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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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Effective Site Management in Clinical Research – Points to Consider · Cliniexperts

Effective Site Management in Clinical Research – Points to Consider Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites. Site management in clinical research Efficient site management is essential to ensure that the clinical

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Biosimilars in India – Things you need to know · Cliniexperts

Biosimilars in India – Things you need to know Biological agents show significant clinical benefits, but their high cost limits their accessibility. The demand for cost-effective options and the patent expiry of biologics have propelled the development of biosimilars or similar biologics. This article covers the key takeaways from the Indian regulatory guidelines for the

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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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COVID-19 Vaccine Development: Key Developments in India · Cliniexperts

  COVID-19 Vaccine Development: Key Developments in India The Covid-19 emergency has propelled a race for preventive vaccines and treatment, with numerous efforts by companies, commercial consortia, and scientific organizations worldwide. India is a hub for vaccine production and produces 60 percent of the world’s vaccines. Indian companies have played a pivotal role in producing

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Clinical Trials For COVID-19 · Cliniexperts

  Clinical Trial For Coronavirus COVID-19 The COVID-19 pandemic continues to spread globally despite lockdowns and restrictions. The lack of definitive treatment for the deadly virus has propelled research towards a multipronged approach to mitigate transmission, morbidity, and mortality. In response to the global emergency, clinical trials assessing the efficacy and safety of interventions to

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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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