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European Pharmaceutical Contractor

epc
Summer 2018

   
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Clinical Development
Biomarkers in Clinical Research

Innovative Indication

The benefits of using biomarkers to aid clinical research and data collection are demonstrated by Professor Christene Leiper at Onorach as attention to their use continues to grow.
 
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DATA MANAGEMENT
Subjective Measurements in Dermatology Clinical Trials

A Blemish on Good Science

Bias is a topic that continuously appears throughout clinical trials. Dr Elisabeth Rowold at Novella Clinical suggests that research into data collection strategies can provide reliable and objective data for studies.
 
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Clinical Data Management

Monitoring and Managing

Praveen Dass at Quanticate provides a comprehensive explanation on how an effective critical data management strategy can drastically enhance clinical trials through results, costs, and timelines.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Peli BioThermal Key Speakers at CTS Europe

Peli BioThermal, the global name in temperature controlled packaging, will highlight the rise of reusable temperature controlled packaging as guest speakers at Clinical Trial Supply Europe, being held in Milan on March 13 – 14, 2019.
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White Papers

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

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
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