WINNIPEG, MB – January 20, 2010 - GVI Clinical Development Solutions (GVI-CDS), an innovative CRO focused on quality, timeliness and cost effective services, is pleased to announce that Douglas A. Elliott and Sandra Reis have joined GVI-CDS. The addition of these two experienced clinical and regulatory specialists expands the organization’s capabilities in clinical and regulatory strategy and enhances its service offering to clients.
”Adding skilled and experienced team members like Douglas and Sandra is an important achievement for our growing CRO. These additions complement the clinical trial management, data management and strategic consulting services already offered by GVI-CDS”, stated Jan-Ake Westin, President of GVI-CDS.
Douglas A. Elliott joins GVI-CDS as Director of Clinical Affairs. Prior to joining the organization, Mr. Elliott played a similar role with well known CROs Covance Canada, i3 Research, and Innovus Research. Over Mr. Elliott’s 20 years in the industry, he has been responsible for starting up and developing clinical units within two separate pharma companies, developing and managing strategic partnerships between industry and academic research units and for setting up and managing large clinical studies, including the first ever multi-centre Canadian study on Alzheimer’s Disease.
Sandra Reis recently joined GVI-CDS as Director of Regulatory Affairs. Prior to joining the organization, Ms. Reis played a similar role at Intrinsik Health Sciences Inc. where she was responsible for activities such as overseeing the preparation and filing of regulatory submissions (e.g., INDs, CTAs, NDA/NDS/MAAs, IDEs, ITAs, PMAs, 510(k)s), interacting with regulatory agencies on behalf of domestic and international clients, developing regulatory strategies for product speed-to-market, advising on regulatory risk associated with promotional activities, and providing guidance on the regulatory aspects of product life-cycle management.
“Owing to our strong and growing team, we believe that we have the most entrepreneurial and service minded contract research organization in North America, making us the ideal partner for growth minded life sciences companies, clinical investigators and public research institutions. We welcome Douglas and Sandra to our team and look forward to the enhanced service offerings that they bring to our current and future clients,” concluded Westin.
About Douglas A. Elliott
Douglas A. Elliott is an innovative and accomplished senior level clinical specialist with a wide variety of experience both with international pharmaceutical companies and with global CROs. Mr. Elliott has extensive contacts with key opinion leaders and has clinical research experience in a number of therapeutic areas including cardiovascular, metabolic, oncology, gastroenterology, respirology, neurology, psychiatry and ICU/critical care. Mr. Elliott has a Masters of Science in Pharmacology from the University of Manitoba.
About Sandra Reis
Sandra Reis is a skilled Regulatory Affairs Professional who is proficient in the development and execution of regulatory strategies and the preparation of high quality regulatory submissions, resulting in the reduction of product time-to-market. Specific capabilities include preparation, compilation, and submission of regulatory filings (i.e. INDs, CTAs, NDAs/NDSs, DMFs, ANDAs/ANDSs, 510(k), NHP Product Licensing); interacting and negotiating with Regulatory Authorities on behalf of clients; providing guidance on the regulatory aspects of product life-cycle management (from early development through to commercialization and beyond); and advising on regulatory risks associated with promotional activities. Sandra graduated with a degree in Biology, obtained a post-graduate diploma in Regulatory Affairs & Quality Operations and has completed numerous additional seminars and certifications on topics including Preparing Global Regulatory Strategies, Conduct of Clinical Trials, Electronic Submissions, Streamlining the Regulatory Process, and Promotion, Compliance & Enforcement.
About GVI Clinical Development Solutions
GVI Clinical Development Solutions (GVI-CDS) is an innovative CRO focused on quality, timeliness and cost effective services. It is committed to excellence in clinical development services with particular experience in the cardiovascular and metabolic disease areas. GVI-CDS’ flexibility and active participation in the critical stages of the clinical development process makes it an ideal partner for small and midsized life science companies, and academic or public health institutions carrying out their own clinical trials. Further information on GVI-CDS’ clinical project management, clinical trial monitoring, clinical trial and drug safety evaluation, clinical site document management, regulatory affairs and clinical quality assurance and data management services can be found at www.gvicds.com. We consistently deliver!
For more information please contact:
Michael Coutts
Director, Business Development
GVI Clinical Development Solutions
Phone: 204-477-7597
Fax: 204-453-1370
mcoutts@gvicds.com