India improves processes for clinical trials

India improves processes for clinical trials

New initiatives from the country’s regulator aim to smooth the registration of trials and ensure prospective participants fully understand what will be involved through mandatory AV recording of the consent process. Clinical trial applications in India are taking a step forward, with the approval of a Central Drugs Standard Control Organisation (CDSCO) IT-enabled system from […]

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November 17th, 2016
New circulars released by CDSCO

Streamlined clinical trial requirements in India now in place

Effective 2nd August 2016, the Central Drugs Standard Control Organization (CDSCO) India released new circulars in relation to the conduct of clinical trials. These new circulars have modified the trial requirements for sponsors wishing to conduct clinical trials in India. Furthermore, the CDSCO have addressed matters that may assist in reducing clinical trial timelines and […]

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November 9th, 2016
Clinical trials for Rotavirus are critical in emerging countries

Clinical Trials for Rotavirus are Critical in Emerging Countries

On a global scale, rotavirus causes over 500,000 deaths in children per year, particularly in emerging countries. Rotavirus is a contagious virus that can cause inflammation of the stomach and intestines – also identified as gastroenteritis. India has predicted that almost every child would experience an episode of rotavirus gastroenteritis by the age of 5. […]

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October 22nd, 2016

Streamlined clinical trial requirements in India now in place

Effective 2nd August 2016, the Central Drugs Standard Control Organization (CDSCO) India released new circulars in relation to the conduct of clinical trials. These new circulars have modified the trial requirements for sponsors wishing to conduct clinical trials in India. Furthermore, the CDSCO have addressed matters that may assist in reducing clinical trial timelines and […]

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August 12th, 2016

New Horizons in India

The Central Drugs Standard Control Organization (CDSCO), India’s regulatory agency for clinical research, has made a series of announcements and corrections

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July 22nd, 2014

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