Phase 4 Trial (PMS) - 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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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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Online submission of SAE reports through SUGAM portal · Cliniexperts

Online submission of SAE reports through SUGAM portal The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame. CDSCO, through the SUGAM portal, started the process of electronic submissions of

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GSR Notification #227: Paving the Way to Clinical Research in India (Part II) · Cliniexperts

The application for permission to conduct clinical research India of a new drug or investigational new drug has to be made in Form CT-04 in place of Form 44. The following are the new provisions to be followed during clinical trials’ conduction in India. Clinical Trials Enrolment Status The clinical trial enrolment status of the


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