Regulatory Draft Gazette (Released on 24th April 2014) Addresses Medical Management of Injury Related to Clinical Trials in India

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Jun 09, 2014, 11:42 ET

RESEARCH TRIANGLE PARK, N.C., June 9, 2014 /PRNewswire/ -- Max Neeman International announced today that India’s Ministry of Health released an amended draft gazette on medical management with regards to treatment of any injury related to a clinical trial.

The new guidelines on medical management in clinical trial injury states that:

In the case of an injury occurring to the subject during the clinical trial, he or she shall be given free medical management as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.
The sponsor shall pay for the treatment of any injuries suffered by trial subjects if proven as related to the product under investigation.

The new amendments will ensure adequate care is taken in the event of an injury in clinical trial.

About Max Neeman International

Max Neeman International is a full service CRO with S.E. Asia expertise.Our specialty is that we offer services for the successful conduct of clinical trials for small and mid-sized drug/device and nutraceutical companies in compliance with ICH GCP standards. Max Neeman is ISO certified for Monitoring, Site Management and Data Management Services. Please contact: Ann Vawter - Director, Business & MarketingMax Neeman International P: 919.424.3332 / F: 919.852.5574Email: [email protected]

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SOURCE Max Neeman International