june 2016 fiercemarkets custom publishing, in partnership...

Exploring Digital Health Technologies: The Devices and Data Being Used in Trials Today

FierceMarkets Custom Publishing, In Partnership with:June 2016

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n5 Sponsored Content: Digital Health in Remote Patient Monitoring: Enabling Greater Visibility and Patient-Centricity

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n12 Integrating Digital Health Data: Getting Started

n13 About Validic

Exploring Digital Health Technologies: The Devices and Data Being Used in Trials Today // June 2016

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Do you Know Your Medical Device Terminology?

The medical device sector, and by extension, the digital health market, is governed by regulations that take a risk-based approach to dictating the level of scrutiny each particular product faces. Here, we define common terms sponsors may encounter when assessing digital health devices.

Consumer-grade: Devices in this category are generally considered Class I devices and are not FDA-cleared devices. Consumer-grade devices tend to be appealing in style, functionality and price point to consumers and many have a consumer-facing app paired with the device. Data collected from these devices can typically be used as exploratory endpoints in clinical trials.

Class I: These devices are generally defined as “low-risk” as they are not designed to treat potentially fatal conditions and likely will not cause life-threatening harm if misused. Devices in this class do not have to be approved by the FDA and are generally available over the counter.

Clinical-grade: Clinical-grade devices deliver data that are validated and can be used as a primary or secondary endpoint in regulatory filings. While some clinical-grade devices offer consumer-friendly designs and paired app, not all clinical-grade devices provide these benefits, and they can be more costly.

Class II: Most clinical-grade devices are considered Class II devices. The exceptions are those that sustain or support life, are implanted or present potential unreasonable risk of illness or injury (Class III devices), and those that present minimal potential for harm to the user (Class I devices).

510(k): A premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective or substantially equivalent, that is, to a legally marketed device that is not subject to premarket approval.

FDA-cleared: Medical devices in this category have been determined by the FDA to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA and approved for clearance.

Class III: Class III devices typically pose the highest risk and are therefore subject to the highest level of regulatory control. The FDA must approve these devices before they are marketed.

Premarket approval: This approval process is generally reserved for high-risk Class III medical devices and involves a more rigorous premarket scientific and regulatory review to evaluate the safety and effectiveness than the 510(k) pathway.

FDA-approved: The FDA has approved a premarket approval (PMA) application prior to marketing the device. This approval process is more intense than the 510(k) pathway and is generally reserved for high-risk medical devices.







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Exploring Digital Health Technologies: The Devices and Data Being Used in Trials Today

Today, digital health technologies are improving clinical trial processes, streamlining timelines and enabling remote monitoring of participants. The market for these technologies is rapidly expanding and is expected to reach $59 billion by 2020. But with continuing technological advances resulting in more and more devices, it can be difficult to stay up to date on what technology is available and what is applicable to clinical trials.

In this eBook, we’ll explore the four categories of digital health technologies — wearable fitness devices, clinical devices, sensors and applications — and show how the data they gather can help clinical trial sponsors.

WearablesWearables are defined as electronic devices that are small or light enough to be worn or carried on one’s body. These products use multi-axis accelerometers to measure the movement of the device. Readoutsare then turned into data reflecting the frequency, duration and intensity of the wearer’s activities. This is how wearables

generate what many consumers consider the most important data point: a count of steps taken.

Tracking of step counts on wrist-worn devices remains a primary use case for wearables, but it is just one example of what the technology can achieve. Many wearable devices are now incorporating accelerometer readouts into analyses of sleep patterns. The accuracy of the sleep analyses is aided by data from other sensors, notably the heart rate monitors now built into devices. This mix of sensors is facilitating analyses of different stages of sleep, such as rapid eye movement, while the heart rate data can also be viewed in isolation to give a continual overview of cardiac activity. In the near future, wearables will also be able to monitor blood pressure and skin conductance.

The most famous examples of wearables are consumer-grade, wrist-worn activity trackers, such as those sold by Fitbit, Jawbone, Garmin and other manufacturers. Consumer-grade wearables are typically less expensive than clinical-grade devices, plus they have sleeker and







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more consumer-friendly designs and are paired with consumer-facing apps that provide read-outs of the data collected. These benefits allow consumer-grade devices to fit more seamlessly into clinical trial participants’ lives, thus increasing the likelihood of their ongoing use.

