Top 10 eClinical Trends

Olivier RothThe drug development industry is facing a revolution in the way clinical trials are being planned and conducted. It’s an industry that experiences rapid changes in technology adoption and business models, from new ways of capturing clinical data to new outsourcing strategies. This paper focuses on ten essential eClinical trends in order to help you understand which direction the biotech industry is prone to take in the next few years.

As both the means, and the ultimate motivation of clinical development, patients are the most fundamental assets during the clinical trial process. We have summed up five trends that are destined to give them a more important role in the conduct of clinical studies: Boosting Patient Engagement, Integrated ePRO (electronic Patient Reported Outcomes) Systems, Mobile Clinical Studies, Personalized medicine, and Risk-based monitoring.

The “Cloud” is giving Pharma companies the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility, and cost-efficiency never seen before. In other words, the “Cloud” is the technology that allows you to use a service on-demand, as and when you want, as well as pay for what you use and only what you use. How will cloud computing bring Scalability to Big Pharma, and Cost-savings and usability to Small Pharma?

Finally, the ways sponsor companies and Contract Research Organizations (CROs) collaborate are being reshaped by new technologies and innovation-driven business models. Some companies are securing Intimate long-term partnerships, while other are relying on Flexible short-term models to complement their expertise and help them grow faster.

Patient-Centered clinical Studies

Trend 1: Boosting Patient Engagement

Patient engagement is critical in ensuring the success of clinical trials. Pharmaceutical, medical device, biotechnology, and diagnostics companies are constantly searching for new strategies to boost enrollment. MD Charles B. Simone, Chief of Thoracic Oncology and assistant professor of Radiation Oncology at Penn’s Abramson Cancer Center, led a willingness to participate study in an oncology clinical trial with the results being published in October 20131. Dr. Simone found that one of the key success factors was spending more time with patients to thoroughly discuss the details, logistics, risks and benefits of enrollment. This simple formality gave patients a better understanding of the proposed study and thus empowered them.

Life Sciences companies and organizations are also relying more and more on the Internet to spread their message and engage patients. We are witnessing the development of dozens of websites that introduce targeted populations to clinical development. For example, The National Institutes of Health (NIH) has created a new website, ‘NIH Clinical Research Trials and You’ to help people learn more about clinical trials, why they matter, and how to participate ( The use of social media networks to engage and enroll patients is another winning strategy that is predicted to gain momentum in 2014.

Trend 2: Integrated ePRO (electronic Patient Reported Outcomes) Systems

Technological innovation is also placing the patient at the epicenter of clinical research. Fast-developing ePRO technologies allow patients to report clinical data themselves. The modern ePRO systems are designed to maximize the ease in which patients report their observations. Additionally, they better integrate with eClinical systems to capture and spread relevant clinical data faster to clinical teams. For example, ePRO systems integrate with Electronic Data Capture (EDC) systems to automatically and securely import clinical data from the ePRO directly into the EDC system. This allows a quicker response time in the case of adverse events for example.

Trend 3: Mobile Clinical Studies

Mobile and wearable devices show great potential for patient engagement. Unfortunately, in 2014, it is still a largely untapped use case. Data-rich mobile and wearable devices are bound to play a growing role in clinical trials in the years to come: They can be seen the next evolution of ePRO systems. Consider that mobile device allow patients to report clinical data on the fly, perhaps without even thinking about it. For example, physical activity of a patient can be measured and transmitted to clinicians in real-time by leveraging new smartphone applications.

Much of the tech already exists for a truly mobile-driven clinical trial. Patients with insulin-dependent diabetes will soon be able to use Tidepool’s Blip app2 to aggregate glucometer, insulin pump and continuous blood glucose monitor data and transmit it to their providers. Such devices will undoubtedly accelerate clinical trials and the quality of the data if used appropriately. The challenge for the industry is to appropriately regulate the use of these devices in clinical trials, so that the collected clinical data can be leveraged by Food and Drug Administration (FDA) reviewers.

Trend 4: Personalized medicine

The revolution of personalized medicine has made a considerable leap in the last few years with the gradual democratization of genetic testing. The company 23andMe envisions giving everyone access to their own genetic data. Even though the FDA recently asked the 23andMe to withdraw their genetic testing device from the market, the prospect of examining a person’s entire genome, or at least a large portion of it, to make individualized risk predictions and treatment decisions is now within reach.

In 2013, the FDA has also issued a report detailing how it intends to regulate personalized drugs and devices3. The upcoming revolution of personalized medicine will encourage the upstart of smaller clinical trials, and thus an increased importance to individuals in clinical development.

Trend 5: Risk-based monitoring

Risk-based monitoring methods and processes are likely to command more and more importance. For example, Clinovo unveiled a risk-based monitoring module at the latest Outsourcing in Clinical Trials West Coast Conference, which further extends the capability of our open source EDC system ClinCapture. ClinCapture was integrated with Patient Profiles to create individual reports for each subject. It allows anyone (with or without a clinical, statistical, or programming background) to easily review each patient’s time on study, identify errors in data, and observe efficacy. Patient Profiles automatically runs algorithms to mine your clinical data and identify data that is unusual. The rules are inferred from the data without needing to hard code the error checks.

Cloud-Based Clinical Trials

The “Cloud” gives the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility, and cost-efficiency never seen before. In other words, the Cloud is the idea that you can use a service on-demand, as and when you want, and pay for what you use and only what you use.

It is becoming critical for the drug development industry to adopt new methods to deal with the ever-growing flows of clinical data; Industry analysts estimate that the data generated by the pharmaceutical industry doubles every six months. However, the drug development industry is still in the early stages of evaluating the applications of Cloud in its field.

