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| home > white papers > Clinical Trials in Russia Orange Paper: Summary of Year 2013 - Synergy Research Group |
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 WHITE PAPERS |
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Synergy Research Group
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Clinical Trials in Russia Orange Paper: Summary of Year 2013
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Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials.
Sponsors mention the following reasons for conducting studies in Russia:
1. Fast patient enrollment due to the centralized medical infrastructure.
2. Nearly 100% patient retention
3. GCP trained and certified Investigative Sites generating high quality data
4.
Low cost: Average per patient cost is 60% to 70% below US and European
prices due to the low cost of Investigators and the high concentration
of patients in therapeutically aligned medical centers
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News and Press Releases |
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European Medicines Agency Commences Review of Aripiprazole 2-Month Long-Acting Injectable for the Maintenance Treatment of Schizophrenia in Adult Patients Stabilised with Aripiprazole
LONDON, UK, 17 June 2022 – Otsuka Pharmaceutical Europe Ltd.
(“Otsuka”) and H. Lundbeck A/S (“Lundbeck”) today announce that the
European Medicines Agency (EMA) has accepted the Marketing Authorisation
Application (MAA) for aripiprazole as a 2-month ready-to-use (RTU)
long-acting injectable (LAI) for the maintenance treatment of
schizophrenia in adult patients stabilised with aripiprazole.
More info >> |
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White Papers |
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Case Study: Cmed’s Mobile Data Management Solution
Cmed Clinical Services
The trial presented to Cmed was a randomized, double blinded, placebo
and active controlled study to evaluate the cardiac safety of multiple
doses of [study drug] in health volunteers.
The pharmaceutical
company, who were into the second year of development of a potential
blockbuster compound for the treatment of chronic myelogenous leukaemia
(CML), were requested by the FDA to design a trial to provide
information on the cardiac safety of different dose levels of the study
drug in healthy adult volunteers. The primary objective of the study was
specifically to find the maximum tolerated dose before QTc levels
became unsafe. All development of the compound was put on hold until the
results of this study were submitted to the FDA and approval granted
for the compound to progress into full development.
More info >> |
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