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PA
The Team
Short Biography
Danielle Jacobs
Director Clinical Research Services
Dr. Danielle Jacobs has 35+ years’ experience in the field of clinical research (GCP), in Operational (10+ years), and Quality Assurance (QA) (20+ years) roles. She has applied her skills in pharmaceutical, Biotechnology, and medical device companies, in Contract Research Organisations, and in academic settings. Her work has been conducted in a variety of countries around the world. Danielle’s QA expertise includes: a) setting up and management of Quality Management Systems (QMSs), b) auditing, and c) Corrective Action/Preventive Action (CAPA) management. She also has significant experience in: a) GDPR services, b) writing of GCP-related documents; c) clinical research- and GCP-related training; d) project and departmental management; and e) clinical research operations.
Colin Goddard
Director Computer Compliance Services
Colin has 35+ years of experience in the field of computer compliance within the health care industries, primarily concerned with GCP related activities within the European Union. In addition to providing internal and external audit services, computer compliance assessments and related training, Colin’s experience has included working as a European IT Director for an international Bio-Tech company, Associate QA Director for a major internal pharma company and Project Manager for a major (cardio) IMT image based clinical trial; responsible for finalising the study and verifying the integrity of the final study database generated from the start of the trial. Prior to moving into the healthcare services, Colin gained his experience within IT by working as an IT Manager, Project Manager, Software Development Manager and Programmer within various European international companies.