Why Anchor QA?
About Consulting
Data governance remains challenging and will be made more acute with new ICH E6(R3) guidelines and a new focus on risk-based quality management.
Anchor QA is different from traditional consultancies in that we can help you to proactively bridge the IT and clinical gaps and help companies to develop efficient, well-controlled means to develop methods to preserve data integrity, provide traceability, protect patient privacy and personal information, and deliver accurate reporting, interpretation, and data verification.
Anchor QA has the experience to guide, advise, and support your efforts to build a strong quality foundation as well as develop and oversee Data Governance and Data Integrity services including:
- Gap Assessments / System Reviews
- QMS Development and Oversight
- Virtual GCP QA Support (Study team support, conducting/hosting audits, and managing training compliance)
- Developing/Overseeing Computer System Validation (CSV) Programs and Infrastructure
Cheryl’s approach to Life Sciences training derives from her 30+ years of industry experience gained in her roles as a clinical research associate, a senior R&D and QA GCP leader at several clinical IT and biopharmaceutical companies, and as president for a leading life sciences quality association.
Cheryl has developed and led many GCP/GVP courses, delivering in-person and virtual training on important Quality Assurance, Data Integrity, and Data Governance topics.
An experienced trainer and speaker who has contributed to numerous industry conferences, The Society of Quality Assurance Learning Foundation has annually recognized Cheryl as a Distinguished Speaker since 2017.
We work with you to ensure readiness and preparation for any GCP or GVP regulatory inspection, as well as internal audits–from planning and preparing resources and your people to training, support, and follow-up/remediation activities.
We also can manage routine, directed, or for-cause audits in the areas of GCP/GVP, including CSV, Data Integrity, and evaluating and reporting on clinical sites and vendors/partners.