White Papers

Operational Similarities and Differences : USA VS EU

Given the globalization of the biopharma industry, consorting the drug regulatory environs of the United States of America (USA) and European Union (EU) are getting more and more important to fasten the development of new curatives.

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Considerations in RBM Implementation

In this 5th Edition of Applied Clinical Trials' eBook on Risk-Based Monitoring in Clinical Trials, articles cover the advances that have been made in RBM since guidances' released in 2013. How is pharma implementing RBM - is it more remote, centralized or a combination? Read the article by Dr. Ashok Ghone, Vice-President, Global Services at MakroCare:Considerations in RBM Implementation

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CER : new MEDDEV 2.7.1 REV 4: Why is This More Complex Now

In July’2016, the EU has published Rev.4 of MEDDE V2.7.1 on clinical Evaluation for medica l devices.The new guidance document describes the requirement in a more detailed

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Central Monitor: A Key Driver of Centralized Monitoring, published in Applied Clinical Trials

Centralized monitoring offers many of the capabilities of on-site monitoring as well as additional capabilities. With the advent of various eClinical technologies, analytical and visualization tools.

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An Article published by RAPS: SouthEast Asian Regulatory Environment for Pharmaceuticals Part -I

This Study attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets of Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia.

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