Mitigating the Challenges of Clinical Trial Monitoring: A Technology- | Page 13

Marie Hanley »

References »

VP, Global Quality Services, Clinipace Worldwide

1.  aylor N. Off-site tech-based monitoring can boost trial efficiencies. July 6,
T

Marie has worked in the clinical research industry for over 28 years. Over
the past 9 years, she has been in global regulatory and quality assurance
roles. With a B.S. in Nursing and post-graduate work in Biostatistics, she
began her research career as a research nurse and study coordinator.
Marie is a champion of compliance and process improvement.

Monika Frey »

2011. Accessed at www.outsourcing-pharma.com.
2.  arexel Biopharmaceutical R&D Statistical Sourcebook 2012/2013. Hanaman
P
D and Volkommer R, C3i, Inc. Optimizing and Supporting Remote Data
Capture, p. 233.
3.  rosteanu et al. Risk analysis and risk adapted on-site monitoring in
B
non-commercial clinical trials. Clinical Trials 2009: 585-596.
4.  DA Guidance for Industry - Oversight of Clinical Investigations – A Risk-Based
F
Approach (August 2011).
5.  uropean Medicines Agency (EMEA): Reflection paper on risk based quality
E

VP, Global Clinical Operations, Clinipace Worldwide

management in clinical trials. August 4, 2011. Accessed at http://www.ema.

Monika has 20 years of diverse clinical research experience in the

europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_

pharmaceutical and CRO industries, including monitoring, project
management, clinical operations management, quality assurance, and
general management. She has in-depth knowledge of clinical drug
development processes, GCP/ICH regulations, global business principles

listing_000136.jsp&mid=WC0b01ac05800296c4.
6.  RC/DH/MHRA Joint Project. MHRA Risk-adapted Approaches to the
M
Management of Clinical Trials of Investigational Medicinal Products. October
10, 2011. Accessed at http://www.mhra.gov.uk/Howweregulate/Medicines/
Medicinesregulatorynews/CON131943

and large-scale system applications.

John C. Parnell, III RPh, MHA »
Director, Global Clinical Monitoring, Clinipace Worldwide
John has 17 years of experience in the clinical research organization
industry. His background is in biology, pharmacy and health administration.

Mark Shapiro »
Executive Director of Clinical Development, Clinipace Worldwide
Prior to joining Clinipace, he worked as a management consulting
within Campbell Alliance’s Clinical Development and Medical Affairs
Consulting practice where he assisted many top pharmaceutical and
biotech companies with global research and development process
improvement. Mark was part of the NIH Doctoral Training Program in
Biomolecular Pharmacology at Boston University and received an MBA
from the Fuqua School of Business at Duke University.
clinipace.com

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