Regulatory Inspection Readiness
Risk Based Oversight, ICH E6, R2
Quality Management Systems
Quality by Design, ICH E8
CQA Audits
Vendor Qualification
Investigator Site
CROs
Trial Master File Gap Assessment
Electronic TMFs
Paper TMFs
TMF Migrations (Veeva, PhlexGlobal, Aris Global, Montrium Connect, Trial Interactive)
Our Services
Clinical QA
Risk-based Quality Approach
- Clinical QA Leadership- Quality program development, planning and oversight
- Subject Matter Expert for GCPs and ICH guidelines
- Phase 1-4 Clinical Trials
- Auditing- (US/Global)
- Standard Operation Procedures (SOP) gap analysis/harmonization
- CAPA reviews
- Risk-based monitoring trend analysis
- Incorporating Quality by Design
- Quality Management Systems
Clinical
Operations
Expert
consulting
Subject Matter Expert for Clinical Neurological and Health Psychological research: Dementia/Alzheimer’s, ALS, CNS, Pain Management, ADHD, Mood disorders
Experienced in Oncology, Hemotology, Dermatology, Cardiovascular, Diabetes, and other indications.
- Sponsor Oversight activities
- Develop Clinical Monitoring Plans, Project Management Plans
- Risk assessment data analysis
- CAPA procedures
- Inspection Readiness task tracking
- QC of Clinical Study Reports, Data Tables and Listings
- Protocol drafting/review
- Investigator Brochure drafting/review
Our team
Clinical Compliance Consultants provide expertise in GXP with each consultant averaging 25 years of experience in the industry. Having worked with clients in Big Pharma to Biotech startups, we understand the varying needs of sponsors at each stage of product development and company growth while ensuring compliance through the transitions.
Contact us
Telephone: +1 (502) 797-0202
E-mail: NatalieM@CCCGXP.com
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