From a clinical trial perspective, the data from Class I consumer devices are helpful, but researchers need to be aware of how the data can be used and the limitations. “While the data from consumer devices aren’t typically used as a primary or secondary endpoints in a trial, as it is not considered clinically-validated, the data can still be useful information for researchers when used as exploratory endpoints,” said John Reites, head of digital health acceleration at Quintiles. In such exploratory situations, the low cost and ease of use of consumer devices make them a popular choice for clinical trial sponsors.

Specialized, clinical-grade wearables known as actigraphs can be used to gather data for a primary or secondary endpoint. These products, which are typically wrist-worn Class II devices, resemble consumer-grade activity trackers but have been through the FDA 510(k) pathway and yield validated data that are seen by regulators as reliable enough to support safety or efficacy claims. The types of data clinical-grade devices generate are comparable to the metrics tracked by consumer wearables. Some actigraphs also expose more detailed granular data, such as the raw accelerometer movements. As such, sponsors can use wrist-worn clinical-grade devices to monitor activity levels, heart rate and sleep patterns. The benefit of clinical-grade wearables is that they are FDA-cleared devices, but they are more costly

and lack some consumer-friendly benefits like style and a paired app.

Both consumer- and clinical-grade devices track metrics continually, enabling sponsors to assess the status of clinical trial participants between site visits—an impossible task before. “Most of the measures [wearables track] are relatively novel,” said Zubin Eapen, M.D., M.H.S., assistant professor of medicine at Duke University Medical Center and investigator at the Duke Clinical Research Institute. “We haven’t measured them with this frequency or continuity and in the outpatient space.”

The transition from episodic to continual data collection has significant implications for the design of clinical trials. Sponsors have traditionally taken snapshots of trial participants’ functional status, for example, by having them perform the six-minute walk test when they visit a study center. Wearables, in contrast, allow sponsors to gather walking data all the time. As an example, Eapen said, “We can essentially transform the office-based, six-minute walk test into an accessible measure for the 21st century.” In doing so, sponsors can reduce the need for participants to visit trial sites. This lowers sponsor costs and the burden of participating in a study.

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The low cost and ease of use of consumer devices make them a popular choice for clinical trial sponsors.







Sponsored Content

Throughout the duration of a study, researchers must frequently monitor clinical trial participants’ reactions to a drug and capture precise sets of measurements. These measurements have traditionally been gathered at frequent office visits or through constant at-home manual tracking by the participants. Utilizing digital health devices in remote patient monitoring can streamline the process, however, and enable the seamless collection of key biometric and activity data. Those patient insights can then be quickly transmitted directly to clinicians. This approach reduces the need for costly and time-consuming in-person evaluations and enables shorter clinical trial duration, benefitting researchers and trial participants alike.

Greater visibility for researchersBy arming participants with wearable and FDA Class II medical devices, sensors and mobile applications, researchers gain greater visibility, providing the following benefits:

• Holistic and objective view of a participant’s response to a drug. Researchers can gain a more holistic picture of a participant’s response to a drug by continuously collecting data from digital health devices between office visits. Additionally, the data collected via digital health devices is

more objective than relying on a participant’s subjective recall, which can be skewed based on how he or she is feeling that day.

• Earlier decision-making. Access to real-time data provides researchers the ability to make amendments to protocols and go or no-go decisions based on how participants are reacting to a drug. Early signals can also be detected to help identify whether the drug is more effective for specific subsets of the study population, as well as understand the impact of participant behaviors.

• More accurate intervention triggers. Data from digital health devices can alert researchers to potential adverse events sooner. Conversely, a lack of data transmitted from the devices is also informative—such as alerting researchers to potential non-adherence, thus providing them with better operational insight. For example, a null report from a connected glucose meter can trigger a reminder for the participant to take a reading or communication from the investigator to assess for other issues.

