articles by Mythri Raghunandan

CTMS
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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Cloudbyz Careers & Culture
Mythri Raghunandan

Spreading Smiles One Step at a Time !!!

Team Cloudbyz got together for the most fulfilling time spent on Nov 6th at Samarthanam Trust – an organization for the differently-abled located at HSR Layout, Bangalore. The officer on duty at the Trust was very warm and explained about the early days of the institution and the Himalayan strides they have made with the help and support of many philanthropic minds.

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Clinical Trial Budget Management
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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video
Mythri Raghunandan

ClinicalWave Patient Recruitment

ClinicalWave Patient Recruitment Solutions helps in connecting Patients, Researchers, CROs and Sponsors on a Single Digital Platform, thereby improving patient engagement and retention.

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video
Mythri Raghunandan

Cloudbyz CTMS

What Makes the Solution Unique Choice for Clinical Trials? Watch the Video to Know more…

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Clinical Trial Budget Management
Mythri Raghunandan

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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Cloudbyz Careers & Culture
Mythri Raghunandan

Dynamic Culture Drives Innovation

Culture is the way people treat each other, day-in and day-out, working as a team towards a common goal. These are not a list of hard rules to be followed but are the values to be implemented. The best company’s culture is where employees are released from stress and perform well at work.It’s difficult or…

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CTMS
Mythri Raghunandan

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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Cloudbyz Careers & Culture
Mythri Raghunandan

Cloudbyz’s Positive Step Towards Green Earth

World environment day was celebrated by Cloudbyz at the SeedBall Creation drive organized by Saytrees on Sunday, 9th June 2019.Our employees aka Nature lovers took time out of their weekend and gathered to support a cause, “SeedBall creation Drive” an easy and sustainable way of increasing the green cover.One lakh seed balls were

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Patient Recruitment
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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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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Virtual Trials
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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eTMF
Mythri Raghunandan

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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Patient Recruitment
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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Pharmacovigilance
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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Patient Recruitment
Mythri Raghunandan

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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CTMS
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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