TMG is very pleased to announce the issuance of our most recent update to the TMG Biomedical Research Site Standard Operating Procedures, on January 9, 2012, with an implementation date of February 6.
Our goal in updating the SOPs has been three-fold:
1.To provide TMG sites with tools that will help them to perform more efficiently and with high quality (e.g., provision of additional/ revised forms)
2. To provide TMG sites with supplemental information that will help them to meet ever-evolving sponsor and regulatory expectations, thereby attracting more studies to TMG sites
3. To reflect developments in technology (e.g., transition from paper to electronic CRFs, use of IVRS systems)
TMG SOP revisions are drafted based on feedback from our TMG sites, inspection findings and clinical research literature. The 2012 version of TMG SOPs will provide TMG sites with information and tools that will assist in the achievement of excellence in their day-to-day work.
Detailed information on the changes that have been made and on the steps required to implement the new SOPs will be included in the SOP package that will be mailed to TMG sites during the week of January 9.
Elizabeth Rafeiro has recently joined TMG as a Project Manager. She has over 14 years of experience in clinical research, beginning her career as Director of Clinical Research in the Division of Allergy & Immunology at Kingston General Hospital. She subsequently spent 5 years working for Boehringer Ingelheim Canada Ltd., most recently as a Therapeutic Area Specialist where she was responsible for local oversight of clinical trials in Metabolism and CNS and for the management of international clinical trials. Elizabeth obtained her PhD in Pharmacology & Toxicology from Queens University.
Trial Management Group is proud to announce that we are the sponsor for our second influenza treatment study. The ACCESS study is a Comparison of Time from Symptom Onset to Oseltamivir Access when Oseltamivir is prescribed by Pharmacists as compared to Physicians and the Impact on Symptoms, Oseltamivir Resistance and Patient Safety. With recruitment expected to begin in November, the study is being conducted at 12 Research Sites across Canada where each Site is comprised of a study clinic and pharmacy located in close proximity to one another.
Rachael comes to TMG with previous experience in Global Operations at GlaxoSmithKline. Her role at TMG will be as our Clinical Research Recruitment Associate, responsible for ensuring that the TMG investigators are taking advantage of every opportunity to maximize their subject recruitment. Rachael graduated from the University of Western Ontario with an Honors BSc specializing in Genetics. She also earned a Masters of Biotechnology from the University of Toronto.
Marc will be taking on the role as Contract Analyst at TMG. Marc will be responsible for reviewing and negotiating the terms of the clinical trial agreements between TMG investigators and the Sponsors or CROs managing the studies. He will also be responsible for managing contracts for sites and suppliers in TMG sponsored studies. For the past 12 years, Marc made his living as a professional hockey player. He graduated from Miami University in Ohio with a B.Sc. in Education and is currently enrolled in the Masters in International Management program at the University of Liverpool, by correspondence