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Page 43

Clinical Pharmacology & Biopharmaceutics | ISSN : 2167-065X

Volume 7

September 18-19, 2018 | Amsterdam, Netherlands

6

th

European Biopharma Congress

Euro Biopharma 2018

Essential considerations for selecting clinical research organizations (cross): Pragmatic guidance for biotech companies

based on case-studies in Europe, Japan, and the US

Hiroko Tadano

Trans World Clinical Alliance, Netherlands

S

enior management in biotechnology organizations span the gamut of industry expertise from deep academic and research backgrounds

to corporate, global biopharma skills, and everything else in between. This internal collective corporate experience and history often

drives how a clinical research organization (CRO) partners are eventually selected, and often without considerations to other key imperative

elements that determine the best fit, for the immediate as well as the long-term needs of a clinical development program. The presenters will

utilize case-study examples from biotechnology companies in Europe, Japan, and the US to describe how biotechnology companies can

increase their chances of success in choosing an appropriate external clinical development partner. Understanding where blind-spots often

occur, how to navigate internal corporate mind-sets, and individual biases will be discussed through case-examples. Various approaches and

solutions will be highlighted, and specifically tailored for the small- to mid-size biotechnology companies. The presenters will also discuss

critical issues in the selection process such as fees, deliverables, timelines, and managing disappointments.

hs@lumisinternational.com

Clin Pharmacol Biopharm 2018, Volume:7

DOI: 10.4172/2167-065X-C1-029