Going green Next Generation Pharmaceutical (Europe)              Collaboration and innovation Next Generation Pharmaceutical (Europe)              Pushing the frontiers of disease prevention Next Generation Pharmaceutical (Europe)              The power of perception Next Generation Pharmaceutical (Europe)              Supply chain optimisation Next Generation Pharmaceutical (Europe)              Translational medicine paradigm: hip or hype? Next Generation Pharmaceutical (US)              The evolution of drug safety Next Generation Pharmaceutical (US)              Investigating cell death resistance in tumor cells Next Generation Pharmaceutical (US)              A culture of engagement and inclusion Next Generation Pharmaceutical (US)              Leading Lilly forward Next Generation Pharmaceutical (US)             

Contributors

John Lechleiter
John Lechleiter
COO, Eli Lilly
Leading Lilly forward

Ken Murtha
Ken Murtha
Regional VP Supply for the Americas, AstraZeneca
The importance of operations

Jill Robinson
Jill Robinson
VP of Global Safety Surveillance, Wyeth Research
The new risk management paradigm

Mary Ellen Turner
Mary Ellen Turner
VP Risk Management, Wyeth Research
The new risk management paradigm

Dr. Andreas Busch
Dr. Andreas Busch
Head of Global Drug Discovery, Bayer Schering Pharma
Big in Germany

Tracy Lefteroff
Tracy Lefteroff
Price Waterhouse Coopers
Looking to the future

Clinical Trials

The field of clinical research is beset with dwindling patient populations and decreasing retention rates. Finding the right partners to conduct all phases of a clinical study is the final and most important stage in bringing a new drug to market. Achieving success at this stage translates immediately into the approval of cutting-edge treatments to diseases, thus reaping the rewards of efforts, years and billions of dollars invested in the long journey of discovery and development.

Compliance with international laws, informed voluntary consent, access to diverse patient populations, targeting new investigative sites, clinical monitoring and study design are some of many variables that need to be factored into this process. The integration of technological tools that allow for digital data capturing and real-time reporting can speed up a trial significantly, while fulfilling all the requirements of the parties involved.

Pharmaceutical sponsors seek out CROs and organizations that can help them overcome the hurdles of the clinical research process by increasing awareness of all potential benefits and risks of participation to both physicians and patients. Ultimately, the impact yielded on human health is visible in the access provided by clinical studies to patients that are knowing and willing to become a part of the process.

Testing times for human research
How the pharmaceutical industry is striving to attract and retain volunteer patients for clinical trials. By Julian Rogers
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Evaluating Challenges to Clinical Trial Execution
Evaluating Challenges to Clinical Trial Execution Garrett D. Smith, Accelovance, Marketing & Patient Recruitment
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The impact of new media on patient recruitment
As sponsors rely more heavily on the web for clinical trial patient recruitment support, Mary Schwarz, Vice President of New Media at leading patient recruitment and retention firm MMG
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Revolutionizing Patient Recruitment Through Cross Referring
Everyone talks about how much more efficient a properly executed centralized patient recruitment process is over traditional patient recruitment methods.
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Taking Trials Home
Timely patient enrollment remains the Achilles heel of drug development.
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Maximizing randomizations through referral response
Lost-to-follow-up is one of the greatest correctable barriers to completing clinical study patient enrollment
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Safety reporting in clinical trials
There’s no time to wait, say Sentrx’s Ralph Bobo and Jill Notte.
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'The Protocol Is At The Heart Of Every Clinical Trial'
The protocol is used in selecting investigative sites and designing the data collection tools; it describes how to treat and evaluate the trial subjects; it serves as a reference for monitoring and auditing trial conduct, and it conveys the plan for analyzing the data when the study is complete.
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Safety reporting in clinical trials: no time to wait
With the intense focus on drug safety, sponsors should separate the time-sensitive process of suspected unexpected serious adverse reaction (SUSAR) reporting from the long-term process of clinical data management.
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The ePRO evolution
Kurt Mussina is Vice President of CRF Inc. He has over 17 years of experience spanning Research, Marketing and International Business Development in the Pharmaceutical and Contract/Clinical Research Organization (CRO) industries.
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The perfect partner
As more companies try to establish profitable relationships with external clinical research experts, we asked Wyeth’s Ira Spector what companies should look for in their ideal match.
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Looking beyond EDC
The global pharmaceutical industry is poised at the cusp of a new phase in clinical development. The convergent forces of emerging technology, financial pressure, and consumer demand are compelling our industry to carry out drug development faster, better and cheaper.
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Pharma with a big I
In a move that is confirming its commitment to provide transparency of clinical information, the IFPMA is to launch a new internet search portal for clinical trials information. NGP spoke to Director General Harvey Bale to find out more.
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Trial without error
We look at how, through a combination of interactive technology, support and experience, each of the major challenges of a global clinical trial can be addressed.
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The Publication COVER: Next Generation Pharmaceutical 12

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Sponsors

Vendor Perspectives

Article
The iuvo Microconduit Array (MCA)
BellBrook Labs
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Article
The Top 3 Grid Application Areas for Pharma R&D: Drug Discovery, Clinical Analysis and Data Management
Univa UD
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Article
4plex, real-time one-step RT-PCR without optimization
QIAGEN
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Article
View from 37,000 feet – weathering change in the Pharmaceutical Industry
Triligent International
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Article
Moving beyond rote case reporting: demonstrating a believable commitment to patient safety
ArisGlobal LLC
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Article
Coping successfully with changing regulations in Experimental Clinical Pharmacology (Phase I)
Simbec Research Ltd
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