Clinical Trial Agreement Negotiations

There are opportunities to make the negotiation process more efficient and reduce timelines
Jun 01, 2012
By Applied Clinical Trials Editors
Volume 21, Issue 6

Translations. In many countries, site agreements need to be translated into the local language, sometimes only for information purposes, sometimes because it is a legal requirement or because the site is not willing to sign a contract in another language.

A CRO and a sponsor of a clinical trial often agree on a certain policy with respect to translations. Entire templates and larger pieces of text in an agreement under negotiation are usually translated by certified translators while small parts are often translated by local clinical staff into and from their native language. This approach is a pragmatic one; however, small words can make a considerable difference in legal meaning. Therefore, it might be prudent to consider using a certified translator in all cases except for purely administrative parts such as names and addresses.

Proper translations of the contracts are important not only because of the risk of committing to contents that one did not intend to, but also because unnecessary delays may occur. For example, a party may reject certain terms that would have been absolutely acceptable to that party, had they been properly translated.

The majority of the respondents to the survey indicated that they use certified translators for the translation of their agreements (almost 60%), but not even 30% seem to use translators with experience in the industry. In order to avoid the above-mentioned risks, it is important to make use of translation agencies that are very familiar with the terminology in the industry. For example "subject" may be translated to "topic" in the local language, although clearly a study participant was meant by the term.

Eventually it is important to create a balance between being pragmatic and proper risk management: the lawyer or contract managers can help decide which parts are important enough to run by a certified translator. Ensure the translator has experience in both industry specific and legal terms.

Conclusion

Contract negotiations with hospitals and investigators are time-intensive. However, there are still many areas that present opportunities to make the negotiation process more efficient, reduce timelines, and at the same time maintain a proper risk and quality standard.

Realizing the potential high costs involved with unnecessary risks, inefficiencies, and (especially) delays, and given the situation that CROs, pharmaceutical, and biotech companies are increasingly forced to make their decisions on the basis of cost efficiencies, it seems only evident that it is worthwhile to invest in experienced and qualified staff and/or to contract external resources that possess the required experience and skills. Improving clinical trial agreement negotiations is an opportunity to be seized.

Myrthe Rijswijk-Trompert is CEO and Senior Legal Consultant at Salvius Legal, Salvius Legal BV, Karpervijver 12, 3703 CJ Zeist, The Netherlands, e-mail:
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References

1. Mary Jo Lamberti, ed., "State of the Clinical Trials Industry A Sourcebook of Charts and Statistics" CenterWatch (2008),

2. C. P. Adams and W. Brantner, "Estimating the Cost of New Drug Development: is it Really 802 Million Dollars?" Health Affairs, 25 (2) 420-208 (2006).


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