Quality by Design and Risk-Based Monitoring Publication Date: February 2015 / Download PDF Authors: Ibtissem Triki and Vanessa Towers Brief Background Over the past decade, the clinical research industry’s standard to meet regulatory monitoring obligations has involved frequent and regular onsite monitoring visits with 100% source data verification (SDV). The belief that “more is better” continues even with new evidence that on-site monitoring practices do not necessarily guarantee patient...

Quality by Design in Clinical Research Publication date: May 2015 Originally published in Journal of Clinical Research Best Practices, Vol. 11, No. 5, May 2015Author: Vatche Bartekian “Quality is never an accident. It is always the result of high intention, sincere effort, intelligent direction, and skillful execution.” – William A. Foster In clinical research, “high quality” means that a study generates good, useful data, does not harm the study participants, and proceeds smoothly wi...

Clinical Trial Management: Houston, We Have a Problem Publication Date: April 2015 / Download as PDFAuthor: Reginald Exume In the management of clinical trials, whether they be local, international, multi-site, simple or complex, a variety of situations can (or should I say will) occur that will have you saying “Houston, we have a problem!” These complications may be related to an issue at the clinical site itself, within the CRO or at the Sponsor level, but could also be caused by the study...

December 16, 2014, Montréal, Canada – With the holidays right around the corner, it will soon be time to spend quality time with family and friends.  If you have started (or will soon start) gift shopping, you will most probably start hearing Christmas carols that put us in the spirit.  The 12 days of Christmas is one of these famous carols and in line with this song, we thought we could provide you with 12 “Did you know” facts related to clinical research in Canada as our gift to you...

Publication date: October 2014 / Download as PDF Author: Viken Bartekian “A conflict of interest (COI) is a situation occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt motivation” – Wikipedia As the pharmaceutical industry continues to grow and research activities continue to expand, especially financially, new models of “doing business” are appearing at a fast pace. Outsourcing of clinical trial functions to Contra...

Publication date: September 2014 / Download PDF Authors: Vahe Bartekian and Vanessa Towers “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” – William A. Foster Organizations conducting business within the pharmaceutical industry, regardless of whether they are a sponsor or a service provider, should always hold Quality as a first priority. Unfortunatel...

Publication date: April 2014 / Download as PDF Author: Ibtissem Triki Canadian Medical Device Classifications The Food and Drugs Act (1) defines a “device” as any article, instrument, apparatus or contrivance, including any component, part of accessory thereof, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state. It includes a vast range of equipment, from a simple tongue depressor to roboti...