One of the first applications to come to mind is the use of cloud computing to capture and manage patient’s clinical data across large clinical studies. Many foresee the emergence of “Cloud Data Capture” gradually replacing Electronic Data Capture (EDC), among other eClinical systems.

Trend 6: Scalability for Big Pharma

In the Cloud, data is available in real-time from anywhere in the world, and the rapid elasticity afforded to cloud-based hosting solutions can virtually offer infinite scalability. Users are able to expand the volume of memory or bandwidth needed in a just a few clicks without having to rely on IT or knowing any programming. Thus it becomes logical for Big Pharma to look into Cloud technologies as these beneficial features correspond directly to the issues they face. In July last year, FierceBiotech4 reported that in 2013, Pfizer was pushing the use of Cloud computing for supporting an online clinical trial system developed internally. It should be noted here that many believe it is in the best interest of the Pharma industry (as big as they are) to rely on external vendors and open source software as far as novel eClinical technologies. Unsurprisingly Pfizer has since abandoned the project.

Trend 7: Cost-savings and usability for small Pharma

The Cloud is also of great interest for small to mid-sized biotech, medical device companies, as well as universities. The introduction, and growing adoption, of Cloud technologies for clinical trials is also bound to lower the cost of technology and thus the barrier to entry.

Considering that the adoption of Electronic Data Capture (EDC) systems has remained slow in a number of segments of clinical research (only 40% of Phase I clinical trials had adopted EDC by the end of 2012) we can argue that there is a long-lasting barrier to entry for EDC. It could be argued that this is almost certainly due to the cost of acquisition for the majority of systems on the market and the complexity and changes required in technology. Cloud service providers for the pharmaceutical industry need to tackle this challenge, and make technology available and affordable for smaller companies, where resources are limited but where innovation blossoms. Ultimately, it is my belief that the Cloud will revolutionize healthcare by enabling pharmaceutical companies to bring their drug to patients faster at a lower cost.

The Changing Landscape of Outsourcing

Trend 8: Intimate long-term partnerships

According to Parexel’s President Mark Goldberg5, there is a trend toward relationships between CROs and sponsors becoming more intimate and strategic. More and more, CROs are engaged to deliver technology and expertise, not just short-term resources. I think this is particularly true for big CROs and large sponsors, such as the known partnership between Parexel and Pfizer. Bayer reported in Clinical Leader6 that one of its success stories is their partnering agreement with Covance, which Bayer now use as a key example of how to successfully execute partnerships. Large players now have more visibility in their pipelines and are constantly looking to form long-term partnerships as they plan their drug development efforts for years to come. It makes sense for big companies to rely on experienced CROs to help them streamline their processes.

Trend 9: Flexible short-term models

How about the small- to mid-sized sponsors companies? The Functional Service Provider (FSP) model has proven to be an effective tool in reducing costs for small to mid-sized players. From our experience at Clinovo, we can estimate this model can save 30-40% on direct cost savings on top of larger indirect cost savings. The flexibility, speed of implementation, and ability to scale up or down projects rapidly has been attracting small to mid-size pharmaceutical, medical device and diagnostic companies to the FSP model.

Trend 10: Innovation-driven outsourcing

With study designs becoming increasingly complex, sponsors are becoming more reliant on eClinical systems to handle complex protocols as well as handle ever-evolving regulatory requirements. Innovation amongst CROs and software vendors will continue to scale up in 2014, with a focus  on broadening and streamlining access to relevant data, tempering the risks associated with clinical trials, and increasing the predictability of success or failures.

More game-changing start-ups are changing the way CROs and sponsors collaborate through technology. GoBalto and Comprehend Clinical can be clearly identified as two examples of disruptive innovation in the industry, creating value for sponsor companies. Their solutions aim at making access to critical data easier, providing turnkey solutions to empower sponsor companies without having to hire, maintain, and manage a large number of resources and programmers. GoBalto’s flagship product, Tracker, is a software-as-a-service clinical research platform. It enables clinical trial sponsors and research organizations to track milestones on the critical path, and provides document workflow management capabilities in a transparent, regulatory-compliant, user-friendly way.

Comprehend Clinical, also providing a cloud-based system, is serving real-time analytics across complex clinical data, independent of data source or format. It enables sponsors (mostly large pharmaceutical companies) to quickly answer questions and discover discrepancies from any device.

Clinovo is aiming at helping small to mid-sized sponsors access advanced technology in order to streamline their clinical trials. We are currently seeking funds for CloudClinica, Clinovo’s next generation Cloud-based eClinical platform. CloudClinica is an easy-to-use, pay-as-you-go platform to build and manage clinical studies from the ground up without any programming skills. CloudClinica will remove IT dependency, and allow smaller pharmaceutical, medical device, and biotechnology companies to access sophisticated eClinical systems.


  1. “Willingness to participate study” by  Charles B. Simone, MD, chief of Thoracic Oncology and assistant professor of Radiation Oncology at Penn’s Abramson Cancer Center, October 2013.
  2. Tidepool - Acquiring, Storing, and Opening Data for Improved Diabetes Care, by John Walsh, PA, CDTC, Ruth Roberts, MA.
  3. FDA Lays Out Framework for Regulating Personalized Drugs, Devices, 11/18/2013.
  4. Where is cloud computing a fit in pharma? July 2, 2013 | By Ryan McBride.
  5. Intimate partnerships: Parexel President shares CRO trends for 2014, 02/10/2014.
  6. Bayer And Covance Data Management: How Partnerships SHOULD Be Done, by Ed Miseta, chief editor, Outsourced Pharma and Clinical Leader