LIFE SCIENCES ARTICLES

Clinical Trial Management System
Abhijit Joshi

Clinical Trials of the Future

The clinical research industry has been rapidly remodeled by the digital revolution.

This paradigm shift is exploding into a new way of drug development and clinical trials. A way where patient experience is at utmost precedence.

Revolving business models, services, and products around the patient is becoming the new normal.

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Clinical Trial Management System
Abhijit Joshi

How Clinical Trial Sponsors Can Help During the Spread of COVID-19

As the spread of COVID-19 has affected every industry, pharmaceutical and biotech companies are feeling the heat of it. In our last piece, we covered some of the issues the clinical trial industry, as a whole, was facing. With unexpected delays, over-flooded inboxes, and patient safety at risk, here are specific ways sponsors can and are alleviating the negative impact of the virus…

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Clinical Trial Management System
Abhijit Joshi

The Resilient CRO

Overnight, the spread of COVID-19 has disrupted seemingly every industry from airlines and restaurants, to manufacturing. As the clinical research industry races towards a cure, it too faces distinct challenges. With rapid changes in regulations, patient safety concerns, and other COVID-19 related pressures, how can

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Blogs
Abhijit Joshi

A Letter to Our Industry

Dear Clinical Research Industry,

In today’s unprecedented times, our industry is amidst all the attention.

With currently over 300 COVID-19 ongoing trials worldwide, everyone is playing their part in creating the first in-class vaccine for this virus.

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Clinical Trial Management System
Mythri Raghunandan

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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Blogs
Mythri Raghunandan

Five Key Challenges to Site Payments

Sites play a very critical role in Clinical Trials and it’s very important that they get paid in a timely manner for the services they render. However, numerous surveys have shown that sites participating in studies face huge challenges related to timely payments leading to low satisfaction scores by sites on Sponsors and CROs.

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Blogs
Dinesh Kashyap

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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Blogs
Dinesh Kashyap

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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Safety and Pharmacovigilance
Mythri Raghunandan

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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Clinical Trial Management System
Mythri Raghunandan

Verily’s Project Baseline is modernizing clinical trials

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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Clinical Trial Management System
Mythri Raghunandan

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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Blogs
Dinesh Kashyap

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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Blogs
Mythri Raghunandan

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.and interchanged often. While patient engagement refers to the

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Safety and Pharmacovigilance
Mythri Raghunandan

Five Ways to Avoid FDA Warning Letters through Automated CTMS Solution

The violations of regulatory compliance may lead to the issue of a Warning Letter FDA WARNING LETTER AND FDA FORM 483. Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices.The means no backdating records, which the agency has noted as a problem in the past.

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Clinical Trial Management System
Dinesh Kashyap

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

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Clinical Trial Management System
Mythri Raghunandan

Virtual Trials – Benefits and Challenges

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 to collect the medical data in the clinical research study. Patients are treated via Telemedicine and Medical devices. Healthcare providers can evaluate, diagnose

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Blogs
Dinesh Kashyap

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

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Blogs
Mythri Raghunandan

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

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Blogs
Mythri Raghunandan

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

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Blogs
Dinesh Kashyap

Solutions to improve Patient Enrollment and Retention in Clinical Trials

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. In…

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Blogs
Dinesh Kashyap

Patient enrollment and retention challenges 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 new and better medication…

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Blogs
Dinesh Kashyap

How Chatbots Can be Employed in Clinical Trials?

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 are…

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Blogs
Dinesh Kashyap

FDA Chooses Box for Cloud Content Management

The U.S. Food and Drug Administration (FDA) has reportedly selected Box’s cloud content management platform to modernize its technical infrastructure and drive new ways to work in the cloud. With Box, the FDA is furthering its IT innovation strategy to digitize business processes and envision new ways to engage with the

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Blogs
Mythri Raghunandan

Cloudbyz, xLM Partner to Deliver “continuously” validated Cloudbyz CTMS

This partnership combines Cloudbyz’s eClinical Trial Apps with xLM’s Continuous Validation service that enables delivery of “validated” apps. xLM, LLC, the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with Cloudbyz, a provider of eClinical apps built on Force.com.

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