SALVUS COMPLAINT TO 10+ PHARMACEUTICAL REGULATORY AGENCIES
Achieve more with less
Crypta streamlines literature screening by offering an intelligent and efficient method for handling literature monitoring, identifying pertinent cases, and submitting them to your safety database. Enhance compliance and save valuable time with Crypta
Automated Import of Literature Articles
Crypta simplifies the process of data acquisition by automatically importing relevant literature articles. This feature ensures that the latest research and publications are always at the users' fingertips, eliminating the need for manual data collection.
Automated Translation of Abstracts and Full-Text Articles
With multilingual support, Crypta offers automated translation of both abstracts and full-text articles, breaking down language barriers and making global literature accessible to users. This feature ensures inclusivity and expands the scope of literature reviews.
Comprehensive Literature Review Support
Crypta supports both Global and Local Literature Reviews, providing users with a robust framework for comprehensive data analysis. The platform's flexibility allows for tailored reviews that meet the specific needs of different regulatory environments.
E2B(R2) & E2B(R3) XML Generation
Crypta enables automated generation of E2B(R2) and E2B(R3) XML files directly from literature articles containing valid ICSR data. Our system extracts and structures case information—including patient details, suspect drugs, adverse events, and outcomes—into XML formats that fully comply with ICH standards for global safety reporting. This ensures faster, audit-ready submissions to regulatory authorities such as the FDA, EMA, and PMDA.
Automated ICSR Detection
The platform excels in identifying Individual Case Safety Reports (ICSRs) within vast datasets, significantly reducing the time required for safety monitoring. Crypta's AI-driven detection ensures high accuracy and relevance, minimizing the risk of missing critical safety data.
Automated Highlighting of Key Details
Crypta automatically highlights essential details such as product names, adverse events, patient information, and reporter details within articles. These intelligent highlighting speeds up the review process and enhances the accuracy of data extraction.
Highly Customizable Workflows
Recognizing the diverse requirements of its users, Crypta offers highly customizable workflows. These workflows can be tailored to fit specific organizational needs, ensuring seamless integration into existing processes.
Audit Trail and 21 CFR Part 11 Compliance
Compliance with regulatory standards is a cornerstone of Crypta's design. The platform includes a comprehensive audit trail feature and adheres to 21 CFR Part 11 regulations, ensuring that all actions are traceable and that the platform meets the stringent requirements of the pharmaceutical industry.
Auto-Generation of Summary of Analysis
Crypta's Generative AI capability allows for the automatic generation of comprehensive summaries. These summaries provide concise and insightful overviews of complex datasets, enabling quicker decision-making and reporting.
Automated Duplicate Check
The platform includes an advanced duplicate detection feature, which automatically identifies and flags duplicate entries, ensuring data integrity and reducing redundancy in literature reviews.
Multilingual Support
Crypta's multilingual capabilities extend beyond translation, providing full platform support in multiple languages. This feature is critical for global teams and ensures that the platform can be effectively utilized in diverse linguistic environments.
Integrated MedDRA Coding
Crypta is seamlessly integrated with the latest version of MedDRA (Medical Dictionary for Regulatory Activities), enabling real-time mapping of adverse events and indications to appropriate MedDRA Preferred Terms (PTs) and codes. This ensures consistent terminology usage across ICSRs, signal detection reports, and aggregate analysis, improving data quality, regulatory compliance, and pharmacovigilance signal tracking.
The Outcome
Efficient Review
Cut down the necessity for extensive review of literature citations and abstracts by up to 50%, utilizing machine-assisted learning to boost accuracy.
Productivity Increase
Integrated search and configurable literature screening workflows delivering up to 70% productivity gains powered by AI
INTEGRATED PLATFORM
A platform for guaranteed compliance
With ICH, EMA, FDA, EU GMP Annex 11, US FDA 21 CFR part 11, and EMA’s Good Pharmacovigilance Practice (GVP) guidelines, Crypta is compliant with many regulations and directives from around the world.
