European Pharmaceutical Contractor |
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| At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in the current issue of EPC. |
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| Recognising the high costs of clinical research and the demand for rapid advancements, John Paul at Frost & Sullivan examines the benefits of outsourcing strategies for organisational success, in As the CRO Flies |
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| In A Passage to India, IndiPharm’s Edward J Brennan recommends cutting
costs and increasing productivity by relocating clinical trials to the latest
pharmaceutical frontier |
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| Nacho Mbeliachi at Healthcare Project Management asserts that the business expansion rates of CROs will have a positive effect on the future of the medical writing agencies that are Gunning for Growth |
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| Adding contract design services is not a short-term strategy but a Design for Life, concludes Eric Resnick at The Tech Group, examining its cost and capability advantages for contract manufacturers |
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| Current trends suggest research outsourcing is set for a dramatic increase in the years
ahead. In Asian Allstars, TS Jaishankar of Quest Life Sciences examines the pros and
cons of expanding business into the Asian region |
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| Rapid advancements in regulations have resulted in a new Mexican Twist within the pharmaceutical industry. Christopher Davies of Pharmalink Consulting assesses dramatic improvements for the leader of the Latin American market |
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| In the light of adverse cardiac drug reactions, Jean Barbey of Medifacts International demonstrates, in Skipping a Beat, the importance of accurately measuring QT intervals during clinical research |
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| Amy Furlong at eResearchTechnology, Inc highlights the vital characteristics at the heart of an effective ECG digital data management system, in Quality to the Core |
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| The future of clinical studies may lie in the growth potential of adaptive designs. Analysing the statistical design procedures of the planning stage,Thorsten Reineke at MSOURCE considers sample sizes and The Laws of Adaptation |
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| Collaborative efforts between sectors of the pharmaceutical industry are Building Foundations for innovative technical documents. Jeffery J Bowden and Frank Dunn at Biomedical Systems evaluate the future of medical imagining standardisation |
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| Discussing novel responses to new regulatory requirements, Jim Nichols at Thomson
Scientific maintains that the core of new integration strategies should be Connecting
the Dots of isolated data points and refining the management of regulatory affairs |
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| With clinical outsourcing gathering momentum in the globalised drugs arena,
Sabine Richter of PRA International emphasises the requirements of an effective
pharmacovigilance service and presents the Best Practices to Ensure Success |
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| In a bid to clarify who will be first to cross The Finnish Line, Hanna Paloheimo
at Borenius & Kemppinen analyses Finland’s complex inventions legislation |
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| The media reports tort claims resulting from adverse pharmaceutical effects on
both sides of the Atlantic, but Darren Smith and Heather Ritch at Reed Smith
Richards Butler LLP compare A World of Difference between litigation results
in the US and the UK |
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| Examining The New Penalties Regulation for infringements, Elisabethann Wright and Susan Jane Clements at Hogan & Hartson reveal the complex debate surrounding breaches of marketing authorisation |
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| Dr Jenny Gebhardt of BPI Service GmbH and Gloria Cenni of Bassilichi Spa describe the application of standard validation processes to vital pharmacovigilance software, in Joining Forces |
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| Gaining Access to new medicines in trials is a vital concern for critical patients. Angus G Cameron of BR Pharma Limited investigates the life-enhancing benefits of compassionate use and named patient programmes |
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| In Moving Beyond Recruitment Barriers, Julie Ross of Essential Group, Inc considers the enrichment of enrolment programmes through empowering potential trial subjects to seek participation in clinical studies |
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| As offshoring becomes increasingly the norm in clinical trials, companies are turning to the ample medical resources of the former USSR. Vladimir V Novakovskiy at Congenix, LLC outlines the region’s study management potential in From Russia with Success |
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| Wade Wirta of Perceptive Informatics claims that IVRS constitutes an important tool for the clinical trial process in the competitive drive to reduce drug supply costs and improve risk management, in Voicing Demands |
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| In Keeping Cool, Geraint Thomas at Laminar Medica emphasises the crucial importance of adequate control measures in the transport of temperature-sensitive materials, and its implications for clinical trial success |
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| In an industry constantly demanding condition-critical shipment of dangerous goods, proper packaging is essential. In his review of specifications and label changes, Jay Johnson at Inmark opines that Handling Hazards doesn’t have to be a risky business |
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| In A Marriage of Convenience, Dr Andrew Reason of M-Scan Limited and Stéphane Canarelli and Dr Bernard Ludwig of M-Scan SA examine the development of molecular peptides for therapeutic use and recommend the effective union of chromatography and tandem-mass spectrometry |
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| Fixing Form and Formulation for Phase I is essential in determining the suitability of new drug compounds. Paul Fagan of Aptuit offers strategies that ensure poorly soluble candidates reach early clinical stages |
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| The growth of international collaboration in large-scale clinical research networks demands the data-sharing capabilities of Image Integration solutions, claim Dr Robert Modre-Osprian and Dr Günter Schreier at Austrian Research Centers GmbH |
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| Peter Reynolds of Image Solutions, Inc considers the dynamic adoption of eCTD processes to improve productivity, in Opening the Door to Change |
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| Generic LIMS systems need a boost to adapt to the laboratory environment, claims Jørn Christensen at LabWare – There’s no LIMit to the additional function of new-generation LIMS |
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