01 / Life Sciences
Accelerate Discovery with Intelligent Automation
OmegaBlack helps pharmaceutical, biotech, and medical device companies deploy AI across clinical development, pharmacovigilance, and regulatory affairs to compress timelines and reduce costs.
02 / Industry Challenges
What's holding Life Sciences back
Clinical Trial Optimization
Patient recruitment remains the single largest bottleneck in drug development. Identifying eligible patients across fragmented EHR systems, matching complex inclusion/exclusion criteria, and managing site performance consume enormous time and resources.
Adverse Event Detection
Pharmacovigilance teams manually review thousands of case reports, literature articles, and social media signals, creating delays in safety signal detection and increasing the risk of missing critical adverse events.
Regulatory Submission Complexity
Preparing IND, NDA, and BLA submissions requires assembling and cross-referencing hundreds of documents across clinical, nonclinical, and manufacturing data, with strict formatting and content requirements that vary by regulatory authority.
Research Data Silos
Discovery, preclinical, and clinical teams operate on separate platforms with incompatible data models, preventing the cross-functional visibility needed to make faster go/no-go decisions and identify repurposing opportunities.
03 / Our Solutions
AI solutions built for Life Sciences
AI-Assisted Trial Design & Patient Matching
Deploy AI agents that analyze real-world data to optimize protocol design, predict enrollment feasibility, and match eligible patients across health systems to accelerate recruitment and reduce screen failure rates.
- Protocol optimization using historical trial data and real-world evidence
- Automated patient matching against inclusion/exclusion criteria across EHR networks
- Enrollment forecasting with site-level performance predictions
- Reduced screen failure rates through better pre-screening intelligence
Pharmacovigilance Automation
Automate intake, coding, and assessment of individual case safety reports with AI agents that read narrative text, assign MedDRA codes, and surface potential safety signals for medical review.
- Automated ICSR intake and MedDRA coding from structured and unstructured sources
- Signal detection across case databases, literature, and social media
- Causality assessment support with evidence summaries for medical reviewers
- Regulatory reporting timeline compliance with automated deadline tracking
Regulatory Document Generation
Accelerate submission timelines with AI agents that draft Module 2 summaries, generate clinical study reports, and assemble eCTD packages while maintaining regulatory formatting and cross-reference integrity.
- AI-drafted clinical overviews and nonclinical summaries with source citations
- Automated eCTD assembly with hyperlink and cross-reference validation
- Multi-authority formatting support for FDA, EMA, and PMDA submissions
- Version control and audit trails compliant with 21 CFR Part 11
Literature Mining & Evidence Synthesis
Extract structured insights from millions of publications, patents, and conference proceedings to support competitive intelligence, systematic reviews, and evidence-based decision making across therapeutic areas.
- Automated systematic literature review with PRISMA-compliant workflows
- Competitive intelligence dashboards tracking pipeline developments and publications
- Evidence gap analysis across therapeutic areas and indications
- Real-time alerting on new publications relevant to active programs
04 / Compliance
Built for your regulatory environment
05 / FAQ
Common questions
06 / Get Started
Compress Your Development Timeline
Talk to our life sciences team about deploying AI across clinical development, pharmacovigilance, and regulatory operations to bring therapies to market faster.
Response within 24 hours