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PAREXEL

phone +1 781 487 9900
web http://www.parexel.com/
email 195 West Street, Waltham, MA 02451

Running Smarter Trials With Data-Driven Monitoring

Clinical monitoring remains one of the most important and most costly activities in the clinical research paradigm.  Monitoring provides the operational transparency required by investigators, sponsors, and regulators to make informed decisions about site performance, patient safety, and overall study progress. Yet unlike many clinical trial activities, which have been steadily transformed by technology, the monitoring function itself has changed little.
Running Smarter Trials With Data-Driven Monitoring
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News and Press Releases

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

Faster, Better, Cheaper: Lean as a Driving Force Behind Pharmaceutical Companies’ Growth

TBM Consulting Group

The pharmaceutical industry faces countless challenges: patent expirations, weak product development pipelines, downward pricing pressure and an increasingly burdensome regulatory environment. The most important question for companies is now “How can we position ourselves optimally to be successful in the long term?” Some pharmaceutical companies used the economic downturn in 2009 to embrace measures in the fields of cost reduction and efficiency increases, which can be implemented at short notice. The continuous and consistent implementation of sustainable measures that guarantee stability and form the basis for future growth was not necessarily paramount within this.
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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
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