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[…]
Clinical trials are research investigations in which people volunteer to evaluate medical, surgical, or behavioral intervention. The trial confirms a new treatment, less side effects and helps to make a better life for people with a chronic health problem. The U.S. Food and Drug Administration(FDA) typically requires Phase I, II, and III trials to determine Read more about Plan the Clinical Trial Design – The Cloudbyz Way[…]
Healthcare industry as a whole is now looking to better engage with patients using bots, where, the patients care aspect is being automated. The impersonal nature of the bots has a benefit in various situations, wherein a real doctor is not needed. In many cases, patients are more transparent to these chatbots than they Read more about How Chatbots can be employed in Clinical Trials?[…]
Cloudbyz has added eConsent feature to its CTMS product built 100% native on Salesforce.com cloud platform leveraging innovative Salesforce lightning. Cloudbyz CTMS eConsent replaces the paper based informed consent document with interactive, multi-media enabled and template driven informed consent on mobile devices. The Cloudbyz CTMS eConsent includes template based and multimedia approaches for the presentation of information and Read more about Benefits of eConsent Solution in Clinical Trials[…]