hosted
A biotechnological company has been engaged in creating innovative drug development processes that require precise and compliant data management solutions for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic (TK) modeling. The primary liaison for Certara at the company, a senior scientist with over two decades of experience using Phoenix WinNonlin, has played a pivotal role in transitioning the company to a more integrated and compliant data management system. His expertise has been crucial in navigating the complexities involved in implementing a new system.
Challenges
The company faced challenges in effectively managing their PK data analysis processes, particularly in complying with the stringent 21 CFR Part 11 standards for electronic records and signatures. Their existing systems were inadequate to handle the complex and extensive data management needs, including maintaining compliance with audit trails and efficiently supporting both regulated and non-regulated studies.
Initially, they considered implementing an on-site server solution to retain control over their data and infrastructure. However, the internal IT team was concerned that managing an in-house server for Phoenix software would overextend their resources, which were critical for other IT tasks.
The necessity for a solution that could offer high availability, robust data integrity, and compliance without overloading the existing IT infrastructure became apparent. This need was especially urgent as the company moved toward more electronic and paper-free systems for their analyses, which involved intricate data manipulations and strict compliance with audit trails.
Solution Provided by Phoenix Hosted
Phoenix Hosted provides a comprehensive solution tailored to meet the team’s specific needs. The key components of the solution include:
- Comprehensive Data Management: Phoenix Hosted enables the research group to centralize their data storage and management, ensuring that all data, regardless of the study type, is easily accessible in one root folder location. This system supports both GxP and non-GxP studies.
- Regulatory Compliance and Audit Readiness: The hosted solution comes with built-in compliance features for 21 CFR Part 11, which are critical for the company’s transition to a paperless and electronic system. This not only streamlines the audit processes but also significantly reduces the risk of compliance-related issues.
- Use of PK Submit Plugin: The integration of the PK Submit plugin represents a strategic enhancement. This plugin reduces the time and complexity involved in preparing and analyzing PK datasets, and streamlines processes in regulatory submissions.
- Scalability and Support: Phoenix Hosted offers scalability that allows the company to manage data across different study sizes and complexities without significant additional investments in IT infrastructure.
- Expert Support from Certara: The support from Certara’s experts was key to successfully implementing Phoenix Hosted. Regular touchpoints with the Customer Success Management (CSM) team allowed for detailed discussions and feedback on the solution, ensuring that all specific needs and challenges were addressed promptly and effectively.
The implementation of Phoenix Hosted showcased a strategic alignment of technology with business needs. It provided the necessary tools to enhance their data analysis capabilities while ensuring compliance with regulatory standards. This case study exemplifies how tailored IT solutions like Phoenix Hosted can transform the operational landscape of research and development firms, enabling them to focus more on innovation and less on administrative constraints.
