Trio Clinical Resourcing
Through Trio Clinical Resourcing, an ICON plc company, we provide customized resourcing solutions to meet clinical and regulatory staffing needs for pharmaceutical and biotechnology clients. When you are looking for the flexibility to fill a single position, create a team, or outsource an entire function, we can provide experienced professionals to meet your clinical drug development needs.
Clinical Research Professionals – therapeutically aligned to support Phase I through Phase IV drug studies with:
- Study Start-up activities, including site initiation, and activation
- Clinical Monitoring to meet FDA CDER/CBER regulations and GCP/ICH guidelines
- Project Management, including planning, development, communication and tracking
- Rescue Services – analysis, corrective action planning and rapid implementation
- Medical Monitoring experts with both clinical and pharma research experience
- Medical Writing – high quality regulatory and marketing documents to meet tight deadlines
Regulatory Affairs Professionals – experienced in all therapeutic areas, emerging markets, orphan and neglected disease, and consumer products to fully support:
- Strategy development planning, agency advice and submission strategy
- Prescription drug labeling regulations and requirements
- Chemistry and Manufacturing Controls (CMC) applications and submissions
- Publishing activities to deliver compliant, timely submission component documents and valid electronic submissions
- Auditing/QC Services
Visit Trio Clinical Resourcing.