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European Pharmaceutical Contractor

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Spring 2016

   
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Marketplace & Business
Pricing and Market Access

People Skills


According to a-connect's Aunia Grogan and Claire Hempshall, it is vital to establish and maintain access to drugs in an evolving environment, which is characterised by tight budgets, shifting market trends and new therapy areas, among others.


 
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Marketplace & Business: Translation Feature
Translation Tools

Lingua Franca


Translation technology has grown in conjunction with the increasing number of clinical trials carried out globally. Trevor Korb at Corporate Translations wonders how these new tools can aid pharma.

 
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Legal & Regulatory
Clinical Evaluation

Conform to the Norm: Part 2


Continuing from EPC February, Terry Winchell at GCP Innovative Dynamics further elaborates on current regulations concerning clinical investigator disqualifications, and shares practical advice.

 
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Electronic Solutions
Patient Communication Technology

Talk Technical


Dr Mark Hooper at Conversis Medical Translations observes how technology has an impact on nearly all areas in the pharma industry, and that patient adherence, communication, enrolment and retention can be improved as a result.

 
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Medical Writing
Medical Writing Metrics

Do You Measure Up?


There is a pressing need to measure the performance of service providers for evaluation purposes, states Trilogy Writing & Consulting’s Dr Julia Forjanic Klapproth, while emphasising that metrics for medical writing are not simple to establish.

 
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Interview
Q&A: Electronic Patient-Reported Outcomes

Digital Approach

John Sage
at iCardiac tells EPC about the increasing demand for ePRO technologies, which opens up significant growth opportunities for developers of such innovations.

 
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News and Press Releases

With Help of DC-Based FDA Consulting Firm, Baltimore Nonprofit Helps Minority Students Achieve Careers in STEM Fields


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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

7th annual Orphan Drugs and Rare Diseases UK

18-19 October 2017, Holiday Inn Kensington Forum, London

SMi Group is thrilled to present the 7th annual Orphan Drugs and Rare Diseases conference, taking place on 18th & 19th October 2017 in Central London, UK. This year’s theme will be focused towards discussing strategies for patient engagement, market access and gene therapies to enhance rare diseases and orphan drug research.
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