TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT | Page 12

Operational Considerations. In emerging countries, clinical supplies
management is a complex operation that demands in-depth knowledge of
import/export regulations and supply chain infrastructure to transport time- and
temperature-sensitive drugs across challenging environments. Import/export
licenses can be costly and, in many countries, licenses are granted only after
studies are approved. Efficient supply chain operations require management of
multiple vendors. Sponsor also should be aware of regulations that affect
laboratory samples. For example, China does not allow export of laboratory
samples; all lab work must be conducted in China.
Advanced Internet-based technologies now provide integrated research platforms
that give sponsors EDC capabilities together with full access to patient data,
laboratory results and study metrics like site enrollment. Real-time data
applications to support centralized clinical monitoring and automated endpoint
adjudication systems of are particular value to reduce costs and timelines in large,
complex cardiovascular studies. EDC is standard practice across most emerging
venues. In 2012, the Brazilian government adopted an electronic platform for trial
submissions. Governments in the United States, the United Kingdom, Canada,
France, Denmark, Finland, Australia, New Zealand and other countries are
planning and implementing integrated computer-based national healthcare
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infrastructures based on interoperable electronic medical record systems. Rising
Internet use and access to mobile devices in Asia, Latin America and Eastern
Europe offer growing capabilities for electronic patient monitoring, follow-up and
health communications.