Good Clinical Consultants
Good Clinical Consultants (GCC) specializes in providing GCP-focused quality assurance services for global clinical research trials. They focus on developing compliant vendor oversight processes, quality management systems, SOPs, and inspection readiness to ensure regulatory compliance and data integrity in clinical trials.
Industries
Nr. of Employees
small (1-50)
Good Clinical Consultants
Products
Independent GCP Audits
Independent GCP audit and consulting services including mock pre-approval inspection audits, SOP review and development, and computer systems documentation review.
GCP-Focused Quality Assurance Services
Good Clinical Consultants, Inc. provides GCP-focused quality assurance services to ensure compliant sponsor oversight of global clinical research trials.
Vendor Management
Vendor management and qualification services providing routine and qualification audits of third-party vendors, assessment of personnel qualifications, training, QA and QMS, and review of organizational structures and SOP content.
Vendor Audits
Comprehensive GCP audits of vendors and CROs conducting clinical trials to ensure adherence to federal laws and regulations.
Investigator/Study Site Audits
Independent GCP audits of clinical trial investigator and study sites to ensure compliance with Good Clinical Practice standards.
Quality Management System Consulting
Customized development and implementation of Quality Management Systems (QMS) to standardize processes, ensure regulatory compliance with global standards including ICH GCP E6(R2), and manage risks for clinical trials.
Independent GCP Audits
Independent GCP audit and consulting services including mock pre-approval inspection audits, SOP review and development, and computer systems documentation review.
GCP-Focused Quality Assurance Services
Good Clinical Consultants, Inc. provides GCP-focused quality assurance services to ensure compliant sponsor oversight of global clinical research trials.
Vendor Management
Vendor management and qualification services providing routine and qualification audits of third-party vendors, assessment of personnel qualifications, training, QA and QMS, and review of organizational structures and SOP content.
Vendor Audits
Comprehensive GCP audits of vendors and CROs conducting clinical trials to ensure adherence to federal laws and regulations.
Investigator/Study Site Audits
Independent GCP audits of clinical trial investigator and study sites to ensure compliance with Good Clinical Practice standards.
Quality Management System Consulting
Customized development and implementation of Quality Management Systems (QMS) to standardize processes, ensure regulatory compliance with global standards including ICH GCP E6(R2), and manage risks for clinical trials.
Services
Audits across study sites, CROs, sponsors, and data systems to evaluate adherence to Good Clinical Practice and regulatory requirements.
Custom QMS projects including process mapping, SOP development, document control, internal audits, CAPA systems, and vendor management processes.
Gap analysis of existing SOPs, development of required SOPs, stakeholder-aligned drafting, and implementation of SOP training programs.
Risk-based vendor oversight including qualification audits, routine assessments, QMS reviews, personnel qualification assessments, and vendor selection criteria.
Assessment of inspection readiness, conduct of mock inspections, identification of 'red flag' deficiencies, and personnel interview preparation.
Review and validation of computer systems and procedures including security, backup/recovery, and documentation to support electronic records integrity.
Audits across study sites, CROs, sponsors, and data systems to evaluate adherence to Good Clinical Practice and regulatory requirements.
Custom QMS projects including process mapping, SOP development, document control, internal audits, CAPA systems, and vendor management processes.
Gap analysis of existing SOPs, development of required SOPs, stakeholder-aligned drafting, and implementation of SOP training programs.
Risk-based vendor oversight including qualification audits, routine assessments, QMS reviews, personnel qualification assessments, and vendor selection criteria.
Assessment of inspection readiness, conduct of mock inspections, identification of 'red flag' deficiencies, and personnel interview preparation.
Review and validation of computer systems and procedures including security, backup/recovery, and documentation to support electronic records integrity.
Expertise Areas
- Clinical trial auditing and compliance
- Quality Management System (QMS) development
- SOP development and training
- Inspection readiness for FDA/EU and third-party audits
Key Technologies
- Electronic data capture (EDC) systems
- Electronic medical records (EMR)
- Computer systems validation
- Document management systems