Clinical Pursuit

For many years, clinical trial stakeholders have debated over the need to incorporate electronic consent to facilitate the participants and streamline the process of data capturing. However, it wasn’t until 2020 when a vast majority of clinical research sites were forced to shut down amid global lockdown, and e-consent emerged as the hope for the continuation of clinical studies. Now, as the world has left the days of the pandemic behind, e-consent remains relevant for the adoption of a modernized clinical trial approach. Many research sites, trial sponsors, and participants now vouch for the benefits offered by electronic consent and the need for it to become a permanent part of decentralized clinical trials. However, the development and implementation of e-consent is a challenging task  across the board. And until those challenges are adequately dealt with, the clinical research industry cannot fully leverage the benefits of the model. Four Tips to Develop and Implement E-Consent...

  It was 2009 when the American Food and Drug Administration (FDA) published recommendations  for the industry to move to electronic data capture methods. Over 14 years later, the adoption of EDC has still been slow in the clinical research industry as some sponsors continue to weigh the benefits of modernized clinical trials against conventional methods. One debate that often arises in the sector is the use of paper-based clinical outcome forms and eCOA. With the former becoming less common every day, the former has yet to fully revolutionize the clinical trial sector with its plethora of benefits. If you’re a clinical researcher, sponsor, or investigator contemplating between using eCOA and paper, then here’s a comparison for you. What is eCOA? Clinical Outcome Assessment (COA) is the reflection of a patient’s experience with a drug, chronic illness, or treatment/intervention. Clinical researchers use COA for data management in clinical trials on, the basis of which the resu...

  According to estimates , the number of registered clinical trials across the world has significantly increased in recent years. Some reports suggest that there are over 443,000 ongoing trials in the US and elsewhere sponsored largely by US-based pharmaceuticals. Considering the vast number of clinical trials taking place simultaneously, it’s only natural to consider the challenges of data validation. However, in this post today, we list four ways to help clinical research organizers improve their data validation and increase data quality. What is Data Validation? Data validation is the process of rechecking the data captured during a clinical trial. This is an essential stage of clinical data management that allows organizers to make sure that the data collected during a study is accurate, does not contain human errors, and is potentially capable of delivering correct outcomes. Any errors and redundancies in clinical trial data can jeopardize clinical research as well as delay th...

  Recruitment is presumably the most time and cost-intensive part of conducting clinical research. Sponsors spend months finding the right participants for their clinical trials, only to have 30 percent of them drop out at the later stages. Or worse, the selection criterion is flawed, resulting in non-compliance with the whole study. Fortunately, technology offers a solution for clinical trial organizers to improve their eligibility and selection process. This, in turn, can reduce costs, improve clinical data capture quality, and prevent delays in marketing lifesaving drugs to the public. To learn about ways technology can streamline the clinical trial eligibility process, read this article below. What Is Clinical Trial Eligibility? Clinical trial eligibility is the process of determining the right participants for clinical research. The purpose of conducting an eligibility test is to make sure that the participants of the research are relevant, can offer valuable insights, and thu...