Phase 1 Trial - Articles

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The Drug Development Process – From Conception to Market · Cliniexperts

The Drug Development Process –From Conception to Market Drug development encompasses the entire process of bringing a new drug to market. The drug discovery journey starts with the identification of a disease or disease area with an unmet medical need and ends with regulatory submissions and market launch. This article explores the process of drug

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Covid-19 vaccines approved for use in India – What you need to know · Cliniexperts

Covid-19 vaccines approved for use in India – What you need to know Indian, one of the leaders in the pharmaceutical sector, is set to play a vital role in the global COVID-19 vaccination effort.On 03 January 2021, the Drugs Controller General of India (DCGI) granted emergency approval for two COVID-19 vaccines –Covishield and Covaxin.

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Conducting clinical trial during COVID-19 · Cliniexperts

Conducting Clinical Trial during COVID-19 COVID-19 has caused a massive shift in how we manage clinical trials. Due to inadequate resources and restrictions placed due to the pandemic, companies are struggling to maintain the safety of study participants and staff while ensuring the continuity of ongoing trials. The pandemic also paved the way for new

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Human Vaccines – Vaccines Developmental Paradigm India · Cliniexperts

Vaccines are one of the most beneficial and valuable disease prevention measures contributing to long-term health gains. Advancements in research have led to the development of novel vaccines and delivery technologies and this is has caused a paradigm shift in the way diseases are prevented and treated. Even though the field of vaccines have evolved

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Five Regulatory Mistakes in Clinical Trials in India — And How to Avoid Them

Introduction A well-designed clinical trial can be significantly delayed — sometimes by six months or more — before a single patient is enrolled, if the Clinical Trial Application submitted to CDSCO is incomplete, inconsistent, or non-compliant. In India’s regulatory environment, where CDSCO is applying increasingly rigorous review standards under the NDCT Rules 2019, the quality

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Understanding Informed Consent in Clinical Research

Informed consent in clinical research is a cornerstone of ethical regulatory compliance. It ensures that participants voluntarily decide whether to take part in a study after receiving adequate information about its purpose, procedures, risks, benefits, and alternatives. It is an ongoing process that promotes transparency, protects participants’ rights, and supports autonomous decision-making. Introduction Informed consent


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