As the nature of clinical trials becomes more complex, the focus and expertise of personnel involved has become more specialized. To manage a successful study, awareness of all aspects in this process is critical.
In this audio conference, Ms. Oliver reveals all of the logistical challenges involved in clinical studies and effectively illustrates them through two scenarios: 1) drug distribution through delivery and 2) specimen transport from patient to assay.
The topics covered will include successful strategies for the transport of cold chain including regulatory and import considerations. Also discussed will be aspects of clinical sample logistics including site and lab selection, and customs.
This audio conference covers:
- Tips for successful logistics planning in global clinical studies
- Strategy for effective clinical supply shipping
- Areas to consider for timely specimen transport
- Emerging country hurdles and ways to surmount them
- Cold chain strategies including routing and import
About the speaker:
Karen Oliver For the past 10 years, Karen Oliver has been responsible for the development of value-added programs in support of global drug development. This involvement includes investigator site support, logistical guidelines for the handling of Safety Assessment material, temperature control initiatives, and hundreds of global clinical studies.
Karen has spent the last decade presenting at workshops and seminars and participating in numerous investigator-meeting presentations discussing the logistical aspects of the trials. She has worked with clinical research professionals to ascertain their needs for strategies, information technologies, and process improvement methods. Karen helps shippers, sponsors, labs and World Courier global networks by constantly evaluating services that provide technical expertise to them, such as training, Biopharm shipping, and dangerous goods and perishables.
In her various management capacities, Karen has worked in most of the biotechnology / pharmaceutical “hotbeds,” including Boston, San Francisco, Raleigh, New York, Connecticut, New Jersey, the United Kingdom and Latin America. She is a member of the American Association of Pharmaceutical Scientists, Parenteral Drug Association, Drug Information Association, and the International Society for Pharmaceutical Engineers.
Who should attend?
- Directors of Clinical Research
- Directors of Global Logistics
- Clinical Logistics Managers
- Clinical Operations Managers
- Clinical Supply Chain Coordinators
- Global Pharmacy Operations
- Regulatory Affairs Professionals
- Transportation Managers
- Clinical Research Associates
*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.