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Key Takeaways from SCRS 2018

Not able to attend the Site Solutions Summit 2018? Interested in finding out who won our Mexico Sweepstakes Raffle? Read Team CRIO's key takeaways from SCRS 2018.

10/19/2018 | By Kristen Bosse, Project Manager; Phoebe Stoye, Marketing Manager; Anna Krauss, Project Manager |

eSource, CTMS

Team CRIO had a blast in sunny Boca Raton, FL at the Site Solutions Summit 2018!

waldorf astoria hotel florida

We loved meeting current clients face-to-face and discussing all things eSource and CTMS with potential new #TeamCRIO members interested in going paperless. We were also fortunate this year to have the opportunity to attend many of the breakout sessions and symposiums. If you were not able to attend SCRS 2018, or just want to read our post-conference musings, read on to learn the key takeaways from SCRS 2018!

Kristen's Takeaways SCRS 2018

kristen

Communication with Sponsors is Make or Break

At my time at SCRS, I attended two classes: Building Better Budgets: Improving Negotiations & Relationships with Sponsors, and Beyond Recruitment: Utilizing Quality and Performance Metrics to Boost Your Site.

Across both classes, there was one main question that stood out:

What makes my site more attractive to sponsors?

The sponsor relationship is an ever-important factor for sites. Effectively communicating and negotiating with your sponsor is often what secures your site's trials and a position as a site of choice.

When it comes to negotiating the budget and working with the CRO/Sponsor to get to your bottom line, the sponsor cares about speed and evidence of consistent processes. For example, keeping a database of your previously negotiated rates (whether it was with this sponsor, or another) and presenting them upfront shows that you are organized, which increases your chances of getting the rates accepted more quickly. Standard documentation is very powerful; presenting these to the Sponsor will set the stage for an efficient negotiation process. Sites should have a negotiation model that they go back to every single time. Not only does this help you move faster, but it allows you to keep track of successful strategies to reuse in the future.

Once the budget is finalized, sponsors will want to see this efficiency carry through to the duration of the study. For example, how long does it take you to turn around reg docs? How fast are you screening your first patient after your SIV? How long does it take you to enter data into EDC? How long do you take to respond to queries?

All of these metrics will be tracked by the sponsor, and should be tracked internally to allow for future improvement.

The ultimate goal is to run a successful trial with quality data.

Sites that hit target enrollment in a timely fashion and maintain quality data across their subjects are going to be considered for future trials with that Sponsor. Putting together processes like these for your site, and tracking these metrics will help you reach this goal!

Fun Bonus: Did you know you could charge for these in your budget?

budget

  • Things that can be included in your Start-Up fee (you might have more success if you break it up)
    • Contract Review
    • Supplies
    • Protocol Training/Review
    • Source Creation Fee
    • Budget Creation
    • Attendance at Investigator Meeting (travel)
    • Advertising for Recruitment
    • Putting together the Delegation of Duty Log
    • Getting your facility ready, etc.
  • IND Safety Reports
  • CTMS Management fee (could be tricky, but has worked for some!)
  • Data Administration (to pay for your EDC entry person)
  • eDiary Troubleshooting Fee
  • Pharmacy Fees: Make sure this includes pharmacy start-up, maintenance and closeout.
  • CRO Change Fee
  • Monitor No-Show/Cancellation within 48 hours
  • Annual study admin fee (again tricky, but has been done before)
  • Protocol Amendment processing fee
  • Chart review (per chart)
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Phoebe's Takeaways SCRS 2018

phoebe

Shifting Climate Towards Paperless Research Sites

Being new to the pharmaceutical clinical trials industry, I came into Site Solutions Summit only knowing the statistics of eSource adoption -- in particular, the statistic that only 13% of sites use eSource -- and as a result, thought that a large segment of the attendees would not have heard of eSource. Instead, while paper-based processes were still considered standard, there was much more awareness and buzz about "going paperless" than I expected.

However, even though many are aware of technology and agree that clinical trials should be ideally 'more efficient,' I learned that the road to adoption is a much more complex one than 'simply switching' to eSource, and as a result, many sites are wary of these idealistic claims of efficiency. How does eSource fit in with my SOPs? How do I know whether sponsors and CRAs will push back on my technology? Can I afford eSource? How do I budget it? Should I use the sponsor-enforced software, or should I buy my own? What should I look for when choosing a vendor?

I attended a few workshops which allowed me to gain insight into some of these questions:

  1. Becoming A Fully Tech-enabled Site: Why & How
  2. This workshop, led by CRIO co-founder Raymond Nomizu, brought in three site directors, from a range of site sizes.

