Source: Novartis, IQVIA Research & Development Solutions, IQVIA Technologies

Launching clinical trials has always been a painstaking process between research sites and pharmaceutical sponsors. But for the last several years, the time between protocol approval and study activation has increased dramatically. Delayed trials may lead to unrecoverable revenues and reduced return on investment, so companies are looking for ways to combat this trend.

IQVIA Technologies explored creative solutions to this problem in Practical Approaches to Faster Study Start-Ups: Making Progress in the Face of Industry Headwinds. Contributors to the webinar included Raphaëlle Gilg of Novartis Pharmaceuticals, Kerry Randall and Rodrigo Guimarães of IQVIA Research and Development Solutions (RDS), and Rosemary Shirey of IQVIA Technologies. Together, they shared their extensive experience and gave practical guidance. This article summarizes their responses to a wide range of questions from a highly engaged audience.

Q: How can sites and sponsors partner to accelerate study start-ups?

Gilg: The pathway to acceleration is building trust in the relationship; but to do that, you must be clear on your expectations. From the sponsor side, being transparent with the site regarding when you expect milestones and explaining why they are vital creates collaboration and transparency. Suppose you are transparent, clear, and honest with your site, your company, and your collaborators. In that case, you enable the site to communicate clearly, too, for example, if they anticipate a resource issue or are launching something new, or if staff are going on holiday in the summer. You don’t want to be in the middle of the summer, and there’s nobody at the site, and your submission is stalled. It’s really about both sides being clear, transparent, and honest.

Q: How do you keep up energy and momentum throughout site activation, internally and with sites, despite the complicated deliverables involved?

Randall: Starting with the site, it comes down to building those consistent relationships and consistent communication. But just understanding the site, being able to pivot, and approaching with a spirit of collaboration and a common goal makes a difference. Consistent communication from both a sponsor and a CRO perspective is also essential. Internally, this is a challenging space, no question. You’ve heard about all the challenges that we face daily. We focus on making sure that project teams at every level, every role, are aware of their work’s broader impact and try to celebrate and recognize accomplishments and milestones across the team. And that makes a difference because what we do is essential. Activating the site’s clinical trials makes a huge, huge impact. So, it’s vital to celebrate and drive that recognition as well.

Gilg: Also, anything you can do before activation is more time to enroll patients. It’s less time for patients to wait to be treated to get the medicine they need. So that’s also about making everyone understand that if you’ve completed the training, you have access before you are activated. By the time you start, you can enroll right away, and you don’t need to have your patients wait; there’s nothing worse for me than saying, sorry, you’re not going to start the trial now because something is missing. Meanwhile, patients are waiting and at risk.

Randall: I want to add that patient focus is something we message internally to the team daily. The quicker we can get it done, the faster we can get the drug to patients, as you said. Patient care is an excellent motivator for everyone.

Guimarães: I agree. We want to focus on having time to screen patients to prepare recruitment strategies. In that case, we have to have the site journey with us to get start-up activities and readiness conducted as early as possible.

Q: Many sites are unwilling to perform specific tasks until the last minute before or during activation. How do you work with sites to move tasks up to earlier in the timeline to activate ASAP?

Gilg: Again, we need to talk to sites about why the study matters and refocus on the patients. There are serious patient needs, and their patients are waiting, so the sooner, the better. And it’s also about trying to build trust in the relationship, which is essential. Of course, you cannot force people, but it is helpful if they understand why the trial is necessary.

Randall: It’s also about thoughtful planning and driving efficiencies for sites. For example, suppose we’re contacting them about something. In that case, we should also ask them if they have any issues with access or training or anything else and demonstrate that we’re trying to help them and make the study more efficient for them. Now, the ultimate goal is to activate the site immediately after the site initiation visit (SIV). The reality is, sometimes things are outstanding, but we get as much accomplished early into the process as we can. Failing that, we do as much as possible at the SIV itself to get us across the line quickly after the SIV.

Guimarães: We’re also making technology and automation enhancements to assist sites and fill in gaps. The sites must prioritize their clients, and CROs must push for delivery. But we want to support sites to get a smoother site readiness process before the SIV. After all, we can discuss all of these elements face-to-face. So, automation and tech support are two more ways we can support sites.

Q: Raphaëlle, can you please elaborate on the value added by the Novartis Connect system to the start-up process at the site?

Gilg: The value is getting necessary documents to sites early, such as protocols, electronic case report forms, etc., because those documents guide our discussion with sites to find out what resources they need to conduct the trial. We can share them in Novartis Connect, which is built on the IQVIA Investigator Site Portal, and they can send them back via the Portal for the electronic trial master file. The Portal is also an excellent way to collaborate with and support sites and is customized for their needs. Also, once they get comfortable with the Portal, they can find the documents themselves.

Shirey: The Investigator Site Portal also allows you to build out workflows, identifying what roles at the site need to be involved. For example, I might be at a site, but I don’t need to worry about what my site is doing now. If it’s in the workflow with the specific roles that are engaged, those are the people who will get the notifications, who will need to act, and it keeps transparency for everybody.

