Pioneering Cloud Computing for Clinical Trials Marc Desgrousilliers, Chief Technology Officer at Clinovo Olivier Roth, Marketing & Communication Coordinator 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 Tel: (800) 987-6007 Fax: (888) 317-7517 contact@clinovo.com August 2012
THE CLOUD: A NEW PARADIGM The cloud generated $36.1 billion dollars in 2011 and is expected to reach $72.8 billion by 2015 according to a recent IDC study. With a CAGR of 21% per year from 2011 to 2015, the cloud is growing three times faster than traditional IT infrastructures. It is nowadays a commonly known revolution, yet very few people grasp the nuances and the potential behind this term. In simple words, the cloud turns everything into easily accessible and affordable services, unleashing unmatched potentials for organizations and individuals. DEFINING THE CLOUD The cloud is the ability to access value-added services from anywhere at any time with a level of simplicity, flexibility and cost efficiency never met before. The cloud provides on demand access to software/applications, platforms and infrastructures commonly known as: - Software-as-a-Service (SaaS) such as web hosting services, collaborative or CRM applications such as the well-known Salesforce.com. - Platform-as-a-Service (PaaS), providing developers the tools to develop their own applications such as databases, operating systems, etc. without any initial costly IT investment in hardware. For example Google s App Engine is a PaaS enabling developers to create new applications. - Infrastructure-as-a-Service (IaaS) enables access to computer infrastructures such as servers, data-centers and network equipment, once again without any heavy initial investment. This type of cloud service is often used by organizations that have the IT expertise to manage their IT requirements but not the infrastructure itself. For example, Amazon s Elastic Compute Cloud (EC2) provides resizable compute capacity to make web-scale computing easier without the need for CAPEX. Those three categories are called services in the sense that users access, subscribe, use, monitor them on an on-demand and pay-as-you-go basis. The user can monitor the Service Level Agreement (SLA) he signed for, submit tickets if necessary, look at its IT usage bill on its own, without any human interaction. The cloud is thus a very automated, elastic and cost-efficient environment. This level of autonomy is possible thanks to processes automation: Workflows are automatically processed in the cloud without human intervention. The advantage of process automation is costefficiency since less IT hours are billed. Today, around 70% of IT budgets are spent on maintaining the infrastructure, leaving only 30% for new projects. This tends to frustrate departmental managers who see their projected queued, sometimes for years. The cloud provides an immediate and cost effective solution while empowering these managers. 2
CLOUDS RATHER THAN CLOUD Traditionally the cloud is split into four types: Users Characteristics or Individuals Public clouds are the most common and can be used by organizations and individuals. There are around 100 million users on the public cloud. Anyone can access well-known public cloud services via the Internet. Well-known examples are Google applications or Amazon Web Services. Private clouds are mostly used by organizations. It provides more control and more safety of the data as it is hosted on site rather than on external servers. A private cloud can be accessed on the web, but the data is secured and controlled behind the organizations firewalls. SUNGUARD, rackspace and terremark, among others, provide these types of private clouds. Hybrid clouds are a fast growing type of cloud. They are connecting private clouds and public clouds. The benefit is to access public cloud services while ensuring the safety and control of a private environment. The sensitive data can be hosted on the private side while enabling access to features on public clouds. Thus, the Hybrid cloud is a way for IT to keep control over sensitive data, while answering users demand for public cloud services. Community clouds are a private form of clouds, yet shared by multiple organizations in an industry. They are limited to defined users who share common resources. For example, Clinovo provides community cloud-based hosting clinical application services for its clients. CLOUD TECHNOLOGY IN THE LIFE SCIENCE INDUSTRY Clinical trial professionals already use public clouds but mostly for administrative, IT, marketing or sales purposes (such as Google Drive, any document sharing system or CRM tools) but very few of the cloud services are directly related to life science. Although cloud-based systems are gaining momentum in almost all the industries, the adoption rates for this innovative technology remain low in the life science industry. Some IT vendors in clinical trials such as Medidata Rave are arguing they are offering cloud services, whereas their services are neither self-service nor on a pay-as-you-go basis. This is not uncommon; many 3
companies exploit the cloud marketing buzz, yet provide services that are not self-service, automated, flexible nor cost-efficient. In clinical trials, cloud technologies are a new opportunity to lower skyrocketing costs. Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) or epro systems would be configured and implemented at a much faster pace and at a much lower cost. In January 2012, Forbes calculated the average cost of bringing a new drug to market at $1.3 billion (at times $4B to $11B for big pharmaceutical companies), this calculation takes failed drug application in account. Thanks to the always-on and automated properties of the cloud, drug development cost is bound to decrease since clinical trials will be started and ended faster than ever before. UPCOMING CHALLENGES One of the major concerns of pioneering cloud computing for the healthcare industry is compliancy. Pharmaceutical companies must ensure that the cloud service providers they use follow GCP as guided by 21 CFR Part 11 regulation, to ensure the system is fit for its intended use; including IP/IQ (Installation protocol and qualification), OQ (Operation qualification) and PQ (Performance Qualification). Here are some tips about validating a clinical application in the cloud: You must have an installation protocol to install the application into the cloud; as well as for every minor and major version upgrade. In a public cloud you cannot have an installation protocol for installation of the hardware and OS images. More and more auditors understand and accept this is a limitation of the cloud. Do check with your QA department, if in doubt. You must provide test and production environments for each application in the cloud. You must test backup and restore of all production applications. It is a good idea to test your disaster recovery procedures. You may need the cooperation of your cloud provider to simulate a disaster for you. Validation of the application must take place in the cloud and you must use the same documentation and methods as if the application was running on a local server. Since clinical trials are more and more international, there is also a need to ensure that local regulations are followed. For example it is essential to know where the data is hosted. Indeed some countries require the clinical data to be hosted in the actual country of the clinical trial. For example, if a pharmaceutical company runs a clinical trial both in the US and in Japan, the Japanese data must be hosted in Japan. This regulation should be taken in consideration while implementing a global cloud-based clinical system. Even though the cloud is promising autonomy, flexibility and cost-efficiency for pharmaceutical companies, there is a need for experts to ensure that the transition to cloud-based services for clinical trials is made in a safe and compliant manner. IT and life science are two very different areas 4
of expertise, so it is critical to take the time to choose a vendor that has proved its worth in both area and that can guide you through this new technology. Ultimately, the cloud technology will revolutionize the healthcare and life science industries, enabling pharmaceutical companies to bring their drug to patients faster at a lower cost. At Clinovo, we pride ourselves to seek and bring the most innovative technologies and apply them to the life science industry to streamline clinical trials. Our team is composed of experts in both the IT industry (link to Marc s bio) and the life science industry (link to Jean s bio). CONTACT INFORMATION Your comments and questions are valued and encouraged. Contact the authors at: Marc Desgrousilliers CTO at Clinovo 408-773-6251 marc.desgrousilliers@clinovo.com www.clinovo.com 1208 E. Arques avenue, #114 Sunnyvale CA 94085 Olivier Roth Marketing & Communication Coordinator at Clinovo 408-940-3941 olivier.roth@clinovo.com www.clinovo.com 1208 E. Arques avenue, #114 Sunnyvale CA 94085 5