Katalyst CRO Tech Stack
Clinical research and regulatory operations for pharma and biotech
Katalyst CRO operates an end-to-end contract research platform for pharmaceutical, biotech, and medical device companies, handling pre-clinical studies through Phase IV trials, regulatory submissions, and quality compliance. The tech stack reveals a dual operational model: SAS, Oracle Clinical, and Medidata Rave for clinical data and biostatistics; SAP ERP, SAP MES, and Rockwell Automation for manufacturing and process control. Heavy hiring in engineering (300+) and manufacturing (120+) alongside data (104+) signals sustained investment in internal tooling and compliance automation rather than pure consulting resourcing. Active adoption of Veeva Vault points toward modernizing document and regulatory content management across a traditionally legacy-heavy function.
Tech Stack 200 technologies
What Katalyst CRO Is Building
◆Challenges
- Ensuring fda compliance
- Compliance with regulatory and quality standards
- Maintaining system compliance
- Inspection readiness
- Improving repair efficiency
- Compliance gaps
- Increasing efficiency of statistical programming group
- Compliance with fda regulations
- Continuous improvement of validation processes
- Managing change controls
▲Active Projects
- Regulatory submissions
- Design verification and validation
- Sdtm dataset development
- Test method development and validation
- Equipment qualification protocols
- Data management plan development
- Adjudication of video-endoscopies
- Qol initiatives regulatory strategy
- Manufacturing process implementation
- Process validation for new manufacturing processes
Hiring Activity
Department
Seniority
Notable leadership hires: Medical Director, Validation Lead, Program Director, GxP Test Lead