Services
CCS Associates, Inc. (CCSA) is a highly respected full-service research and development organization. Our expert professional, technical, scientific, and administrative staff brings wide-ranging experience in providing services to our government and industry clients. We take pride in our outstanding reputation for quality, innovation, and cost-effectiveness.
CCSA Services
| Strategic planning |
| Investigational studies document development and reviews |
| Regulatory document preparation (INDs, IND ARs, CMC, DMF, etc.), submission |
| Clinical trial management |
| Project requirements analysis |
| Process and procedure implementation for clinical trials |
| Document preparation, management and tracking |
| Operational process reengineering |
| Clinical trial training (GCP, Safety, Site and SOPs) |
| Document preparation, management and tracking |
| Site initiation/monitoring/close-out/QC & QA audit |
| Safety/concomitant medication data coding (MedDRA, COSTART, WHODrug) |
| Database validation |
| Data acquisition/management/analysis |
| Data management (local, remote, web-based) |
| System development/web-based, secure (regulatory, clinical, safety) |
| Quality assurance (FDA, ICH, GLP, GCP, NCI, OHRP, HIPAA) |
| 21 CFR Part 11 knowledge and compliance |
| Literature research and retrieval |
| Data archiving |