Services
Regulatory
- Pre-clinical and clinical program evaluation
- Regulatory strategy development
- Regulatory submissions (IND, NDA, BLA, ANDA, 505(b)(2),
510K, IDE, PMA)
- Lab (GLP) and site (GCP) audits
- FDA meetings and presentations
Clinical Trial Conduct
- Trial planning and project management
- Protocol development
- Investigator identification and recruitment
- Global sites database
- Site qualifications
- Investigator meetings
- IRB assistance
- Third party vendor management
- Clinical monitoring
- Site initiation
- Interim monitoring
- Site training
- Site closeouts
- Site regulatory document control
- Trial Master File maintenance
- Safety monitoring
- SAE database
- Physician 'hot line'
- SAE narratives, Medwatch & CIOMS reports
- FDA & sites notifications of SAEs
- Annual safety reporting
Biometrics
- ICH E9 compliance
- CRF design (EDC or paper)
- Database design and creation
- Data entry and cleaning
- Statistical Analysis Plan
- Analysis tables, listings, and graphs
- Online data review
- Interim Analyses
- Integrated Summaries of Efficacy or Safety
- Exploratory and meta analyses
- Multi-study data integration
- Data Safety Management Board
Medical Writing
- ICH-compliant Clinical Study Reports
- Statistical Analysis Reports
- Investigator Brochures
- Protocols
- GLP/GCP Audit Reports
- Summaries, Manuscripts and Abstracts
- Scientific papers
- White papers