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European Pharmaceutical Contractor

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Winter 2017

   
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LIMS & Central Labs
Data Management & Analytics

Input/Output

Ankit Lodha
at Amgen explains why, with the growing importance and necessity of data management, pharma firms are moving from experience- to predictive data-based processes.
 
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Laboratory Informatics

Data-Driven


Despite the number of reporting systems available, there is no easy fix for all Ė Madhuri Tekchandani and Saakshi Shrivastava at MarketsandMarkets explore emerging tailor-made solutions.
 
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Clinical Laboratories & Logistics
Specimen Lifecycle Plan

Mapped Out


For information collection during clinical trials, LabConnectís Eric Hayashi suggests that streamlined sample management planning and the use of biorepositories are necessary to achieve optimum results.
 
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Strategic Sample Management

The Lifecycle of a Sample

Katheryn Shea
at BioStorage Technologies demonstrates the advantages of providing easy access to scientists throughout sample lifecycles in terms of data management, collections and variability.
 
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Published quarterly in
February, May,
August and November

News and Press Releases

ERT Launches the Industrys First Multi-Language Diagnostic Platform for Respiratory Trials


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White Papers

Case Study: Cmedís 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

Pharmaceutical Microbiology East Coast

13-14 November 2017, Renaissance Woodbridge Hotel, New Jersey

Drawing on from the huge success of SMiís Pharmaceutical Microbiology event series, SMi is delighted to announce the launch of Pharmaceutical Microbiology East Coast. Being the eighth in its series, this event will take place in New Jersey, USA, on November 13th and 14th 2017. Aimed at Microbiologists, Quality Control and Quality Assurance Managers, Pharmaceutical Microbiology East Coast 2017 will address the best practices for rapid microbial and sterility testing and tackle the challenges of contamination control.
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