驯服复杂的临床试验生态系统-一种已经产生影响的新方法（英）

A new approach that’s already making an impact. IQVIA TECHNOLOGIES As the clinical trial ecosystem expands to include awide range of new and innovative technology solutions,clinical trial sites that, ideally, stand to benefit from theseofferings, are becoming increasingly vocal about thecorresponding administrative complexity. With everynew system, a site team must navigate additional logins,portals, and interfaces. To tame this complex clinical-trialecosystem, IQVIA Technologies developed One Homefor Sites™ (One Home), a vendor- and sponsor-agnosticsolution to tech overload that enables single sign-on(SSO) and study organization across clinical systems. In awidely attended webinar, IQVIA’s Lesley Freese,Senior Product Manager for One Home; Rob Osterhaus,Director of Partner Ecosystem; and Julie Lightfoot, SeniorDirector of Alliance Management, spoke with BrianHunter, VP at CNS Healthcare, and Kasey Bumber, SeniorDirector of Product Management at Signant Health, toshare perspectives on the progress and promise of OneHome. Together, these clinical stakeholders consideredhow One Home can help chart a mutually beneficialpath toward streamlined clinical trial management forsponsors, sites, and technology providers. As a leader in the industry, IQVIA recognized the needfor a solution to tech overload and sought to design asystem that provided a single point of entry for its ownarray of technology platforms and portals. Per Freese,“When I started interviewing site staff on how best toapproach this, many very kindly said, I’m glad to seeyou’re doing this, but at the end of day, it doesn’t solvemy problem because I have lots of additional systemsfrom other technology vendors that I need to access.” The multiplication effect CNS Healthcare’s network of experienced sites isno stranger to the increasing technological load onthe clinical landscape. According to Hunter, “It’s notuncommon for there to be 12 to 15 vendors per studyfor our sites. When you multiply that by the number ofstudies going on simultaneously at each of our sites,that is a huge number of portals that we’re logginginto regularly to complete our required tasks.” Figure 1represents this multiplication effect. Though the industry is striving for better collaboration,sites are still navigating work across multiple sponsors,CROs, and vendors. Site coordinators now serve asintermediaries between trial participants and technologyproviders, frequently stepping in to help patientsnavigate their own set of patient portals and apps.Burnout and turnover often result. “It’s not uncommon for there to be 12to 15 vendors per study for our sites.” — Brian Hunter, CNS Healthcare “In other words, when site users havemore than one single sign-on, theydon’t have single sign-on at all.” In other words, when site users have more than onesingle sign-on, they don’t have single sign-on at all. — Lesley Freese, IQVIA Technologies With this fundamental user feedback and a holisticlook at the clinical trial ecosystem, IQVIA Technologiesrecognized that a collaborative, industry-wide approachwas the only viable solution (Figure 2). From there, thevision of One Home for Sites was born. Understanding One Home for sitesWHAT ONE HOME IS NOT •An internal IQVIA system: One Home is not just forIQVIA’s CRO or sites running IQVIA studies. The One Home solution •Another portal for sites to access: One Home does notseek to replace or compete with other clinical systems. With IQVIA being the largest contract researchorganization (CRO) in the world, several preconceptionsof One Home emerged. Freese addressed these bydefining what One Home is and what it is not (Figure 3). •Another data entry point: One Home does not handledata workflows between or within systems. WHAT ONE HOME IS •Independent of the CRO model: One Home is free tosites and tech vendors and available for sponsors andCROs to license for all of their studies, regardless ofstudy structure. •An industry-wide platform: One Home provides SSOand affiliation so that sites can reach all of their clinicalsystems faster. •A flexible dashboard for access and action: One Homeallows the user to tailor their experience to suit theneeds of their role. “It was a no brainer for my team. Weassessed this as quite a light lift tobegin drastically improving our enduser experience.” One Home aims to provide an organized, streamlinedspace for sites to move from system to system acrossstudies and sponsors, enabling them to complete theirwork more efficiently (Figure 4). — Kasey Bumber, Signant Health approached Bumber’s team at Signant Health aboutjoining One Home as a technology vendor, the choicewas simple: “It was a no brainer for my team. Weassessed this as quite a light lift to begin drasticallyimproving our end user experience.” Signant Healthwas the fourth vendor to be onboarded. The licensed version of One Home, purchasedby a sponsor or CRO, enables automatedstudy and system setup for sites. As a siteuser logs into One