Neozene
Neozene is a contract research organization with over 25 years of industry experience, focusing on clinical, quality assurance, regulatory, and healthcare fields. It aims to advance medicine through innovative solutions, supporting research and care delivery across the U.S. with a mission to disrupt the status quo in contract research.
Industries
Nr. of Employees
medium (51-250)
Services
Consulting and operational services for planning and executing clinical development programs, combining protocol support, project management and operational staffing across study phases.
Monitoring services to verify protocol compliance, ensure data quality and oversee participant safety using on-site and remote monitoring approaches.
Placement and deployment of nursing and clinical staff to support patient care and research site operations.
Development and implementation of quality management systems and quality programs to meet regulatory and operational requirements.
Advisory services for regulatory strategy, interactions with regulatory authorities and preparation for regulatory approvals and licensure.
Project management for targeted initiatives including process improvement, compliance remediation and commercialization readiness projects.
Consulting and operational services for planning and executing clinical development programs, combining protocol support, project management and operational staffing across study phases.
Monitoring services to verify protocol compliance, ensure data quality and oversee participant safety using on-site and remote monitoring approaches.
Placement and deployment of nursing and clinical staff to support patient care and research site operations.
Development and implementation of quality management systems and quality programs to meet regulatory and operational requirements.
Advisory services for regulatory strategy, interactions with regulatory authorities and preparation for regulatory approvals and licensure.
Project management for targeted initiatives including process improvement, compliance remediation and commercialization readiness projects.
Expertise Areas
- Clinical trial management
- Clinical monitoring
- Clinical staffing and site support
- Quality management systems and QA
Key Technologies
- Clinical trial monitoring methodologies
- Quality management system frameworks (QMS)
- Regulatory submission workflows
- Human factors engineering (HFE) methodologies
News & Updates
Apple and Zimmer Biomet collaborate on a large clinical study using Apple Watch and iPhone app to improve recovery and costs in hip and knee replacements.
Clovis Oncology’s PARP inhibitor Rubraca shows potential in treating BRCA- or PALB2-mutated pancreatic cancer, with early promising data.
Insulet’s study of its tubeless Omnipod insulin management system in young children with Type 1 diabetes shows improved blood glucose control.
Analysts express caution on Moderna’s COVID-19 vaccine prospects due to competition and regulatory challenges.
Apple and Zimmer Biomet collaborate on a large clinical study using Apple Watch and iPhone app to improve recovery and costs in hip and knee replacements.
Clovis Oncology’s PARP inhibitor Rubraca shows potential in treating BRCA- or PALB2-mutated pancreatic cancer, with early promising data.
Insulet’s study of its tubeless Omnipod insulin management system in young children with Type 1 diabetes shows improved blood glucose control.
Analysts express caution on Moderna’s COVID-19 vaccine prospects due to competition and regulatory challenges.