Service Description

ICON was contracted to deliver Western European sites to a w/w Ph3 oncology study. They contacted over 100 sites and opened about 80%. Overall study start-up was competent with some timeline slippage. CRA performance was weak as training was clearly not up to date, resulting in multiple communications on the same issue. Efficiency rating was 6 out of 10 leaving plenty of room for improvement. Project management was of moderate quality but motivated. Staff transitions were poorly handled esp. mid-study. However, that was compensated by strong second and third layer of staff starting with a motivated project manager. Overall positive experience but clearly not a top tier performance on this project.

What Went Well

Duplication of query replies between CRAs and project manager. Could benefit by a better logging system to facilitate client review and approval starting with standard email headers to allow group query follow-up. Study start-up team was competent, but contract and budget negotiations could benefit by country-specific templates. Deviations from template whether budgetary or legal should be marked to facilitate client review and approval. Study initiation visit documentation has become voluminous at the expense of the purpose of SIV which is to ensure site compliance with protocol requirements. Worked well but could use improvement.

What Could Be Improved

Improved SIV documentation focusing on site education with the goal of speeding FPI and minimizing queries from site. Handle staff transition with more advanced notice and ensure that staff proposed for client approval meet client specifications from the original work order documents. Facilitate client review and approval of start-up aspects by creating standard country legal & budget templates, clearly showing deviations on a site-by-site basis.

Lessons Learned from the Experience

No, they were competent in terms of study start-up across a large number of countries, but had minimal therapeutic area knowledge to substantively improve site compliance and match eligibility requirements. This lack of familiarity resulted in a large volume of queries for the sponsor staff which reduced the outsourcing value of the CRO contract. In future studies would consider parsing assignments more precisely in order to avoid generation of large volume of traffic without impact on site compliance. CRO staff were not trained and possibly not rewarded for thinking out of the box. It was left to individual initiative to handle problems as they arose. Clearly, more can be done in terms of training and empowerment to help staff become more confident and proactive in problem-solving.