By Ann Neuer
July 13, 2012 | This year's Drug Information Association (DIA) Annual Meeting in Philadelphia was all about greater efficiencies in the clinical trials process, a key theme exemplified in its title, Collaborate to Innovate. The conference had hundreds of speakers, roundtables, and exhibitors anxious to discuss how their topic or product fit the theme, with particular emphasis on collaboration, innovation, and technology solutions that make clinical trials easier and faster.
As has become a regular occurrence, I spent much of DIA visiting exhibitors to take the pulse of e-clinical research from the vendor community. In part 1 of a 2-part series, I’ll discuss a few companies that stood out for me: Greenphire, Oracle, and a couple of standout start-ups in the Entrepreneur Pavilion. (Part II will appear in the next issue of eCliniqua.)
Faster Site Payments
A continuing problem in the clinical trials sector is that it can take months for investigative sites to see the first dime for work they have already finished (Budget Woes Stall Clinical Trials and Stymie Sites). Greenphire, a provider of a global payment platform, has designed the eClinical GPS, a web-based technology that alleviates this situation by automating payments to sites, in many cases shaving weeks or months from the payment cycle.
|Greenphire CEO Samuel Whitaker
Samuel Whitaker, co-founder and CEO, says, “At the site level, it often takes 120 days to get paid for completed work, causing real cash flow issues. Depending on how clients set up their program, the eClinicalGPS allows sites to be paid in no more than 30 days and many are paying in as little as five days.”
eClinicalGPS works by automating the tedious spreadsheet-based process that many sponsors use. “People think that the sponsor is intentionally holding back payment because it can, but the manual process at the sponsor is so painful that it literally takes that long,” he explains.
eClinicalGPS automatically generates invoices at the site level for work already completed. This information can come directly from the data feed from an EDC system or an interactive voice response system (IVRS), which informs Greenphire as to what work has been finished, site by site. The system then processes this information against the terms and budgets of the various site contracts and calculates the payments due. Cost savings from automating payments range potentially from millions of dollars for users adopting the technology on an enterprise basis, to between $70,000-200,000 for a single study.
Importantly, the site is brought into the process via portal access to see exactly what is due. “In the past, it wasn’t unusual for the site to get a check from the sponsor without knowing what it was for. We can now provide that information,” Whitaker remarks.
Greenphire also offers the ClinCard system, which allows patient payments to be delivered through electronic transfer to a debit card or directly to the patient’s bank account through an automatically generated electronic check. This solution is accessed via a centralized web-based platform, allowing clients to track and report all payments, while maintaining patient anonymity.
“Our goal is to extend the platform to enable the sponsor to manage vendor payments and eventually a portal to handle all of the financial aspects of a clinical research study,” Whitaker comments.
Improvements Across the Enterprise
In my pre-DIA discussion with Kris Joshi, global vice president, healthcare strategy at Oracle, he pointed to the need for a frictionless platform to let stakeholders seamlessly access all of the financial, clinical, operational, and genomic data across the enterprise.
|Kris Joshi, Oracle
“We need to have a common infrastructure to allow organizations to collaborate so they can speed innovation. This is critical to enable the transformation of healthcare from trial and error medicine to an information-driven world,” says Joshi.
To get there, the health sciences sector needs to cross three chasms. First is non-integrated IT -- separating applications from data. This chasm prevents people from connecting within an organization and generating insights from the data. Second is the chasm between clinical care delivery and research addressed by the move to translational medicine. Says Joshi, these two worlds must come together to make the health system a learning environment. “We can’t wait for a peer-reviewed journal article to be published before anyone does something with the insight,” Joshi says.
Third is the chasm between healthcare organizations and life sciences institutions, whereby each institution is a silo of information that is not conducive to the emerging model of collaborative R&D.
To help institutions cross these chasms, Oracle announced the release of two solutions at DIA: Oracle Health Sciences Translational Research Center and the Oracle Health Sciences Network. Translational Research Center was inspired by the observation that genetic and genomic data are rapidly becoming as much a part of healthcare delivery as routine clinical data, and are of interest to the entire community of caregivers, not just researchers.
Joshi explains, “Translational Research Center has patient-centered querying capabilities and allows researchers and clinicians to look across clinical, administrative, and massive molecular datasets to determine how many patients with specific genotypes and phenotypes might exist for a particular protocol.”
