Introduction Protocol plays a central role in the efficient execution and completion of a clinical trial. Any change to the agreed protocol that affects the safety of subjects, scope and quality of study is considered unavoidable. These changes result in delays in Study timelines, lower patient retention rates, Site burdens, impending costs etc.. According Read more about Protocol Amendments – Causes, Impact and Strategies[…]
ClinicalWave Patient Recruitment Solutions helps in connecting Patients, Researchers, CROs and Sponsors on a Single Digital Platform, thereby improving patient engagement and retention.
What Makes the Solution Unique Choice for Clinical Trials? Watch the Video to Know more…
A number of solutions are being built to manage day-to-day clinical trial activities. Most solution providers in the market claim to have a complete CTMS solution, however, not all solutions have end-to-end features. A checklist for systematic assessment of the available CTMS solutions prior to investment is essential. Most importantly, CTMS will be used to Read more about 5 Things to Consider to Choose the Right CTMS[…]
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 jargon “patient centricity” and “patient engagement” has been revolving a lot around the industry. Patient centricity refers to the design, development, and conduct of clinical trials, keeping in mind the needs of the patient. Patient engagement refers to the patient’s activity and retained participation in clinical trials. There is a huge difference between 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[…]