Verily’s Project Baseline is modernizing 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[…]

Artificial Intelligence – Critical Prerequisite of 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[…]

8 Key Challenges to Clinical Trial Budgeting

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[…]

Making Clinical Trials Patient Centric – Essential Best Practices

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[…]

5 Ways to Avoid FDA Warning Letters through Automated CTMS Solution

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[…]

Plan the Clinical Trial Design – The Cloudbyz Way

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[…]

Virtual Trials – Benefits and Challenges

Virtual trials are otherwise called Siteless trials done partly or on the whole virtually. Patients are treated via Telemedicine and Medical devices. Healthcare providers can evaluate, diagnose and treat through, Telemedicine in turn leading to faster treatment and better retention. Studies show 80% of trials fail to meet targets in enrolling and retaining patients indicating Read more about Virtual Trials – Benefits and Challenges[…]

Top 5 TMF, eTMF Challenges

The trial master file is a collection of all essential clinical documents that enable the conduct of the trial and quality of data produced which is to be stored, evaluated, and maintained. An electronic TMF is the digital repository of all documents, agreements, contracts that are maintained and archived after every trial closeout. The major Read more about Top 5 TMF, eTMF Challenges[…]

Cloudbyz – Safety Pharmacovigilance Solution

  Pharmacovigilance is a continuous process of collection and analysis of data relating to the detection, assessment,  understanding, and prevention of adverse events of medicines and medical devices. Pharmacovigilance is critical for the Healthcare industry for approval of new drugs and devices and to further promote their safe use post-approval. The Challenges to Pharmacovigilance were Read more about Cloudbyz – Safety Pharmacovigilance Solution[…]

Top 5 Challenges in Pharmacovigilance

  Pharmacovigilance focuses on drug quality, medication errors and adverse drug reactions which impact the health care system by affecting a significant patient population. WHO defines pharmacovigilance as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem” Ultimately, pharmacovigilance is regarded as the constant Read more about Top 5 Challenges in Pharmacovigilance[…]