Anovo
Consulting firm providing clinical development and project management services across the biopharmaceutical life cycle. Leadership reports collective experience managing Phase I–IV clinical trials with emphasis on Phase II/III practices, and delivering services including clinical site management, protocol development, monitoring, regulatory submissions, quality assurance, vendor management, and trial document management for pharmaceutical and biotechnology organizations.
Industries
Nr. of Employees
small (1-50)
Anovo
Danville, California, United States, North America
Services
Site identification and selection, budgeting and contracting, subject recruitment, compliance, and retention.
Project plans, resource planning and allocation, and risk assessment and management for clinical programs.
Development of protocol documents, ICF templates, monitoring plans, investigator brochures, TMF support, and committee charters.
RFP process management, contract negotiation, and vendor management services.
On-site and remote monitoring activities including source documentation review, CRF review, data query resolution and interim analyses as requested.
Audit plan design and execution, site and vendor audits, and business process re-engineering and SOP development.
Site identification and selection, budgeting and contracting, subject recruitment, compliance, and retention.
Project plans, resource planning and allocation, and risk assessment and management for clinical programs.
Development of protocol documents, ICF templates, monitoring plans, investigator brochures, TMF support, and committee charters.
RFP process management, contract negotiation, and vendor management services.
On-site and remote monitoring activities including source documentation review, CRF review, data query resolution and interim analyses as requested.
Audit plan design and execution, site and vendor audits, and business process re-engineering and SOP development.
Expertise Areas
- Clinical trial management
- Project management for clinical programs
- Clinical monitoring and risk-based monitoring
- Regulatory submissions and compliance
Key Technologies
- Protocol development
- Risk-based monitoring
- Trial Master File (TMF) management
- Central IRB / Ethics Committee submission processes