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

MARS Automation Platform for Biopharma

by Quartica, Inc.