Regulatory Documentation
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.
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.
Examples of CCSA’s portfolio of regulatory-derived products under government and private client contracts and collaborations include:- Regulatory strategic planning, FDA (CDRH, CBER, CDER). Communication/correspondence, and meeting organization and execution.
- Preparation and maintenance of over 85 INDs/NDAs and IDEs. Examples: Preparation and submission of numerous drug INDs, including a Master IND for an adaptive-based clinical trial design with multiple investigational pharmaceutical drugs and biologics. Successful preparation and submission of an orphan drug-designated IND for a private client. Support in preparation and submission of multiple imaging devices/in vitro diagnostic IDEs. Preparation of INDs/NDAs for PET imaging agents as well as structured product label (SPL) for government-sponsored studies. Preparation of non-clinical and clinical sections of NDAs/sNDAs for private clients. Preparation of multiple non-clinical toxicology sections in eCTD format sponsored by private clients.
- Preparation of Investigator’s Brochures and Clinical Development Plans in support of government and private-client R&D programs.
- Draft and maintenance of imaging charters for government-sponsored studies.
- Design and development of protocols and informed consents in support of investigational studies conducted under INDs and IDEs. Examples include natural products, small molecules, biologics, various imaging modalities (e.g., FDG/PET, MRI, ultrasound), probes (e.g., FES, FMISO, FLT), and agents (e.g., NaF).
- Preparation of study and progress reports in fulfilling regulatory (US and ex-US), DSMBs, IRBs, and Steering and Executive committees for the sponsored studies.
Preparation of overviews on the state of the art in biomarker development including regulatory strategy (e.g., novel imaging probes, predictive biomarkers). - Organization and participation in training sessions and workshops for project teams and study staff for the government and private client-sponsored investigational studies in support of the R&D programs.