“Peri Clinical Studies” and “Adaptive Clinical Trials”

While in the drug development, the clinical translatable supporting evidences are constantly required, but stumbled upon

 the rigid implementation, long turnover time, and costly financial sustenance of clinical trials. Prisys accesses over ten

 thousands of monkeys in the breeding inventory, such a unique population that can facilitate the preparative, adaptive, or

 applicable studies justifiable for a more scientific and flawless development or advancement of the clinical trials.

 

 •  The population of outbred monkeys, different from the genetic pure animals, is better representing human patients

     recruited for evaluating the effects of a drug compound

 •  Selecting the monkeys similar to the clinical trials based on the demography, such as gender, age, BMI, biochemistry,

    menstruation, infertility, …

 •  Study design in the same way as a clinical trial: groups, primary endpoints, secondary endpoints, blindness,

     randomization, and statistics…

 •  Direct comparison of SOC or reference drugs at the clinical relevant doses and effects

 •  Testing dose-effects, dose regimen, and routes of administration in relevance to clinical trials

 •  Complete clinical parameters, such as CBC, coagulation, chemistry, hormone, lipids, CRP… as the references;plus,  

     the additional intermediate parameters, such as cytokines, cellular functions, organ functions, biopsies, etc. from

     normal, pre-disease, disease, and following treatment in the monkeys, providing more faithfully projecting design of

     clinical trials

 •  Clinical relevant critical diseases that are difficult in efficient implementation in clinical trials, such as bleeding, 

     postpartum hemorrhage, trauma, renal failure, end stage of liver disease, heart attack, cachexia, etc.

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