Summary of Day 2 Part 2 #SCOPE2014

Recap of Wednesday Afternoon at SCOPE – February 5th, 2014

Thank you for reading part 2 of the day 2 summary of sessions for Summit for Clinical Operations Executives (SCOPE) conference.

Previously Posted Re-caps

Day 1, February 4th, 2014
Day 2, AM sessions

Wednesday Afternoon ‘Improving Site Performance’

Adam Chasse of RxTrials (a fellow blogger!) our chair, encouraged industry to help sites deliver in opening remarks. To paraphrase: In 1995 two amazing technologies improved the way we do our work, Word Perfect introduced track changes for document revisions (related blog post) and inbound emails from outside organizations were allowed through his company firewall…outside of that (nearly 20 years ago), pharma hasn’t done the best job of embracing other new technologies. Contracts still sit on desks and we often pick the wrong battles during negotiation with our sites leaving them feeling alienated and unsupported.

Beth Harper continued the theme of investing in site support by offering solutions on how to better engage trial sites. Sponsors can stay “top of mind” through easy touchpoints like published ‘tips of the week’, ‘fast focus’, or ‘did you know’ email blasts. How about including the lab techs and the pharmacist on study communications or training events? Include site personnel as presenters and experts for training webinars – showcase their contributions. Create job-aids to translate all the ‘Schedule of Assessment’ footnotes (13 currently in size 6 font on the one your author, Nadia signed off on today…). In a previous study my team set up a triage circuit line that would round-robin ring every study team member until answered; sites loved it and Beth suggests this, too. Beth says we would be well-served to “make multiple small deposits in the relationship bank before withdrawal (requests and extra demands of the site personnel).” I agree and this can be critical to obtaining the responses and performance you need in “crunch time.” I gave a very similar presentation at the Arena Outsourcing conference in 2012 (session summarized previously on the ClinOps Toolkit) so Beth’s talk really resonated with me.

Site Selection

Nye Pelton of Eli Lilly Neuroscience division in North America delivered a convincing talk on global enrollment strategy. At Lilly, the COPM knows of trials at least 6-18 months in advance. This field-based team can plan successful enrollment strategies by starting with the question, “what would good look like?” Working backwards from a vision of perfectly optimized operations, his team will map out individual trial strategy for site selection.

Integrated Trials: Unified Platform

Lisa La Luna VP at ePharmaSolutions advocated data and technology to improve training, feasibility, start-up, recruitment, more training, etc. The beauty of ePharmaSolutions platform is user provisioning and integrated/bridged sites with single sign-on. Over 300,000 users have access to portal and application features including a centralized task manager. Lisa reports 29% faster feasibility. The audience had to know, could Transcelerate initiatives be an integrated app? yes. What are site impressions? Lisa says it all depends on the rollout and she acknowledges challenges to deploy in hospital settings and geographies such as China.

Break for SCOPE Networking

Networking on the exhibitor floor

Networking on the exhibitor floor: FOCM

Supporting the Bay Area SCOPE Delegation

Next I snuck over to the Clinical Trial Forecasting track to rally behind the San Francisco Bay Area home team. Lisa Sergas, Clinical Outsourcing at Medivation highlighted many “must ask” questions when working with CRO partners including:

  • Do vendors have capacity/scalability/ability to change processes mid-study? per-study?
  • How will you measure the work and performance?
  • Will you institute preferred partnerships?
  • If things are going well, do you reward with more work or are you too concerned about maxing out resources?

I took so many notes at this session that I am going to just save them for another post (Lisa you have a standing invitation to contribute anytime) to analyze the benefits/risks for niche CROs vs. the big global CROs. Lisa reiterated that the process of managing multiple CROs can be overly complicated and demanding on resources.

Panel Discussion: Do You Want to be the Sponsor of Choice?

Deborah Manzo from Abbvie, Jamie MacDonald from Centers of Excellence site network, and Silvana Giustino of Eisai delivered an excellent panel discussion on the topic of engaging trial sites. This group prefers building relationships vs. waiting and salvaging. Pharma leadership that values expert soft-skills in their organization will “win the business” of working with the best sites. Very little can overcome an unlikable/poor protocol but, as sponsors, we can at least set the right expectations and be forthcoming in feasibility; partnering from the start in a “trusting and arranged marriage”.

A Forecast to Conclude Summary Series?

This brings us to the third and final day of #SCOPE2014 and I’ll start that summary tomorrow. Highlights from the plenary keynotes and stand-out sessions will follow. I am resting now and then taking a free day to 1) finally sleep in and 2) nosh some deli goodies and 3) go on a leisurely Miami photowalk. Today’s conference finale was so inspiring (although the shortest day of the event) that I took more notes than the first two days combined. I will organize into a summary series as needed to curate the best for you. Thanks for sticking with the series. How about leaving a comment now? I’d love to hear your thoughts and impressions.

Full Scope 2014 Summary

Previously Posted

Day 1, February 4th, 2014
Day 2, AM sessions
Day 2, Part 2 (this page)
Day 3, Plenary Keynotes
Day 3, Final Sessions

About The Author

Nadia

Nadia Bracken, lead contributor to the Lead CRA blog and the ClinOps Toolkit blog, is a Clinical Program Manager in the San Francisco Bay Area.