Patient-centric protocols enhance participant enrollment and engagementRemote patient monitoring also enables pharmaceutical companies to design trial protocols

that are patient-centric, reducing the burden on participants and enhancing engagement in a number of ways:

• Fewer office visits. Cumbersome trial requirements can deter patients from enrolling in a trial. By collecting data remotely, sponsors can design trials with fewer office visits, which can increase the likelihood that patients will or can enroll in a trial.

• Reduced recall burden. Trial sponsors are frequently concerned about the validity of patient recall. With remote monitoring, the continuous and real-time stream of data can provide feedback in a more consistent and comprehensive manner—thus reducing the burden on patients to recall information in a detailed manner.

• Less manual entry. Since data is automatically integrated from digital health devices, participants don’t need to track or record it manually. This reduces the potential for errors, as well as the time and effort required to record it.

As the pharmaceutical industry continues to embrace digital health offerings and the impact they can have on the drug development process, we’ll see all involved stakeholders benefit, and ultimately, the more efficient creation of drugs that can significantly impact patient lives.

Digital Health in Remote Patient Monitoring: Enabling Greater Visibility and Patient-Centricity


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Sponsors are using wearables to realize these benefits today. According to the National Institutes of Health’s records, at least 299 clinical trials were using wearables as of late 2015. Examples include:

• Biogen uses a wearable device to track the physical activity of multiple sclerosis patients.

• Cedars-Sinai adopts a wearable device in an oncology trial to help determine if patients are active enough for chemotherapy.

• Bayer deploys a wearable device to evaluate the correlation between activity levels in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

As the pharmaceutical industry becomes more

comfortable with the devices and the capabilities of the wearables themselves broaden, the number of clinical trials utilizing digital health technologies is expected to expand.

Clinical Devices Clinical devices are instruments, implements or machines intended for use in the diagnosis of disease or monitoring of conditions. Common examples include blood pressure cuffs, glucose meters, sleep devices, spirometers and weight scales. Such devices have been central to the collection of data in clinical trials for decades. For example, they enable sponsors to assess the ability of hypertension drugs to lower blood pressure, or to evaluate the effect of a treatment for diabetes mellitus on fasting plasma glucose levels.

These data and the clinical devices that generate them are widely accepted by regulators, typically as surrogate endpoints for long-term complications related to the target condition. Sponsors can use clinical devices to measure the effect of a drug on blood pressure, giving regulators a way to assess the likely impact on the long-term endpoint of cardiovascular mortality without forcing the applicant to run a multi-year trial. Regulators expect the clinical devices that generate these data to meet certain standards. In FDA terms, most are Class II devices that follow the 510(k) pathway.

In recent years, innovators have begun to combine these well-established clinical devices with digital health technologies. The result is a collection of devices that retain the ability to gather regulatory-grade data but also boast features more commonly associated with







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wearables. These features are altering how clinical devices are used in clinical trials. As clinical devices have become smaller, more user-friendly and capable of wireless communication — developments enabled by advances in mobile technology — the range of data sponsors can collect remotely has expanded.

For example, blood pressure monitoring technology began as on-site equipment for physicians. Over time, models designed for home use emerged, but patients had to either manually record the readouts or take the device to a site for the data to be downloaded. Both of these methods raise the risk that the data will be incomplete, inaccurate or even lost entirely. Connected blood pressure cuffs are mitigating this risk. With such devices, data can pass wirelessly and instantaneously from a cuff to a smartphone and into the clinical trial’s platform or system.

Similar workflows are being enabled by the addition of digital health capabilities to other types of devices, resulting in sponsors gaining the ability to remotely, and in some cases continually, monitor changes in participants’ weights, blood glucose levels, lung

functions and other clinically-relevant endpoints. The breadth of types of data that can be collected — and the frequency with which this can happen — will expand over time. “One of the values I see in digital health is it could enable more depth in the data we collect [in remote trials],” Quintiles’ Reites said.

Examples of clinical trials using connected clinical devices include:

• The University of Pennsylvania uses home blood pressure monitoring in hypertensive patients with a history of cerebral infarction.

• Johnson & Johnson employs connected blood glucose meters along with companion apps to drive a reduction in A1C levels in patients with diabetes.

• The University of Leeds and Philips Healthcare use connected thermometers and in-home blood count devices to monitor chemotherapy patients.

