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 time management. As a PM, you are not only responsible for the project deliverables, but for every person involved as well as every task performed. Yes, it… Read more

A key skill for clinical Project Managers (PM) within the life sciences industry is time management. As a PM, you are not only responsible for the project deliverables, but for every person involved as well as every task performed. Yes, it… Read more

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 keen set of skills, knowledge, and resources to arrive successfully at subsequent stages . Within the various phases of drug development, clinical trials, in particular, require robust,… Read more

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 is only normal that the outsourcing of Clinical Research Organizations (CROs) is also rapidly growing, resulting in a spike in the numbers of such organizations available to… Read more

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 do not proceed as planned since more than 90% of them fail to meet their original timeline.1 The reason a study falls behind schedule or even fails… Read more

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 in the drug development process, but always remains a challenging task for Sponsors and CROs. The turnover rate of Principle Investigators (PIs) in clinical research is high… Read more

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 in clinical research and compliance issues that can potentially effect trial results or even patient safety. The industry is changing at an incredible rate and in an… Read more

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 Washington D.C., the literature on adaptive designs has greatly expanded. Some designs have emerged as inherently better suited to exploratory-phase trials, while others are more appropriate… Read more

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. Read more

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 protocol or the investigational drug itself. This white paper will present a methodology to optimize clinical trial management by using best practices, as well as how to avoid and resolve problematic situations that may arise throughout the trial. Read more

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 safety and data quality. An electronic survey was conducted by the Clinical Trials Transformation Initiative (CTTI) in 2008 to assess the clinical monitoring practices utilized across different types of organizations involved in clinical research. The results published in 2011 have highlighted the heterogeneity in monitoring practices between clinical trial organizations, and the key conclusion is that traditional monitoring is inefficient and doesn’t always lead to increased patient safety and data quality in clinical trials. Read more

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 challenges, and although processes have been well established, many of us have settled into a daily routine that maintains the status quo. It’s time for us to… Read more