MARS Automation Platform for Biopharma
oleh Quartica, Inc.
Automated Content Generation & Analytics for Biopharma Clinical, Safety, Regulatory & Other domains
To stay competitive in the post-covid changing market with shorter R&D cycle times, a key differentiator for biopharma companies is the ability to create content (documents, reports, scorecards, schedules, signals, summaries, letters, etc.) with insights and evidence from multiple data sources quickly and with quality and regulatory compliance. MARS enables biopharma companies to bring the ad-hoc facets of content generation and analytics across the biopharma value chain using AI.
MARS improves the information flow enabling new content creation business models which can provide better patient engagement and experience to biopharma companies. MARS enterprise content generation can help improve the end-to-end process from information flow, content creation, insights to the distribution and tracking of compliance metrics.
Key Features:
- Automated text narratives, data analysis with tables and figures in compliance with regulations (ICH, GVP and others)
- Automated analysis of clinical & safety data with data insights and trends
- Automated document generation from multiple libraries and data
sources
- Automated abbreviations list and references list including shared and re-usable lists
- Collaborative authoring and review with AI as co-author
- Content tense adjustment and harmonization
- Artificial Intelligence / Machine Learning capabilities
- Out of the box and Customizable API's
- Configurable workflows, templates, notifications and task management
- 21 CFR Part 11 compliant with audit trails with blinded and unblinded user profiles
MARS Key Use Cases across the biopharma value chain:
- Pharmacovigilance (Safety)
- Aggregate Reports
- Safety Data Analysis
- Signal Management
- Risk Management
- SDEA, QPPV & Others
- Clinical and Medical Affairs
- Clinical Protocols
- Clinical Study Reports
- Investigator Letters (DILs)
- Standard Query Responses
- Others
- Regulatory Affairs
- Regulatory eCTD
- Regulatory Intelligence
- Labeling
- CMC Change Assessments
- Others
- Manufacturing & Quality
- Annual Product Review
- Training & Upskilling
- Protocol Verification
- Quality Documents
- Others