CCSA has wide-ranging experience managing and maintaining all regulatory documentation on behalf of sponsors during the complete study lifecycle. We work closely with study staff at clinical sites to collect all study start-up regulatory documentation in accordance with ICH-GCP guidelines and sponsor specifications while adhering to strict timelines and budgets. We also collect, track, manage, and maintain ongoing documentation throughout the duration of the clinical trial.
At study completion, CCSA collects study close-out documents in accordance with ICH-GCP guidelines and sponsor requirements. All regulatory documentation undergoes rigorous review by our Quality Assurance department and is managed and maintained via electronic databases and web-based management systems.
Data from properly designed and rigorously monitored clinical trials is the gateway to regulatory approval for pharmaceutical and other medical products. CCSA provides the necessary oversight in a cost-effective manner, and produces quality results in the form of impeccable data.
CCSA’s expert regulatory affairs professionals, experienced project managers, Clinical Research Associates and our Data Coordinating Center are prepared to assist in every step from study initiation to published results.
Study Start-up-
CCSA experts actively participate to ensure rapid start up for all phases of your clinical studies.
- Site identification, qualification, and selection
- Investigator recruitment
- Investigator agreement/payment
- Study supply management
- Central laboratory management
- We provide study specific and customized document management and coordination:
- Study/regulatory/coordinator manual preparation and maintenance
- Source document management
- eCRF design and development
- eCRF completion guidelines
- Investigational drug logs and tracking
- Deviation management
- IRB/ethics documentation, preparation, submission, and tracking
- Safety reporting coordination
- Query resolution coordination
- Monitoring plans development and maintenance
- Our project teams assure application of standard study-specific procedures by providing:
- Investigator and initiation meetings including planning and organization
- Site training
- Investigator/patient retention strategies
- Facilitating and maintenance of site communications
- On- and off-site monitoring and coordination activities ensure data timely data collection and quality. We provide:
- On- and off-site survey contacts and qualifications
- On-site monitoring (pre-study, initiation, routine, closeout)
- GCP/ICH/NIH/OHRP/HIPAA compliance
- Query and discrepancy resolution
- Site education
Quality Assurance
After more than 20 years in business, our grasp of regulations, practices, and tools for assuring the quality of data is unmatched. Experienced nonclinical and clinical quality assurance and compliance professionals ensure compliance with FDA as well as ICH/GCP/GLP guidelines. Our rigorous audit program goes in-depth to check systems, investigational sites, and documents for GLP/ICH/GCP compliance.
Client-specific audit plans are created to address each audit goal. Clients receive written reports at the conclusion of each audit with detailed observations and required corrective action.
CCSA plays a major role in preparing clients for regulatory inspections.- Our quality assurance experts provide:
- Preparation and maintenance of audit plans
- Nonclinical, clinical and regulatory audits:
GLP/FDA/ICH/GCP/OHRP/HIPAA compliance - Corrective action plans and follow-ups
- Site staff training and education
- Site and study audits
- Site qualification
- Data system audit
- Study data audit
- SOP and compliance audit
- CRO audit