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Articles and White Papers

A White Paper initiative was launched by Vantage BioTrials as part of our continued focus and dedication in providing superior clinical trial management services to the pharmaceutical industry. Please enjoy reading our free White Papers at your leisure.

As part of our commitment, Vantage BioTrials’ White Paper serves to share as an informational resource to give our readers a more detailed look at specific areas of the pharmaceutical/medical device/clinical research industry, in addition to providing our own insight and knowledge regarding certain topics, guidelines, practices and policies.

Criteria for Choosing a Great Contract Research Organization (CRO)

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 on outsourcing to Contract Research Organizations (CROs) as part of their strategy to advance to the next stage of clinical trials. As a matter of perspective, the… Read more

Prioritizing Agility When Choosing a Contract Research Organization

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

Perfectly on Time: Successfully Managing Clinical Trial Deliverables

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

Planning a Positive Outcome for Your Clinical Trial

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

CRO SELECTION: How to Find & Select the Right Partner for your Clinical Trial

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

Study Rescue | How to get your Clinical Trial Back on Track

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

How to Support & Develop Research – Naïve Clinical Sites | An Investment for the Future of 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 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

Analysis of Highlights from Health Canada’s GCP Inspection Results in 2016

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

A Synthesis of Adaptive Designs in Clinical Trials

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

Quality by Design in Clinical Research

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