According to a Soreon Research report, the smart wearable healthcare market will grow from $2 billion in 2014 to $41 billion in 2020, with diabetes, sleep disorders, obesity and cardiovascular disease representing the segments with the largest growth.

While this vision of the future of clinical trials is emerging quickly, the vast majority of clinical devices are not currently Bluetooth-enabled. New technology leveraging optical character recognition (OCR), such as Validic’s VitalSnap™, can help overcome this challenge. It enables users to capture health data from non-connected medical devices via their smartphone’s

“One of the values I see in the digital health market advancing, is it could enable more depth in the data we collect [in remote trials].” JOHN REITES, HEAD OF DIGITAL HEALTH ACCELERATION AT QUINTILES






validic.com @validic

Connecting todigital health deviceshas never been so easy.

Digital health – the use of in-home clinical devices, wearables, sensors and applications to remotely collect valuable patient data – is impacting the pharma industry and revolutionizing clinical trial processes and medication adherence.

As the industry’s leading digital health platform, Validic is helping companies like Medidata, Quintiles and Amgen easily integrate the actionable, patient-generated data from digital health devices and apps.

Are you ready to get up to speed on digital health and explore the impact it can haveon your trials and initiatives? To learn more, contact us at [email protected].

Working with Validic is a big step toward

realizing the potential of mobile health in

clinical research because it o�ers life

sciences organizations the flexibility to select

the mHealth tools that provide the most

clinically meaningful information for specific

patient populations. We’re excited to be

working alongside a like-minded company

that is using technology to transform the way

stakeholders across the healthcare industry

collaborate and innovate.

– Glen de Vries, President, Medidata

https://validic.com

http://twitter.com/validic


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camera, and the data are automatically transferred to the clinician. This technology gives researchers the ability to integrate digital health data from the non-connected devices that are already clinically validated and being used in the trial.

“With VitalSnap, we are going to be able to engage patients in a way that has not been possible before,” said Drew Schiller, co-founder and chief technology officer at Validic.

SensorsSSensors are devices that detect or measure physical properties and record or respond to this input. For example, sensors power wearables by measuring movement and other physical characteristics. Expanding further into digital health, sensors are now being incorporated into existing and new devices to measure an array of physical properties that were previously difficult or impossible to track. Current examples of products that make use of sensors include medication bottles capable of recording when they are opened, tablets that log when they are swallowed and body-worn patches that deliver a stream of data about the movement, heart rate and caloric burn of an individual.

These technologies are all available for use by clinical trial sponsors today, but the smart medication bottles are the most established form of sensor-enabled devices. When these bottles are opened, they communicate the event wirelessly, either via a built-in cellular signal or a Bluetooth connection to a smartphone. Both forms of communication achieve the same goal of providing the clinical trial sponsor with data to show adherence to the

treatment regimen. Study organizers can also remind a participant to take their medication by sending a signal that causes the pill bottle to light up or beep.

“One of the challenges in clinical trials is you are never 100% positive that someone took their medication as instructed,” Schiller said. “Typically, people really try to do it ... but there are missed dosages, and often those missed dosages go undetected.”

A growing number of pharma companies are exploring sensor-enabled devices, including pill bottles, inhalers and syringes, to address this challenge. The data these devices generate are useful on a number of levels. “Sensors can be used with the intention to better measure compliance to medication, not only whether they took it, but also the timing of when they took it,” said Ferry Tamtoro, director of software development, digital accelerator labs at Amgen.

With some clinical protocols mandating that the drug is taken — for example, every six hours — having detailed data on medication times can help to demonstrate

“Sensors can be used with the intention to better measure compliance of medication, not only whether they took it or not, but also the timing of when they took it.” FERRY TAMTORO, DIRECTOR OF SOFTWARE DEVELOPMENT, DIGITAL ACCELERATOR LABS AT AMGEN.







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compliance and explain outliers in the safety and efficacy results. Traditionally, it has been impossible for sponsors to tell whether a variation in the data is an effect of the medication or simply a consequence of participants failing to comply with the protocol. This is a problem for all clinical trials, but for some studies, in which the time the medication is taken is critical, the issue is particularly acute.

