By Allison Proffitt

January 27, 2017 | It was a packed week at the 8^th annual Summit for Clinical Ops Executives—SCOPE—in Miami. In addition to the conference content, expo hall buzz, and awards, several companies took advantage of the SCOPE audience to make new product and business announcements. Here are a few of the exciting things I heard and saw on the show floor.

Patient Recruitment Through Ride Hailing

My first meeting of the event was with Lyft and Continuum Clinical. The two announced a partnership through which patients enrolled in clinical trials will be able to use the Lyft app or Lyft’s Concierge program to secure transportation to and from the trial site, free of charge. The program will help to ensure that patients enrolled in the trials won’t miss appointments, which may potentially disqualify them from the trial. Continuum plans on trialing the Lyft program this quarter for a national study on lupus, Nariman Nasser, Continuum’s VP of Site Optimization, told Clinical Informatics News. This isn’t Lyft’s first foray into clinical trials transport. In 2016, Lyft partnered with a number of senior care providers and healthcare systems for non-emergency transportation services, and explored clinical trial transport as well. But the partnership is the first to use Lyft transportation as part of the recruitment process.

Continuum doesn't expect to differentiate between patients at all, but to offer the Lyft rides to all trial participants. Rides can be offered in two ways, explained Dan Trigub, Lyft’s Strategic Account Executive for healthcare. Patients can be given Lyft codes to apply to trial transportation or Lyft’s Concierge program and arrange rides for trial participants through the call center Continuum already engages. The codes a feature-rich, Trigub explained. They can time and date restrictions, value restrictions, and even geofencing—geographical limits on where they can applied.

Concierge is a full service option, arranging rides for patients who may not have a smart phone or want to learn the Lyft app process. It’s just anecdotal evidence so far, Nasser emphasized, but Continuum is finding about 60% of trial participants use the Concierge service through the call center.

Continuum is working to quantify that anecdotal evidence. For rides booked both through the app and through the call center, Continuum will track how much time patients spend in transit; how much money the sites save in parking, mileage, and tolls; and how Lyft transportation impacts recruitment, retention, and missed appointments.

Our goal, really, is to reduce the work burden for sites and improve patient satisfaction, Nasser said.

CRO Oversight Solution Addresses Looming ICH E6 Addendum

With the upcoming ICH E6 (R2) addendum, clinical teams face the difficult process of reducing risk while ensuring quality across studies outsourced to Contract Research Organizations (CROs). At SCOPE this week, Comprehend Systems announced new CRO oversight features as part of its Clinical Intelligence Suite. The CRO dashboard monitors CRO Quality Agreements and Oversight Plans in real-time, explained Kevin Kennedy, Comprehend’s Chief Revenue Officer.

It’s a functionality that’s been in the works at Comprehend for a while, and Kennedy said it was top of mind at SCOPE. It’s a solution just to deal with R2, Kennedy explained. The CRO dashboard lets study sponsors and CROs work together to identify risks and decide what to measure and monitor. Sponsors can set milestones or thresholds that trigger joint review to identify potential problems quickly. It’s a foundational concept that underlies all of the Clinical Intelligence Suite, Kennedy said. Comprehend aggregates clinical data from sponsors and CROs and “turns on” applications tied to key performance indicators. The more data that goes into the platform, the richer the data analysis can be. The Clinical Intelligence Suite so far comprises the ClinOps Insights application, which includes the CRO dashboard; centralized monitoring which supports risk-based monitoring initiatives; and medical monitoring.

Patient Engagement & Physician Equipping at the Point of Care

During one of the keynote panels at SCOPE, a speaker lamented the lack of visual and immediate engagement with potential trials participants. What someone needs to invent, she said, is a big screen in the doctor’s office that can illustrate what’s going on for the patient and what the options are. On Tuesday, Outcome Health (newly rechristened from Context:Media) unveiled that very solution. 

The Outcome Health technology platform includes a suite of waiting room and exam room digital tablets, wallboards, and monitors for use at both principal investigator and specialty physician sites. But these aren’t just digital advertisements. Don Butler, ContextMedia’s senior vice president of research & development solutions for life sciences, showed me the exam room wallboard. The custom-made board lets doctors and patients interact with their disease and directly connects patients with trials. The wallboard looks like a giant touch screen phone. It’s loaded with digital anatomic models— Outcome Health is partnering with The Center for Information and Study on Clinical Research Participation (CISCRP) to produce educational content—that let doctors illustrate, manipulate, and draw on organs and tumors in real time with the patient. All the notes and images can be emailed to the patient with a few taps.

