Medidata Solutions, a global provider of electronic clinical data
capture, management and reporting solutions, today announced the
expansion of its senior management team with the appointments of Dr.
Barton Cobert as Vice President of Global Regulatory Initiatives and
Pharmacovigilance, Frances Nolan as Vice President of Global Quality
Assurance and Dr. Tony Hewer as Senior Director of Global Quality
Assurance for EMEA. These three executives bring a range of clinical
development expertise to the Medidata group headed by Earl Hulihan,
Vice President of Global Regulatory Affairs and Quality Assurance.
"The pharmaceutical, biotech and medical device industries have
always adhered to the highest standards of safety and quality
assurance, and we have made very strategic choices in our selection of
the executives who will drive these key areas," said Tarek Sherif,
Co-founder and CEO at Medidata Solutions. "Each of these three
executives brings critical pieces of expertise and experience in the
clinical arena that will support Medidata's growth into new global
markets while ensuring customers' adherence to industry standards and
regulations."
Dr. Barton Cobert, Vice President, Global Regulatory Initiatives &
Pharmacovigilance
As Vice President of Global Regulatory Initiatives and
Pharmacovigilance, Cobert is responsible for interactions with
regulatory agencies, oversight of Medidata's quality processes,
knowledge and understanding of local and international regulations and
company visibility in the international arena. Cobert has more than 20
years of pharmaceutical industry experience, specializing in product
safety and pharmacovigilance. He most recently served as global head
of drug safety and pharmacovigilance at Novartis' Consumer Health
Division, where he was responsible for worldwide drug, device,
cosmetic, nutritional supplement and adverse event reporting. He also
has held various management positions in pharmacovigilance, medical
research, medical safety and services at Hoechst-Roussel,
Schering-Plough, Forest Research Institute and Becton Dickinson.
Cobert received his M.D. from New York University in 1974 and served
as a physician in a range of hospitals in both the U.S. and Europe. A
frequent contributor to industry and medical journals, Cobert has also
written two textbooks on drug safety.
Frances Nolan, Vice President, Global Quality Assurance
Nolan joined Medidata in December 2006 as Senior Director of
Quality Assurance and was appointed Vice President of Global Quality
Assurance in April 2007. In this new role, Nolan is responsible for
ensuring Medidata products and services achieve and maintain
compliance with industry standards and best practices. With more than
30 years experience in the pharmaceutical and software industries,
Nolan has extensive expertise in regulatory compliance, including
electronic records/electronic signatures (including US FDA 21 CFR Part
11), computer system validation and privacy and risk management. Nolan
has held a number of positions in IT and quality assurance at leading
companies including Taratec Development Corporation (now Patni), a
regulatory compliance consulting company, where she drove compliance
strategies and solutions. She also served as the worldwide head of
Pfizer R&D's 21 CFR Part 11 Program and director of systems and
services management for Pfizer's corporate clinical and regulatory
systems group, and Oracle's U.S. director of customer satisfaction and
quality. Nolan has been an active participant in the Industry
Coalition on 21 CFR Part 11, a frequent presenter in global forums
such as the DIA Annual Meeting and DIA Workshops and a contributor to
the 2006 Red Apple 2 Conference on Computerized Systems for
Non-Clinical Safety Assessment.
Dr. Tony Hewer, Senior Director, Global Quality Assurance for EMEA
As the Senior Director of Global Quality Assurance for EMEA, Hewer
is responsible for refining and maintaining robust, up-to-date quality
and regulatory standards for Medidata products and services. Hewer has
more than 25 years experience in the pharmaceutical, IT, and
management consultancy industries and most recently led a team of
pharmaceutical IT QA professionals in Asia Pacific. He has held a
number of senior IT management and leadership positions with Pfizer
and also previously worked for Braxxon Technology Limited and Data
Logic Limited in the wholesale banking industry in London,
specializing in front-office systems as well as IT operational
effectiveness.
About Medidata Solutions Worldwide
Medidata Solutions helps the world's leading pharmaceutical,
biotechnology, medical device and research organizations maximize the
value of their clinical research investments. Innovative process
design, technology and services streamline clinical trials by
providing early visibility to reliable clinical data - the lifeblood
of every research organization. Working with companies and
institutions both large and small, Medidata Solutions helps clinical
researchers safely accelerate the process of bringing life-enhancing
treatments to market - on six continents and in more than 80
countries. Medidata Solutions brings significant value to its broad
client base with deep clinical experience and expertise in more than
20 therapeutic areas, projects in Phase I, II, III, IV, registries and
surveillance, and studies with thousands of investigators and
tens-of-thousands of subjects. For more information, please visit
www.mdsol.com.
