Publication date: February 2024 / Download PDFAuthor: Viken Bartekian Introduction Outsourcing is often a necessity within the health care industry. Many pharmaceutical, biotechnology and medical device companies rely…
Publication date: September 2023 / Download PDFAuthor: Josée Comeau Introduction Throughout the years, the field of clinical research has continued to grow in complexity and has encountered numerous…
Publication date: November 2022 / Download PDFAuthors: Vatche Bartekian, Johanna Garcia, Sheila Ernest Introduction A key skill for clinical Project Managers (PM) within the life sciences industry is…
Publication date: September 2022 / Download PDFAuthor: Vatche BartekianCo-Authors: Johanna Garcia, Kaiser Lagman, Marina Ohouo,Sheila Ernest Introduction The drug development process presents many complex steps and requires a…
Publication date: January 2021 / Download PDF Author: Marc Assaad Introduction As innovation, research and science are exponentially growing in all directions within the healthcare industry, it…
Publication date: August 2018 / Download PDF Author: Han Hsieh / Herby Delone Introduction It will probably come as no surprise for anyone to learn that most clinical trials…
Publication date: January 2018 / Download PDF Author: Robert Le Introduction Finding highly experienced and strong performing sites for a clinical trial is one of the most important steps…
Publication date: June 2017 / Download as PDF Author: Irina Mosesova Introduction At Vantage BioTrials (VBT) we pride ourselves at continuously learning and keeping up to date with the latest developments…
Publication date: May 2016 / Download PDF Author: Roy Nitulescu, Agnihotram V Ramanakumar, and Vatché Bartekian Abstract Since 2006, when the adaptive design working group presented their work…
In clinical research, “high quality” means that a study generates good, useful data, does not harm the study participants, and proceeds smoothly with few interruptions by errors or omissions. However, too many clinical research studies get mired in a time-consuming quality control (QC) process that generates numerous site monitor findings (e.g., missing data, ineligible study participants, other protocol deviations), data queries, and other after-the-fact indications that a quality problem has been found and needs to be fixed. A research site may be unable to deliver acceptable results, no matter how much the sponsor tries to help. In severe cases, the design of a study incorporates problems that make it impossible to achieve high quality results, no matter how well the study is conducted.
