Yes, Castor CDMS fully complies with the clinical, technical, and data privacy regulations required to conduct CTIMPs (Clinical Trials of Investigational Medicinal Products).
Castor is widely used by pharmaceutical sponsors, biotech companies, academic medical centers, and CROs to run Phase I–IV interventional drug and medical device trials globally.
How Castor CDMS Supports CTIMP Compliance
1. Regulatory & Quality Standards
- ICH-GCP (E6 R2): Castor provides the controls necessary for sponsors and investigators to fulfill their responsibilities under Good Clinical Practice guidelines.
- EU Clinical Trials Regulation (CTR 536/2014) & UK Regulations: Designed to meet European and UK regulatory requirements for interventional drug trials.
- FDA 21 CFR Part 11 & EU Annex 11: Features full computerized system compliance, including secure user authentication, role-based permissions, and electronic signatures.
- Software Validation (GAMP 5): Castor is developed and maintained under an ISO 9001 and ISO 27001 certified Quality Management System following GAMP 5 principles, with formal Release Certificates provided for every software version.
2. Data Integrity & Clinical Operations Tools (ALCOA+)
- Comprehensive Audit Trail: All data entries, modifications, and deletions are automatically logged with a date/time stamp, user ID, and previous values.
- Mandatory Reason for Change: In compliance with GCP, the system can require users to supply a reason whenever previously saved data is updated.
- Monitoring & Source Data Verification (SDV): Dedicated workflows for Clinical Research Associates (CRAs) to perform SDV, create and manage queries, and freeze or lock records.
- Adverse Event & Safety Reporting: Repeating data structures allow seamless logging of Adverse Events (AEs), Serious Adverse Events (SAEs), and concomitant medications.
3. Data Privacy & Local Hosting
- GDPR & HIPAA Compliant: Full compliance with the EU General Data Protection Regulation (GDPR), UK Data Protection Act, and HIPAA.
- Regional Cloud Infrastructure: Hosted on certified Microsoft Azure medical cloud infrastructure with dedicated regional instances in the European Union, United Kingdom, United States, and Australia, ensuring compliance with local data sovereignty requirements.
Relevant Documentation for Your Trial Master File (TMF)
- ISO Standards and Certificates
- Annual 21 CFR Part 11 Statements of Compliance
- Enabling GCP Reason for Change in CDMS
- For vendor qualification audits, validation summaries, or Data Processing Agreements (DPAs), contact Castor Compliance.