Compliance Solutions

R & D

Nonclinical Program Development and Implementation

• Nonclinical program development and project management
• Nonclinical study design
• Nonclinical study report preparation, review, and interpretation
• Nonclinical study design
• Preparation and review of preclinical sections of regulatory submissions
• GLP compliance auditing and preclinical study report audits

Clinical Program Development and Implementation

• Clinical program development and project management
• Clinical study design
• Clinical study report preparation, review, and interpretation
• Preparation and review of clinical sections of regulatory submissions
• GCP compliance auditing and clinical study report audits
• Data management system design
• Biostatistics
• Safety report preparation (MedWatch, CIOMS, periodic safety update reports)
• Coordination of investigator meetings