About Dr. Teri Stokes
Director, QA Compliance - Clinical Research Services
Cytel, Inc. Cambridge, MA
Mar 2016 - present
Develop Policy and Supporting SOPs for computer validation practices at Cytel. Train Cytel staff on how to implement validation policy and SOP practices for Software development (OQ), infrastructure platforms (IQ), and end user applications (PQ). Deployed six validation packages in first year – 2 OQ, 2 IQ, and 2 PQ. Author of Section 11 e-Clinical Trials, Electronic Records, and e-Data Regulations in Annual May 2016 edition of “Good Clinical Practice: A Question and Answer Reference Guide” published by Barnett International.
Director and Founder
1996 - 2016
GXP International helped clients prepare their organization for audits and inspections of computerized systems and electronic data handling practices to GCP, GLP, GMP, and 21 CFR Part 11/EU Annex 11 standards. From Top 10 pharmaceutical companies to startup biotech firms, CROs, and software/system suppliers, Dr. Stokes' helped clients develop and implement practical and realistic ways to meet regulatory requirements within the parameters of defined business goals. This global independent consultancy was based on the 20+ years of computer validation experience of Dr. Teri Stokes and resulted in satisfied clients and referral projects in Europe, North America, Asia, and Africa.
Various Management and Consulting Roles
Digital Equipment Corporation (DEC)
In her 16+ years at Digital, Dr. Stokes kept a focus on the pharmaceutical, biotech, and chemical industries across her various assignments. Her last assignment was as Director of Computer Validation Services in the Americas. From May 1990 to June 1995, she worked for Digital in Basel, Switzerland and established Digital’s validation services business in Europe. During 1993-95, Dr. Stokes served as a Founding Member on the Board of Directors of the European Forum for Good Clinical Practice (EFGCP) in Brussels, Belgium and participated in the Audit Working Group of the EFGCP. From 1979-1990, Dr. Stokes held various management roles with an industry focus in the Large Computer Group, Laboratory Data Products Group, and as a senior consultant on Digital’s Kodak Corporate Account Team for Global R&D Computing.
Walden University - Institute for Advanced Studies, Minneapolis, MN
PhD in Administration - Regulatory Impact of Computers Used in Clinical Trials.
Dissertation title: Clinical Data Management Trends: New Technologies and EC 1992
Lesley College, Cambridge, MA
MS in Applied Management
Thesis title: Remote Data Entry in Clinical Trials: Technology and Market Readiness
Boston University, Boston, MA
BA in Biology - PreMed Biology and Chemisty
Wellesley College, Wellesley, MA
Institute in Chemistry supported by National Science Foundation
Faulkner Hospital, Boston, MA