Monitoring of clinical trials is a critical activity required to be carried out during the entire lifecycle of the trial to validate that it is conducted as per the approved protocol. Monitoring should also uphold the GCP requirements to ensure the integrity of trial data, safety, and rights of subjects. The following are the major Read more about Benefits of Risk-Based Monitoring in Clinical Trials[…]
Verily, a subsidiary of Alphabet inc. and the sister company of Google Inc. has initiated Project Baseline, with the aim to leverage the collaboration of clinical research and clinical care providers to develop proactive healthcare tools and services. Verily is partnered with Pfizer, Sanofi, Novartis and Otsuka to explore the opportunities in cardiovascular disease, oncology, Read more about Verily’s Project Baseline is modernizing clinical trials[…]
A vast majority of researchers and specialized tech startup companies have started investing in developing Big Data and Artificial Intelligence (AI) tools to serve the pharmaceutical and medical devices companies, which is believed to transform the clinical trial process. But what exactly is the main outcome of AI? The buzz around AI in clinical trials Read more about Artificial Intelligence – Critical Prerequisite of Clinical Trials[…]
Bringing a new drug to the market is an expensive venture and can take up to 10 to 15 years from discovery to launch. Clinical trial costs are increasing and so is the complexity of managing it. According to the Tufts CSDD March 2019 Report, Sponsors are spending more on CROs for developing new medicines Read more about 8 Key Challenges to Clinical Trial Budgeting[…]
The modern jargons “patient centricity” and “patient-centric trials” have been revolving around the industry in recent times. However, there is a difference between patient centricity and patient engagement, which has been misinterpreted and interchanged often. While patient engagement refers to the patient’s activity and retained participation in clinical trials, patient centricity refers to the design, Read more about Making Clinical Trials Patient Centric – Essential Best Practices[…]
The violations of regulatory compliance may lead to the issue of FDA Warning Letters. Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices. Most frequent reasons to Issue FDA warning letters Document control best practices to help companies avoid FDA warning letters 1. Establish Document Control Read more about 5 Ways to Avoid FDA Warning Letters through Automated CTMS Solution[…]
Virtual trials are otherwise called Siteless trials done partly or on the whole virtually. The mobile device or wearable sensors such as a phone, watch, or even glasses can be used as the link to the clinical research study. Patients are treated via Telemedicine and Medical devices. Healthcare providers can evaluate, diagnose and treat through, Read more about Virtual Trials – Benefits and Challenges[…]
Clinical trials are essential for developing new treatments, to understand the efficiency and safety of the drugs to be used for treating Patients. People should be encouraged to participate in clinical trials as they are going to be a part of the innovation which in turn will help a huge population of suffering patients. Read more about Solutions to improve Patient Enrollment and Retention in Clinical Trials[…]
A successful clinical trial depends on effectively enrolling and retaining participants. As the study progresses from Phase 1 to Phase 3 the number of participants required increases. Research shows that 9 out of 10 trials would not meet enrollment goals in a stipulated time which results in delays in finding a new and better Read more about Patient enrollment and retention challenges in Clinical trials[…]
By Jamal Moustafaev, MBA, PMP – president and founder of Thinktank Consulting Traditional Models There are a lot of rating models out there that attempt to define project success or failure. There is the traditional one: Success: Finished (more or less) on time, within budget and met all requirements Challenged: Reaches conclusion, but with cost overruns and Read more about How to Measure Projects Success: Successful vs. Troubled vs. Failed Projects[…]