Ciall Clinical Services
Ciall Clinical Services is an innovative consulting firm dedicated to providing GxP Quality and Clinical Operations expertise to early phase biotech and pharma sponsor companies. Their mission is to work in harmony with clients to deliver a balanced, common sense approach to clinical study conduct, emphasizing integrity, collaboration, efficiency, and entrepreneurial spirit.
Industries
Nr. of Employees
small (1-50)
Ciall Clinical Services
Products
Trial
Support for TMF responsibilities including establishing structures, reviewing plans, and conducting quality reviews for inspection readiness.
Clinical Trial Management
Day-to-day study management services provided by seasoned Clinical Study Managers from start-up to close-out.
GxP Quality Services
Quality assurance and GxP compliance support services.
Inspection Readiness Services
Specialized support for GCP inspections and GMP Pre-approval Inspections (PAIs) to collect and organize documentation and handle logistics.
Clinical Operations Services
Support services for clinical operations.
Vendor Oversight
Support for vendor oversight activities including creating oversight plans, documenting activities, and overseeing vendor work.
Trial
Support for TMF responsibilities including establishing structures, reviewing plans, and conducting quality reviews for inspection readiness.
Clinical Trial Management
Day-to-day study management services provided by seasoned Clinical Study Managers from start-up to close-out.
GxP Quality Services
Quality assurance and GxP compliance support services.
Inspection Readiness Services
Specialized support for GCP inspections and GMP Pre-approval Inspections (PAIs) to collect and organize documentation and handle logistics.
Clinical Operations Services
Support services for clinical operations.
Vendor Oversight
Support for vendor oversight activities including creating oversight plans, documenting activities, and overseeing vendor work.
Services
Interim clinical operations leadership, clinical trial management (start-up to close-out), vendor oversight, and TMF/eTMF management for early‑phase sponsors.
Full‑service quality department support including QMS implementation and management, vendor audits/qualification, GMP QA/QC support, method validation oversight, and CMC quality activities.
Preparation and support for regulatory inspections including planning, artifact collection/organization, inspection logistics, and hosting support for GCP and GMP inspections.
Validation leadership and execution for computerized systems, Part 11 compliance assessment, and implementation of validated training systems and training matrices.
Interim clinical operations leadership, clinical trial management (start-up to close-out), vendor oversight, and TMF/eTMF management for early‑phase sponsors.
Full‑service quality department support including QMS implementation and management, vendor audits/qualification, GMP QA/QC support, method validation oversight, and CMC quality activities.
Preparation and support for regulatory inspections including planning, artifact collection/organization, inspection logistics, and hosting support for GCP and GMP inspections.
Validation leadership and execution for computerized systems, Part 11 compliance assessment, and implementation of validated training systems and training matrices.
Expertise Areas
- GxP quality and compliance (GCP, GLP, GMP)
- Clinical trial management and clinical operations
- Inspection readiness and regulatory inspection support
- Quality Management System (QMS) implementation
Key Technologies
- eTMF systems
- Learning management systems (validated LMS)
- Computerized system validation
- Quality Management Systems (QMS)