Our Drug Development Services

CCSA provides a number of integrated drug development services to further our clients' goals. Our staff of scientists, medical and regulatory professionals, and clinical research associates (CRAs) has academic, governmental, and industry experience.

We are a full-service CRO. We design, monitor, and manage all phases of clinical studies and provide regulatory, clinical data management, biostatistical, technology assessment, and medical/scientific writing services tailored to specific drug development programs. CCSA strategically plans, prepares, and submits regulatory filings to US and foreign regulatory bodies. We have more than 15 years experience and a solid track record in managing single- and multi-site investigational sites. At CCSA, project management teams are structured to fulfill each client's drug development needs.

We Provide:

Clinical Trial Management

• Site Identification
• Qualification and Investigator Recruitment
• Site Monitoring (Pre-study, Initiation, Routine, Close-out)
• Quality Assurance/GCP/ICH/NIH/OHRP Compliance and Audits
• Data Management
• CRF Design
• Biostatistics/Data Analysis
  

Regulatory Affairs

• Strategic Planning
• IND, NDA Preparation and Management
• Protocol/Informed Consent Design
• IRB Liaison
• Regulatory Document and SOP Maintenance
• Pharmacovigilance
• Nonclinical Drug Development
• Literature Search and Background Preparation