Valicom specializes in auditing suppliers to ensure compliance with Good Clinical Practice (GCP). We proactively identify and mitigate potential risks that could lead to compliance issues, safeguarding both your current and future clinical studies.
Our audit expertise includes review of suppliers such as:
CRO sites and services
IRT (IVR & IWR) services
Call centers
Recruitment services
Areas of compliance review include:
Computer System Validations, including for CTMS, ETMF, EDMS, and EDC software and services, deviation and CAPA management systems, electronic training systems, and custom software implementations of these
Database services
QMS / Quality Systems, and quality manuals
PI oversight
IRB interaction and oversight
AE systems and reports
TMF and ISF content and management, including ED review
Source Data, including of source data verification (SDV) in eCRFs
CAPA and deviation procedures and systems
483 and Warning Letters, inspection history, and responses to observations
Subcontractor qualification and oversight
Facilities and their support utilities
Training and adequacy of training procedures and requirements
Laboratories and testing operations, including calibration procedures and records
DMPs and data management procedures and documents
Record retention
IP handling and pharmacy services
Study conduct
Medical monitoring
PV and participant safety procedures
Monitoring procedures and conduct, including RBM plans
Privacy of participant records, including compliance with HIPAA and EU GDPR
Staying ahead of regulatory changes:
ICH’s E6(R3) draft guidance emphasizes the importance of the QMS, of defensible risk-based approaches, of data quality and integrity, and of the controls on electronic systems that pertain to data quality and integrity. The R3 draft is expected to supersede 2016’s R2 in 2025. Valicom is committed to ensuring that your suppliers are not only compliant today but also prepared for future regulatory evolution. Contact us and we’ll help you maintain the highest standards in your clinical trials.