Protocol Amendments – Causes, Impact and Strategies

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

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Best Practices and Assumptions for Clinical Trial Budgeting

Developing a new medication is a tedious process and costs of clinical research are constantly on the rise. These are the main reasons for the decreasing trend in the number of filings with the FDA.According to the U.S. Department of Health and Human Services (HHS), clinical trial procedure costs are the highest in the first three phases of the clinical study.

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5 Things to Consider to Choose the Right CTMS

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 manage sensitive medical data

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Benefits of Risk-Based Monitoring in Clinical Trials

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.Careful and frequent monitoring can ensure…

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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, mental health, dermatology, and diabetes.

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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

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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 rather than their own internal

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