The Health Sciences Network has introduced two secure cloud-based applications. Protocol Validator connects the biopharmaceutical companies that want to validate protocol feasibility by leveraging de-identified patient information across participating health systems. The tool works with Patient Recruiter, which helps find de-identified patients among electronic health records and sends an alert back to the health system, advising of their interest in recruiting those patients.
Oracle also announced that Aurora Health Care and the UPMC in Pittsburgh have adopted these collaborative tools.
Cultivating Best and Brightest
Craig Lipset, Head of Clinical Innovation, Worldwide Research & Development at Pfizer, and this year’s DIA Program Chair, was actively involved in developing an Entrepreneur Pavilion in the Exhibit Hall. Pfizer helped to sponsor and underwrite the pavilion, which is new at this year’s meeting.
“I attended other meetings recently which had Entrepreneur Pavilions and I could feel the energy, and I wanted to capture some of that for DIA,” Lipset remarked. Participation in the Entrepreneur Pavilion was by competitive process. Social media was used to spread the word about the opportunity, and Lipset reached out to people he calls “Champions of Entrepreneurs.” These are seasoned executives who mentor young companies and have contacts at business incubators around the country.
Interested companies had to complete an application and a team from DIA reviewed them for innovation and market readiness. Of around a dozen applications, five were chosen: AxxiTRIALS, CTB Solutions, DrugDev.org, Omniscience Mobile and Patient Reminders Ltd.
DrugDev.org, a tech-driven company started in the UK, helps sponsors and contract research organizations (CROs) find qualified, experienced investigators quickly. Founded in 2008, DrugDev is a global network of investigators across many medical specialties.
|Candice Yarde, DrugDev
“Unlike companies that continue to seek investigators by faxing surveys to sites or reaching out randomly, our investigators have opted into the network as they are interested in participating in clinical research. Because we communicate with them via our network and by e-mail, they are very responsive, so we can have feasibility and site identification results back to the sponsor or CRO within 48 hours after survey launch,” says Candice Yarde, VP Business Development.
When the company first launched, the database had just 4,000 cardiologists. Now there are 67,000 experienced investigators in 93 countries. This rapid growth has been largely organic.
DrugDev works by springing into action when a study opportunity becomes available, such as a pediatric study in 15 countries. Within minutes, the company can access its database of pediatricians in the designated countries and immediately send out e-mails in multiple languages. Because so much of the success hinges on an up-to-date database, the company employs eight full-time people dedicated to this function.
To accelerate, the company offers JumpStart, which allows sponsors to engage with investigators earlier in the process. Confidentiality agreements, master services agreements, curriculum vitae and site interest forms are completed and sent online using online document management tools. This allows investigators to actively participate in the protocol development process.
According to DrugDev, the company has been able to deliver an average two-month acceleration in study start-up time, generate a 62% saving in site identification and start-up costs, and ensure that more than 95% of sites identified through DrugDev.org start patient recruitment within six weeks of activation.
Enrolling Patients Faster
Patient enrollment remains one of the industry’s more intractable challenges, so any successful efforts to streamline this activity will grab attention. One such company is Omniscience Mobile, a two-year old Virginia-based start-up, which uses a patient’s own mobile phone to speed enrollment.
|Jeff Lee, CEO Omniscence
The process starts with a patient seeing an ad for a clinical trial, and if interested he or she can respond by sending a text message of a keyword to a designated number. The system knows what study the person is interested in, and sends some pre-screening questions. “It’s a surprisingly preferred method because it’s discreet, convenient, and people feel anonymous,” says Jeff Lee, CEO.
If the prospect passes the pre-screen, the site is notified to call a toll-free number and enter a unique extension that corresponds to that prospect. Here’s where it gets interesting. It is well acknowledged that there can be breakdowns at the site in terms of their responding promptly to interested, pre-screened parties. If a site fails to call a prospect within 48 hours, that person can quickly lose interest, thereby negating all of the hard work and hefty costs associated with recruiting subjects.
“Because the callback has to go through our system, we know if the site hasn’t follow-up. If the site doesn’t call back within 48 hours, they get a reminder, and after 72 hours, there is an escalation of that call,” explains Lee.
Early this year, Omniscience launched OmniTrack, which allows site callback information to be collected in real time for any type of referral, i.e. web, call center, or text message. This enables the sponsor to see which sites are calling back and which aren’t.