Diverse services to match your needs
Clinical Development Operations
Build operational infrastructure and governance
Develop process, tools, and templates
End to end clinical trial management phase I-IV
Documentation development and maintenance including protocols, ICFs, study plans, study reports, CRF design
TMF oversight and quality management
Service provider contracting and management
Clinical systems evaluation, specifications, configuration, and implementation
Medical Affairs Operations
Scientific communications, publication planning and execution
Content and materials creation – scientific and corporate presentations, field medical and educational materials
Evidence generation strategy and knowledge gap analysis
Study design and management – RWE, interventional, non-interventional, registries, post-authorization safety studies
Investigator-sponsored study oversight
Managed access program management
Congress, scientific meeting and event support, planning, booth, and logistics
Advisory board planning, presentations, and logistics
Field medical support
Clinical Process, Training, and Compliance
Governance gap analysis
SOP and policy development
Risk-based quality management
Inspection readiness planning
Root cause analysis and CAPA management
Compliance metrics
Develop role-based curricula and training plans
Develop training materials
Deliver training presentations, videos, in person
Patient Engagement
Develop educational materials and tools
Develop patient-centric communications
Collect and process patient insights for trial design, operations, enrollment, and retention
Collaborate with patient advocacy groups
