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About Anchor QA, LLC

We know clinical trial data governance remains challenging and is made more acute with new ICH E6(R3) guidelines.

Anchor QA’s differentiator comes from our unique expertise and agility in bridging IT and clinical gaps. With such expertise, we collaborate with Biopharma companies and develop efficient, well-controlled methods to preserve data integrity, provide traceability, protect patient privacy, and deliver accurate data verification and reporting.

Anchor QA’s Mission

We collaborate with Biopharma companies and provide strategic guidance to prepare for clinical trial data governance by improving efficiency, overseeing data integrity, and maintaining compliance, while meeting your regulatory expectations.

Anchor QA’s Vision

To lead the way in changing how Biopharma companies understand, accept, and implement data integrity, traceability, and security for their clinical trials.

About Cheryl McCarthy (RQAP-GCP, CQA, CMDA)

Cheryl is the founder of Anchor QA, LLC, a consulting firm that collaborates with Biopharma companies to improve clinical trial data governance, data integrity, and QMS in a post ICH E6(R3) world. Her capabilities and expertise cover:

  • GCP processes, service providers and technical vendors.
  • Computer system validation, data integrity and for-cause/directed compliance audits.

This combination of knowledge and experience makes Cheryl and Anchor QA excellent resources to navigate the impending global regulatory climate of ICH E6(R3) guidelines compliance, going into effect in 2025.

Cheryl has more than 30 years of expertise driving transparency and fostering compliance without hindering innovation. As an American Society of Quality (ASQ) Certified Medical Device Auditor and a Certified Quality Auditor, she has first-hand experience overseeing software quality assurance and computer system validation activities that allows life sciences companies to optimize the aggregation, standardization, and analysis of data through the clinical development life cycle.

As Director of Research Quality Assurance at Ironwood Pharmaceuticals, Cheryl was responsible for the development, implementation and oversight of GCP, GLP, and GVP quality systems. Her role centered on leading a risk-based audit program supporting clinical and post approval development activities.

Prior to Ironwood, Cheryl was Associate Director of R&D Quality & Compliance Audit (GCP) at Biogen, where she led the planning, conduct and reporting of routine and non-routine R&D GCP audits of activities, data, facilities and processes for Clinical Sites, Vendors, and Internal Processes. She implemented continuous audit process improvements based on external industry trends, internal metrics, and audit/inspection experiences, while managing audit managers and auditors to enable timely execution of audits, review and approval of audit responses.

Prior to Biogen, Cheryl was Director of Quality Assurance at eClinical Solutions, LLC. She handled activities around Quality Management System documentation development and maintenance. Along with providing consulting services for clients in the areas of QA Support, Technical and Service Vendor Audits, and SOP Development, she also conducted training programs in compliance and management, and auditing. Previous to eClinical, Cheryl held QA and QC positions where she developed internal training and oversaw and managed corporate QMS and oversaw validation of enterprise software systems. She began her career as a research associate at Rhode Island Hospital.

Since 2018, Cheryl has been a member of the Board of Directors of the Society of Quality Assurance (SQA), an association of more than 2,400 professionals dedicated to advancing GCP, GLP, and GMP within Life Sciences. Her leadership trajectory includes serving as a director in 2018, being elected as vice president in 2022, and serving as president in 2023. In 2024, Cheryl continued her contributions as the past president, including significant involvement in data integrity initiatives.

Her other certifications include SQA’s Registered Quality Assurance Professional in Good Clinical Practice and an advanced level trainer in GCP regulatory expectations and auditing. She also is part of the SQA Working Group Leadership team developing an industry reference for Data Integrity. Cheryl speaks at many industry trade conferences and has been recognized as a Distinguished Speaker by The Society of Quality Assurance Learning Foundation consistency every year since 2017.

Cheryl holds a Bachelor of Science degree in Biomedical Engineering from Marquette University.