Our Services
Local Sponsorship
- Local Sponsorship in Australia and Singapore, when required
- Associated local sponsor regulatory activities
- Associated oversight activities
Clinical Monitoring and Site Management
- Feasibility
- Site identification and qualification
- Investigator Site set up and initiation
- Recruitment planning and tracking
- IMP Management
- Routine Monitoring visits
- Site Management
- Motivational visits
- Site audits
- Resolutions ad responses to queries
- Site close out visits
Project Management
- Project needs assessment and contingency planning
- Overall project planning and communication planning
- Resource allocation and team management
- Risk assessment, tracking and management
- Budget development and tracking
- Management of project timelines, teams and deliverables
- Clinical study documentation
- Vendor management
Medical Writing
- Protocol and CSR
- Study Manuals
- Manuscripts and poster publications
Data Management
- eCRF design and association documents
- User Acceptance Testing
- Data Management Plan
- eCRF Completion Guidelines
- Mid study changes / protocol amendment
- Data entry / editing / verification
- Discrepancy management
- Medical coding
- SAE reconciliation
- Database lock
Regulatory Consultancy
- Regulatory and Ethics Submissions
Medical Monitoring
- Medical Monitoring 24/7 cover
- Medical assessment of subject eligibility
- Medical review of data listings
- Therapeutic area training
- Protocol and project-specific safety training at investigators meetings
Observational Studies
- Natural history of disease studies
- Rare disease registries
- Phase 4 studies
Rescue Studies
- Review of study status
- Comprehensive analysis of study issues and areas for improvement
- Experienced rescue project managers to ensure your study is back on track quickly
Statistical Analysis
- * through our trusted partners
- SAP development
- Programme listings, figures, tables
- Analysis & Statistical report
Pharmacovigilance
- * through our trusted partners
- Development and maintenance of database
- Preparation of case narratives
- Expedited SUSAR reporting
- Query resolution to case closure
- Medical Coding
- Development of DSUR
Bespoke Services
We understand that you are the experts when it comes to your product and your therapeutic area, and that one size does not fit all when it comes to outsourced clinical support. Speak to us about your requirements and we can establish whether we can help, or if we can recommend someone who can.
