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| home > white papers > Technology Solutions - Driving efficiencies, quality and operational excellence - Worldwide Clinical Trials Ltd |
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 WHITE PAPERS |
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Worldwide Clinical Trials Ltd
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Technology Solutions - Driving efficiencies, quality and operational excellence
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Clinical trials involve the entry, analysis and reporting of millions of
pieces of data; year-on-year, the amount of data required to manage
efficacy and safety increases exponentially. Recently, solutions
available to support this activity have grown in numbers and complexity.
The rise of Tablets and Smart Phones combined with the growth of Cloud
or SAS solutions has resulted in the technology landscape required to
support complex, global studies becoming more confusing.
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News and Press Releases |
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3P Biopharmaceuticals receives FDA approval
[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
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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.
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Industry Events |
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PPMA Total Show
1-3 October 2019, Birmingham
About PPMA Total Show
PPMA Total is one of UK’s largest processing and packaging
machinery exhibitions. Building on the success of the PPMA Show in 2018,
PPMA Total returns to the NEC, Birmingham, on 1-3 October 2019 for
another show-stopping event.
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