It’s beautifully compelling, but the patient engagement doesn’t stop there. Physicians can use the same device to introduce patients to appropriate trials, explaining how a trial is a fit for their disease. Digital tablets then give the patients more information, letting them explore details about the trial and express their interest. Butler said the devices are now in 55,000 practices and 1,500 are coming online each month.

Unified Offering From DrugDev

After a season of fast and furious acquisitions, DrugDev unveiled Spark at SCOPE this week, a comprehensive, unified clinical operations suite to manage every part of clinical trials. DrugDev Spark marks the retirement of the brand names of TrialNetworks, CFS, and SecureConsent. DrugDev Spark brings all of the functionalities into a cohesive product and interface, Brett Kleger, DrugDev’s CCO, told me while we sat outside, enjoying the Miami sunshine. Different functionalities are modules within DrugDev Spark, and can still be a la carte, or as an end-to-end platform. DrugDev’s Golden Number for investigators and sites, for which the company won a Best Practices award, runs throughout every module.

While Kleger shied away from any absolutes—“we’re always exploring options”—he did indicate that the acquisitions of the past few years may slow down, now, for DrugDev. We have the bulk of the modules we need, he said. We really have an end-to-end solution for clinical operations.

DrugDev Spark represents a shift in the business culture and approach as well. After integrating so many teams over the past years, DrugDev is now an integrated company and culture, he said. And the business approach has followed suit. “For years we’ve been selling study by study, trial by trial,” he said. “Last year we entered the enterprise arena. Clients look at the solution differently now.”

Patient-Centered Staffing

CROS NT has launched its new Functional Service Provision (FSP) model, staffing designed to meet the needs of pharmaceutical, biotechnology, and medical device companies. FSPs provide dedicated resources right at the site, explained Peder Henrik Seglund, CROS NT’s senior VP commercial for North America. Usually at least one staffer is based on site, speaking the local language, and liaising with remote workers, Seglund said. Within this model, CROS NT also offers a Micro FSP approach for teams of less than 10 people. It is particularly suitable for small- and medium-sized companies and reduces the risk of not having enough work, or too much work, for full-time employees. The model is scalable, Seglund explained. CROS NT can staff 100 programmers or 10, full time or part time, and can be flexible within the duration of the job, paring down resources after launch if needed.

The company also announced its acquisition of the clinical division of PM Clinical Limited, a sister company under the PM Holding entity currently based in the United Kingdom and Italy. The move expands CROS NT’s service offerings by adding regulatory consultancy, study design, feasibility, clinical project management and monitoring. The acquisition shifts CROS NT from a biometrics-focused CRO to a more patient-centric and data-driven niche provider.

Now as a full service CRO, CROS NT can offer risk-based monitoring, feasibility studies, and data analytics, Seglund said, with a major focus of work on oncology, CNS, and respiratory indications.

Into the Fold

Greenphire has partnered with Exostar bringing web-based Single Sign-On (SSO) functionality to Greenphire’s eClinicalGPS global clinical site payment platform. Exostar’s identity and access management platform serves as the gateway to TransCelerate’s Shared Investigator Portal (SIP), verifying user credentials before granting SSO access to connected sponsor and third-party applications. By teaming with Exostar, Greenphire’s eClinicalGPS is now directly available with valid credentials throughout the TransCelerate SIP and Exostar life sciences communities.

“There is a great deal of administrative burden placed on a research site to support a clinical trial. Greenphire’s solutions are designed to reduce this burden and allow investigators and research staff to focus on supporting the trial, not tracking payments,” said Jim Murphy, CEO of Greenphire. “This collaboration with Exostar brings simplicity to the user experience, making it even easier to take advantage of our powerful payment solution.”

New Trial Management Software

ArisGlobal has announced agClinical 3.3, the latest version of its comprehensive clinical trial management software. This release further enables life science organizations to confidently and efficiently meet new compliance and submission requirements, improve risk-based monitoring and better manage the electronic trial master file so that compliance is assured and transparency is improved. agClinical 3.3 includes global trial submissions regardless of region, country or regulations; enhanced automation for the monitoring process to increase the efficiency of Clinical Research Associates (CRAs); and a risk assessment categorization tool as defined by TransCelerate along with improved document management and third party integration.