Our Services include...

Early-Stage Clinical Development

• Protocol Development and CRF Design
• IND Preparation and Submission
• Preparation of Comprehensive Product Development Plans
• Evaluation of Data Management Plans
• Preparation of Statistical Analysis Plans
• Assessment of potential new chemical entities and clinical development candidates
• Study Monitoring, Project and Program Management
• Clinical Drug / Device Supply Management
• Study Site Evaluation and GCP/ICH Compliance Audits

Routine Clinical Operations

• Study Site and Regulatory (GCP/ICH) Training
• IND Safety Report Tracking and Management
• Medical Safety Surveillance / Pharmacovigilance
• IND program Annual Reports
• Study File Management and Scanning (preparation for eSubmissions)

Clinical Research Activities

• Medical Writing / Medical Communications
• Data Management
• Statistics and Programming
• Preparation for FDA Meetings

Late-Stage Development Services

• NDA / BLA / CTD Development
• Advisory Committee Preparation and Training
• Presentation and Poster Development
• Manuscripts and Publication Plans