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European Pharmaceutical Contractor

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Summer 2014

   
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Marketplace & Business
CRO Marketplace

Value Added

Adam M Dion
at GlobalData suggests that accomodating a diverse range of clients is the best solution to challenges facing contract research organisations - companies are now offering new services to increase revenue and appeal to firms which are set to lead future innovation.

 
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Process Management Systems

Business Growth


Improving process management is always worthwhile, whatever a company’s goals. Richard Holland at TBM Consulting says renewing your system could be the key to greater efficiency, long-term reliability and continuous productivity.
 
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Legal & Regulatory
Clinical Trial Regulation

All Change


Recent updates to EU clinical trial regulation will impact many areas of drug development, says ICON's Daphne Smyth. Among the benefits of the changes are quicker access to treatments and streamlined legislation across member states.

 
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Drug Approval

The Right Path


With the ever-present need for greater efficiency and lower costs, Ken Phelps at Camargo Pharmaceutical Services explains why some companies are turning to the 505(b)(2) pathway, which opens up a quicker, less expensive drug development route.

 
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Intellectual Property

Added Protection


A good understanding of intellectual property protection can deliver increased revenue and the ability to tap into market niches. However, applying initiatives is a complex task, argue Victor Caddy and Lyndsey Lynch at Wynne-Jones IP.

 
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Outsourcing Regulatory Affairs

Safe Strategy

MakroCare’s Mahesh Malneedi
describes the best strategy to implement when choosing to outsource regulatory affairs. He recommends devising a risk-averse plan and selecting a firm with varied offerings.
 
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EU Pharmacovigilance

A New Mindset


The full impact of the pharmacovigilance updates of 2012 is yet to be seen, believes Doris Stenver at the Danish Health and Medicines Authority. She suggests that the revisions will eventually lead to a whole new way of thinking.
 
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Therapeutic Innovation
Vaccine Formulations

New Potential


The new development of solid state circular dichroism goes beyond traditional vaccine analysis. Allan Watkinson and Jan Vos of XstalBio explain how this technique can offer a deeper understanding of formulations.
 
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DATA MANAGEMENT
Serialisation Programs

Bigger Data


Ramesh J Chougule of Infosys explains how implementing a new serialisation program – and moving away from traditional data tracking methods – can translate into improved efficiency, precision and cost-saving.
 
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STAFF RECRUITMENT & TRAINING
Competence Verification

Standard of Care

Martin Robinson
at the International Academy of Clinical Research outlines the findings from a recent report highlighting the need to readdress patient requirements and increase the public's protection. He reasons that competence verification could remedy the issues.


 
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Clinical Laboratories
Microbiological Testing

The Central Issue


Deciding on the most suitable type of laboratory for the microbiological stage of a clinical trial can be problematic. PSI CRO's Andrey Karelin, Maxim Belotserkovsky, Veronika Khokhlova and Olga Sazonova outline the various considerations

 
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Cool Chain, Labs & Logistics
Cold Chain

Evolving Markets


Stephen Healy at Intelsius demonstrates why emerging markets possess the greatest opportunity for market growth, and how they could contribute to a supply chain evolution.
 
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Interview
Industry Interview

Better, Faster, Stronger


Helping customers accelerate research progress is the most rewarding part of Jim Carroll’s role at iCTRS. Here, he tells EPC how to get ahead when reducing patient enrolment timelines.
 
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Industry Interview

Data Driven


Elizabeth Brooks at Decision Driver Analytics speaks to EPC on why business decisions should be approached with a rigourous and practical view, while being driven by analytics.
 
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News and Press Releases

High Throughput Analytics Herald a Paradigm Shift in the Development of Biopharmaceuticals

Heilbronn/Dortmund August 2019: Biopharmaceuticals have revolutionized therapies of various diseases. In particular with regard to chronical and/or severe clinical conditions like multiple sclerosis, rheumatoid arthritis or cancer they are considered the future of treatment. Also economically biological drugs are on their way up: The global biopharmaceuticals market is anticipated to reach about 400 billion USD by 2025. Which strategic alignment will help best to fill a successful pipeline?
More info >>

White Papers

Conveying Medical Guidance in Clinical Trials – A Survey

Europital Medical Consultancy

With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
More info >>

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
More info >>

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