Certara.AI

Meeting shrinking submission timelines while innovating faster on limited resources can feel overwhelming. That’s where CoAuthor, our GPT-powered regulatory writing platform, steps in. Designed to address the evolving demands of pharmaceutical companies, CoAuthor transforms the way regulatory teams draft and manage submission dossiers.

Here’s how CoAuthor accelerates your workflows:

• Faster Dossier Drafts: Streamline the creation of submission documents, including Modules 1–5, reducing timelines.
• AI-Powered Automation: Leverage secure, organization-specific GPT models to automate first-draft creation while ensuring compliance.
• Effortless Multitasking: Manage multiple program documents and source data seamlessly within a single, cohesive platform.

With CoAuthor, regulatory writing evolves from a time-consuming bottleneck into a streamlined, efficient process—empowering your team to move faster without compromising quality or security.

Imagine freeing your team from spending over 200 working days per year manually analyzing documents. Certara.AI equips your team with advanced AI capabilities to handle large volumes of unstructured data, allowing pharmaceutical companies to maximize time and resources.

The key benefits:

• Effortless Document Search: Create a single, centralized source for all critical documents.
• Automated Data Extraction: Eliminate tedious manual data transformation and reduce the likelihood of errors.
• User-Friendly Design: Extend AI-powered research and data extraction capabilities to non-technical individuals through intuitive tools.

With Certara.AI, workflows that once took days now take mere minutes, allowing your team to dedicate their time to the innovation that drives better product development outcomes.

Clinical outcomes data is essential for trial design, benchmarking, and market planning. However, managing this data across disparate systems is rife with inefficiencies. Enter CODEX, the fully integrated platform that redefines how clinical outcomes data is accessed, managed, and analyzed.

With CODEX, you can:

• Optimize Data Access: Streamline access to all clinical outcomes data within one secure platform.
• Digitize and Automate: Transition static meta-analyses into dynamic, AI-powered datasets.
• Cross-Reference Effectively: Leverage AI to analyze and draw insights from data across multiple indications and sources.

CODEX reshapes the way pharmaceutical companies approach clinical trial analysis, ensuring teams move beyond traditional datasets to holistic, actionable insights.

Staying ahead in competitive markets demands timely intelligence. Traditional methods of literature aggregation and review often result in static, outdated insights. Signal, powered by Certara.AI, transforms how medical affairs teams track key market trends and therapeutic developments.

With Signal, teams gain the ability to:

• Track Key Trends: Real-time analysis of therapeutic areas, treatments, and opinion leaders.
• Access Timely Updates: Replace stagnant reports with dynamic insights on-demand.
• Ensure Data Accuracy: Eliminate missed data and errors in manually aggregated reports.

By delivering live, accurate market intelligence, Signal Certara.AI enables pharmaceutical teams to make informed strategic decisions that drive better outcomes.

Innovation thrives on trust and security. Certara.AI has earned recognition as a trusted AI partner with a U.S. federal agency, delivering bespoke solutions for unique challenges.

Key capabilities include:

• Secure AI Software: Air-gapped infrastructure ensures complete data isolation and security.
• Custom Private GPTs: Develop private, organization-specific AI models with zero reliance on external APIs.
• Auditable Data Movement: Employ transmitter proxies to enable rigorous monitoring and transparency.

By providing scalable, secure AI solutions, Certara.AI empowers government partners to harness the potential of AI in a controlled and compliant environment.