    • Devora Torrence from Centex Studies spoke about her staff's hesitancy to switch from paper, but once they chose the right vendor & put time into training, her coordinators were highly content with eSource workflows. In particular, one coordinator who left the site to join a large hospital network using paper source ended up coming back to the site, in large part to use eSource again!
    • Seneca Harrison from Quality Clinical Research spoke about how a one person's job of entering in source data into EDC has evolved with eSource. Instead of having to track down coordinators to fill in missing information, the staff member can now finish his job in just a few hours by filling in information between computer monitors.
    • Dustin Caldwell, from Optimed Research (a large site network), spoke about the consistency and oversight that Optimed achieves by having their independently-run, geographically diverse sites all use eSource.

  3. Remote Monitoring: Site Risks and Rewards
  4. This session was comprised of a panel of sponsors, including Leesa Gentry, who edited our blog post on Ways to Start Advertising! It began with a discussion about implementing remote monitoring, but moved to an active discussion between sponsors & sites about the eSource that is sometimes pushed by sponsors versus the eSource chosen independently by sites. Many sites actively buy eSource like CRIO to streamline workflows, but the eSource that sponsors require for studies isn't often met with acceptance, because sites have to learn an entirely new workflow for each sponsor. How can we standardize eSource sometimes imposed by sponsors to the eSource that sites chooses?

  5. The Site of the Future: Technology, Processes, and People
  6. With eSource, price was the main point of discussion at this panel. Afterwards, I spoke to a site owner on the panel (who doesn't use eSource) and asked, if he knew that paper-based processes are more inefficient than eSource, what were the conditions under which he would ideally use eSource?

    "I would use eSource if it was virtually free for my site... I can't afford an extra expense, especially an expense that I'm not sure is going to result in a net benefit for my business, or better quality data."

    Fortunately, there is extensive data that supports the claims that eSource is a good financial investment and can drastically improve data quality--even reducing internal and external findings by 70%. Discussions like these are why we love talking eSource with sites that are committed to their business!

    Overall, eSource is a new technology that must continue to improve -- and the process of site implementation requires effort, from changing staff workflows, to communicating with sponsors, to ensuring that eSource is a good investment. However, sites who switch to eSource comment overwhelmingly on the long-term gains in revenue, employee satisfaction, and overall efficiency. Coming away from the conference, it seems to me that the key is to find an eSource team that is willing to support your site & staff -- so that your site can take advantage of the benefits of this up-and-coming technology.

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Anna's Takeaways SCRS 2018

Anna

Industry is Moving Towards More Diverse Clinical Trials (but we're not there yet)

One of the discussions I found most interesting was the Achievements & Direction for Site Assessments in Diversity Recruitment. This session focused on the industry-wide gaps present in recruiting patients that reflect the demographic composition of the people who might actually be using the drug after it is approved for market. Below is a slide from the session illustrating the disparity between demographics in the US population and those in US Clinical Trials. The imbalance is pretty clear.

demographics chart

Why the difference? Recruiting research study participants is notoriously and universally difficult. From actually finding eligible patients who are interested in the study, to managing the logistics of bringing them to and from the research site, many organizations who conduct clinical research are just happy to find anyone who checks off the necessary criteria. Additionally, the populations who are greatly underrepresented in clinical research also tend to be largely underrepresented in health care as a whole. Barriers range from the economic hurdles some face when trying to receive healthcare, to cultural or religious factors. No matter the reason, not having diversity in clinical trials leaves many unanswered questions about the efficacy and safety of drugs put to market.

What can be done? The panelist leading the discussion represented the efforts from both the sponsors side: Mary Elmer, Patient Innovation and Engagement Director at Merck, Diana Foster, PhD, the Vice President of Strategy and Development for SCRS, Effie Manos, the Diversity in Clinical Trials Lead for Janssen, and the research site side: Dr. Fabian Sandoval, CEO and Research Director of Emerson Clinical Research Institute.

Sponsor engagement with the issue of diversity currently seems to revolve around reaching out to minority communities with educational programs about clinical trials, something that will most likely benefit any community, as many patients are unaware of trials as a potential treatment option. Additionally, sponsors such as Eli Lilly are making concerted efforts to train, mentor, and equip minority investigators to conduct clinical research in underrepresented communities. In this way, they are attempting to overcome cultural or economic factors barring minority communities from taking part in clinical research-- people are much more likely to volunteer for a trial if their contact person is familiar with their culture.

Dr. Sandoval spoke partly to research sites and, interestingly, partly to the sponsors. To his peers, Dr. Sandoval urged sites to take notice of the cultures and backgrounds of their subjects and to be respectful and educated on social norms within those cultures-- recruiting diverse populations is one thing, keeping them for the duration of the study is quite another. To the sponsors, Dr. Sandoval asked for more support and materials for educating non-English speaking patients:

"You know there will always be at least one site that asks for study and marketing materials in Spanish, please make it ahead of time so you aren't surprised when you get that request!"

This conversation marks an important and meaningful step in the right direction for promoting dialogue between sites and sponsors, as well a shifting consciousness towards the importance of diversity in clinical research trials.

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Florida

Thank you to all who stopped by our booth and played our Mexico Sweepstakes Raffle. Congratulations to our winner, Matt K! Hope to see everyone again next year!

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