Articles
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Case Study: Recruitment Expertise Reduces High Screen Failure Rate
5/11/2011
The Quintiles team developed a profile of patients who would be more likely to fulfill criteria and distributed it to sites.
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Targeting Oncology
5/11/2011
In the search to improve cancer outcomes, each promising advance across the biopharmaceutical frontier comes with challenges as unique as the specific molecular pathway and individual genetic profile it targets.
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Case Study: Advanced Prostate Cancer Phase III Study
5/11/2011
Two studies sought to evaluate the efficacy of the 15mg 4-month formulation or 22.5mg 6-month formulation in achieving castrate levels of testosterone (=1.735nmol/L) on Day 29 (i.e., 28 days after study drug injection).
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A Focus On CNS (Central Nervous System)
5/11/2011
Today, developing differentiated drugs that deliver demonstrable patient benefits and added value is more challenging than ever.
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PK/PD Modeling And Simulation Optimization Tools
5/11/2011
Quintiles has a wealth of experience in population PK/PD modeling and simulation.
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Advancing Vaccine Development
5/11/2011
With extensive experience in vaccines development, as well as market access and commercialization strategy, Quintiles is uniquely qualified to be your ally in vaccines.
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Early Clinical Development Solutions
5/11/2011
In the New Health, where competition and technology are driving rapid change, dollars and potential delays matter more than ever. Making the right decisions in early development is critical to the success of your portfolio.
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Improving Pharmaceutical Manufacturing Regulatory Risk
3/15/2011
Pharmaceutical manufacturers must manage regulatory risk to ensure products are developed and produced in manner consistent with organizational goals and strategic objectives. Ongoing operations and marketplace supply can be hindered if a producer is not keenly aware of the regulatory environment and potential risks of underperforming processes. Operational requirements for development of clinical supply may also be adversely affected when regulatory issues exist. Similarly, drug development may be hindered by poorly performing production processes for managing laboratory testing, facilities and systems, quality and packaging/labeling. By ACSYS, Inc.
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White Paper: Reducing Clinical Regulatory Risk For Drugs, Biologics And Devices
6/1/2010
Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. By ACSYS, Inc.
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Reducing Clinical Regulatory Risk For Drugs, Biologics And Devices
6/1/2010
Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. By ACSYS, Inc.