Q: Do you have experience where a site newsletter helped to drive or motivate a site’s journey for activations?

Shirey: The studies I’ve managed all love sending out newsletters. Newsletters are popular because they help individual sites feel like part of an entire community of sites working on the trial. They emphasize that we’re working together toward the common goal of enrolling subjects to understand this drug better. Newsletters also communicate key information by highlighting relevant points throughout the study. Additionally, they motivate sites preparing for enrollment. Newsletters help sites at all stages feel like part of the team and have the information they need to succeed.

Gilg: Yes, our team also uses newsletters to create a sense of working together towards the same goal and objective and to keep sites informed on the trial’s progress and what may be missing to push the study forward. For example, we report on regional milestones when the first site is activated, etc. That information drives the energy and willingness to push further because when sites learn that others are ready to start, they are more willing to go the extra mile to activate, too.

Q: Budgets are now considerably more than the estimated initial budget proposals. How are you mitigating the increased costs for sponsors, and how much do you push back with the sites?

Randall: Ultimately, we all recognize it is about striking a balance, given the vast cost impact for sponsors. But we’ve got to get to a point quickly where we are compensating sites fairly, so it has to be data-driven from the outset. Also, sponsors need to have productive conversations with sites and say this is what we’re seeing; this is what we expect, to get that balance and focus on fair compensation.

Gilg: I agree that fairness is the key concept. On the sponsor’s side, we also want to ensure we compensate the site for their work. Another way to approach it is also, if you know you are working with a large institution, see if there are any costs that we can harmonize, like start-up costs, close-up costs, archiving, etc., so we don’t spend as much time renegotiating over and over again the same type of costs. We can focus the negotiation and discussion on the study-specific cost type. That’s another angle that drives us to speed up contract negotiations.

Guimarães: Also, if you consider the players in a budget negotiation, everyone wants to reach a decision quickly, which is easier for some studies than others. Connecting sponsors, CROs, and sites and creating a decision pathway that keeps sites out of lengthy budget negotiations in case things will not proceed is common sense. Taking the budget off the critical path is vital to the process as a whole.

Q: We’ve seen an increase in sites dropping out shortly after activation. Is this something you are also seeing, and, as a follow-up, what is your take on this?

Guimarães: In the data I have seen, that is part of the environment that we’re living in, and it ties to site capacity challenges. Sites are more burdened and must decide whether it’s better to stay in or leave studies.

Our ability to build a relationship with sites from that initial outreach enables us to resolve obstacles earlier, even protocol-related issues, establish eligibility criteria, and guide sites through the start-up period. Sometimes, we reach a point where the site realizes there may be an additional burden that they hadn’t realized. Having a site engagement process during the activation period is key.

Q: Is IQVIA’s Investigator Site Portal different than the DrugDev Portal?

Shirey: They are the same product. IQVIA acquired DrugDev Inc. 5-6 years ago and renamed the DrugDev Portal the IQVIA Investigator Site Portal. IQVIA RDS brought it into their CRO operations and is one of our largest users of the Portal, alongside Novartis and many other sponsors. We’ve been continually improving and building additional resources into the product, especially in the area of site activation. Novartis has been with us through this journey and uses the Portal on every study they run, and I know they get a lot of positive feedback from sites for providing that consistent experience across trials.

About The Authors

Raphaëlle Gilg is the Strategy and Operations Manager for Novartis Pharmaceuticals. Raphaelle started her career as a nurse in cardio intensive care units. With a passion for novel ways of treating patients, she naturally switched gears to clinical research, first becoming a Clinical Research Associate and then moving into different roles across the industry. Raphaelle now leads Novartis Site Engagement from the Business Operations side, striving to establish positive and efficient site-sponsor relationships, continually addressing study start-up and site initiation timelines, and finding solutions that best empower study teams to access key study documents and information in an easy way, removing administrative burden.

Kerry Randall is the Vice President, Global Head of Site Activation for IQVIA R&D Solutions. Kerry leads a worldwide team focused on getting sites to a point where they are able to enroll patients into clinical trials. She joined IQVIA in Singapore as Head of the APAC Global Business Operations team in 2011, then returned to the UK in 2016 to lead a similar EMEA team. Her passion for process improvement and organizational development led her to roles in study start-up and site activation. Kerry holds a BSc in Economics from University College, London, and an Executive MBA from INSEAD (Singapore).

Rodrigo Guimarães is the Vice President, Global Site Activation for IQVIA R&D Solutions. Rodrigo has more than 20 years’ experience in clinical development with pharmaceutical and contract research organizations. He joined IQVIA in 2006 and has served in leadership positions at both the regional and global level in site start-up, investigator contracts, clinical operations, and real-world evidence operations. He has also served as President for ABRACRO (a Brazilian CRO association). Rodrigo currently heads Country Site Activation teams, overseeing a 1,300-employee workforce responsible for delivering site ID, regulatory submissions, and investigator contracts, ensuring clinical sites are ready to enroll. He earned degrees in Pharmacy and Biochemistry from the University of São Paulo, a specialization in business administration from the Sydney Business Academy, and an MBA from Fundação Getulio Vargas.