Previously, on-site administration by a clinician was the only way for a sponsor to be confident that participants were complying with such specific, time-sensitive details of a protocol. “That is not very convenient for participants and obviously it’s more costly for sponsors as well,” Tamtoro said. Sensors have enabled the shift from on-site to remote administration in more trials. “Having the sensor tells researchers whether things are getting done properly, so it reduces the cost, it helps with enrollment—because it’s more convenient for the participants—and it streamlines the clinical trial,” Tamtoro said.

Other companies are using sensors in different ways to achieve similar goals. For example, sponsors can now incorporate sensors into pill tablets. When the sensor-enabled tablet is swallowed and reaches the stomach, it sends a message wirelessly to a patch worn on the body of the trial participant. The patch logs the time at which it received the message from the tablet and passes this information onto the clinical trial database. This gives the sponsor a detailed record of exactly when each subject took medication.

In this workflow, the patch is just relaying information. However, by adding sensors to such patches, other companies are using similar devices to gather data directly. These sensor-enabled patches can collect high-quality data on the movement, heart rate and caloric burn of an individual, making them a useful alternative to wrist-worn wearables in some clinical trials.

Examples of clinical trials that have incorporated sensors include:

• UCB utilizes a wearable sensor to track Parkinson’s symptoms, monitoring physiological parameters, such as limb movement.

• GSK adds sensors to inhalers to collect and record data on patients’ usage automatically.

• Otsuka embeds Proteus Health’s ingestible sensor into a drug for schizophrenia and bipolar and major depressive disorders. The sensor works in tandem with a patch worn on the skin so physicians can tailor medicines more closely to reflect medication-taking patterns and lifestyle choices.

“Having the sensor tells researchers whether things are getting done properly, so it reduces the cost, it helps with enrollment—because it’s more convenient for the participants—and it streamlines the clinical trial,” FERRY TAMTORO, DIRECTOR OF SOFTWARE DEVELOPMENT, DIGITAL ACCELERATOR LABS AT AMGEN







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ApplicationsMobile applications are software programs designed to run on devices such as smartphones and tablets. Apple, Google and Microsoft all run app stores where individuals can buy and download apps for devices that run on their respective mobile operating systems. Each store features many apps focused on health, which has become a major piece of the marketplace in the short history of the mobile economy. Patients are using apps to turn their smartphones into devices that can help better manage their health by tracking a myriad of factors including diabetes-related symptoms, heart rate, sleep, fertility, physical activity and weight.

Pharmaceutical companies are among the developers of apps, some of which are designed for use in clinical trials. Companion apps, which are designed to be paired with a medication, are a common form of mobile clinical research software program. “We’re developing and using mHealth companion apps and approaches now in the market, which is becoming a more consistent strategy in our industry,” Quintiles’ Reites said. Sponsors are using these apps to communicate with participants, for example, by sending a reminder notification of an upcoming site visit or by providing information designed to drive engagement in the study. These messages appear as alerts on the user’s smartphone or tablet.

The close relationship many people have with their smartphone or tablet makes the devices an ideal way of communicating with clinical trial participants. Few people go for long periods of time without checking their phone, so sponsors can be more confident participants will see their messages. This also makes mobile apps well

suited to the collection of patient-reported outcomes (PROs). A companion app can alert a participant to the need to complete a short survey. Also, because people are familiar with how to use their own mobile devices, they are likely to be able to complete the survey quickly and more accurately.

Companion apps are one of two notable ways in which clinical trial sponsors are using mobile technology. The other is the use of mobile apps to help recruit trial participants and to monitor them remotely. In this model, which was pioneered by Apple’s ResearchKit framework, the app becomes the primary interface between a participant and a study. Instead of enrolling at a clinical trial site and visiting it periodically to interact with the study team, participants go through the whole process remotely via an app on a smartphone or tablet. Participants sign up for the study and contribute data without ever meeting the trial organizers in person.







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The first wave of ResearchKit-enabled studies were run by academic teams, but the potential for the app-led approach to quickly and inexpensively recruit large numbers of participants has attracted the interest of the industry. “There are now a number of mostly late phase or observational research studies where we use mobile health integrated with a digital front end or wearables ... with one central primary investigator,” Reites said. “It can be fast, it can be effective, it can get your data very quickly, it can be a very simple experience for a patient.”

