Development and implementation of a pharma-collaborative large historical control database

| July 15, 2015

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Clinical development modernization efforts have become essential as clinical trials have experienced increased expectations, costs and design complexity. The utilization of historical clinical data can enhance drug research and development by refining study design, conduct and analysis. Therefore, TransCelerate BioPharma (TransCelerate) is seeking to develop a database containing placebo and standard of care (PSoC) data from completed clinical trials with the aim to enhance innovative drug product development by better informing clinical safety interpretation and trial design. For purposes of the PSoC database, Placebo data is defined as any data generated from a control arm of a trial whereas the subject received only an inert substance. Standard of care data is defined as any data generated from a control arm of a trial whereas the subject received an active treatment.

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Malladi Drugs and Pharmaceuticals Limited

Malladi Drugs & Pharmaceuticals Ltd is one of India 's most tradition conscious and ethically sound Pharmaceutical Company. Malladi Drugs was founded in 1980 by late Mr. M L N Sastry, a pioneering microbiologist with expertise in fermentation technology. Malladi is the leading manufacturer of Active Pharmaceutical Ingredients (API) in the Cough and Cold segment along with a dominant presence in other therapeutic segments like Anti-histamines, Anti-convulsants, Anti-depressants and Anxiolytics (CNS) of the global pharmaceutical industry.

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Spotlight

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Malladi Drugs & Pharmaceuticals Ltd is one of India 's most tradition conscious and ethically sound Pharmaceutical Company. Malladi Drugs was founded in 1980 by late Mr. M L N Sastry, a pioneering microbiologist with expertise in fermentation technology. Malladi is the leading manufacturer of Active Pharmaceutical Ingredients (API) in the Cough and Cold segment along with a dominant presence in other therapeutic segments like Anti-histamines, Anti-convulsants, Anti-depressants and Anxiolytics (CNS) of the global pharmaceutical industry.

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