Early-Phase clinical research aims mainly to determine the effects of the drug for the first time in humans: how it is absorbed, metabolized and excreted. During this phase, researchers also investigate potential side effects that occur based on the dosage levels. Early phase studies on experimental drugs can show the potential and future benefits of new compounds. MPR understands the complexity of conducting early phase clinical trials and has, therefore, expanded capabilities to serve the research community in several locations. We currently support patient-based early phase clinical trials and plan to expand our capabilities to manage healthy volunteer-based studies.

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Clinical Units

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We support early phase clinical studies via several units, geographically-dispersed to offer our clients accessibility to a large pool of volunteers with particular demographics and characteristics. We follow centralized procedures and SOPs (Standard Operating Procedures).

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Research Units – Michigan, USA

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• 2 units used as needed – up to 70 beds each

• Highly experienced staff with demonstrated research experience

• Emergency units close by or in same facility

• Lab services

• Dose ranging

• PK/Biostatistics

• Newly set up 50-bed phase I unit in the state

 

Research Unit – Bucharest, Romania

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• One clinical research unit - 20 beds, expandable to 70 beds

• Emergency Unit in the same building

• Lab services

• PK/PD

• Bio-equivalence Center

 

Early Phase Unit – Warsaw, Poland

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• One clinical research unit - 20 beds, expandable

• Emergency Unit within few miles from the building

• Lab services

• PK/PD

• Biostatistics

• Bio-equivalence Center

 

Early Phase Unit – Delhi, India

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• One clinical research unit - 120 beds

• Emergency Unit in the same building

• Lab services

• High enrollment rate

• Phase I laboratory

• PK/Biostatistics

• Bio-equivalence

• First-in-man center

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Types of studies performed

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Our phase I studies offer a clear image about drug potential and benefits vs. side effects and safety. We are able offer our clients the following type of studies:

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• First-in-man (patient volunteers)

• Safety and tolerability

• Single and multiple-dose rising

• Development and use of Biomarkers

• Dose response relationship

• PK studies

• Drug to drug interactions

• Food to drug interactions

• Bio-availability & Bio-equivalence