Use of a fully app-led approach is limited to certain types of trials, because the data generated lack the rigor to support regulatory filings. A ResearchKit-run study, for example, has inherent population bias because it is limited to people who own iPhones, which data suggest are more likely to be college graduates than users of Google’s Android operating system. For now, this is limiting the type of trials that are suitable for the app-led, fully virtual approach, but it is not preventing sponsors from incorporating aspects of the technology into more traditional studies.

More and more sponsors are using ResearchKit to supplement its traditional clinical trial enrollment activities. In this model, ResearchKit-enabled enrollment is performed in parallel to traditional forms of recruitment in an attempt to accelerate the process. “ResearchKit allows you to reach a much broader population,” Tamtoro said. “Instead of just being limited to the reach of different clinical sites, ResearchKit apps enable reach to a bigger population and then funnel participants that have been prescreened to the clinical sites for a deeper evaluation.”

Examples of applications being used in trials include:

• AstraZeneca incorporates a mobile app that gathers information about side effects into three clinical trials studying an experimental combination therapy for ovarian cancer.

• Through ResearchKit, Stanford University enrolls over 11,000 volunteers in a cardiovascular trial within one day.

• Bayer HealthCare creates a companion app with personalized tools to assist people on a specified drug in managing their multiple sclerosis treatment.

Integrating Digital Health Data: Getting StartedMore pharmaceutical companies are leveraging digital health technologies — wearables, clinical devices, sensors and applications — than ever before to improve clinical trials and the drug development process, ultimately allowing the more efficient creation of game-changing drugs that could have a significant impact on patients’ lives. The emergence of these technologies from a myriad of manufacturers has created interoperability challenges for sponsors in gathering the data and integrating them into trials. “I think the interoperability piece is key and a critical first step for integrating these devices into clinical trials, so as to meaningfully inform how we can improve outcomes for patients,” Duke’s Eapen said.

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and regulators become more comfortable with the technology, the challenge is likely to increase in the years ahead. Pharmaceutical companies that address the challenge today will be rewarded with a clinical trial model that can increasingly transfer the burden of gathering data from people to digital health tools. By easing the data-collection process for trial participants, it increases the likelihood people will enroll, stay engaged throughout the duration of the program and re-enroll in future studies. In turn, it can give a competitive advantage for sponsors, providing quicker enrollment, decreased dropout rate, shorter drug development timeline and, ultimately, significant cost savings.

“Once we can use digital devices to replace existing sources of data, it scales cheaper, it moves faster, it’s more progressive,” Reites said. “And that means we can actually leverage it to help bring more data in with more cost effectiveness.”

Fortunately, pharmaceutical companies don’t have to face this alone. Digital health platforms, like Validic, solve the interoperability challenge by enabling the easy integration of data from hundreds of digital health devices and applications.

Are you ready to integrate digital health data and advance your trials? To get started, contact Validic at [email protected] or visit validic.com.

About ValidicValidic provides the industry’s leading digital health platform connecting pharmaceutical companies, providers, payers, wellness companies and healthcare IT vendors to health data gathered from hundreds of in-home clinical devices, wearables and consumer healthcare applications. Reaching more than 223 million lives in 47 countries, its scalable, cloud-based solution offers one connection to a continuously-expanding ecosystem of consumer and clinical health data, delivering the standardized and actionable insight needed to drive better outcomes and streamline clinical trial processes including remote patient monitoring, recruitment and pre-clinical and post-marketing research. Validic was named to Gartner’s “Cool Vendors” list and received Frost & Sullivan’s “Best Practices and Best Value in Healthcare Information Interoperability” and “Top 10 Healthcare Disruptor” awards. To learn more about Validic, follow Validic on Twitter at @validic or visit www.validic.com.

“Once we can use digital devices to replace existing sources of data, it scales cheaper, it moves faster, it’s more progressive.” JOHN REITES, HEAD OF DIGITAL HEALTH ACCELERATION AT QUINTILES

https://twitter.com/validic

http://www.validic.com






june 2016 fiercemarkets custom publishing, in partnership...

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