Q: What Impact Do You Think the Move to Cloud Computing Will Have on the Ability of Contract Service Organizations to Better Meet the Needs of Their Customers?

Cloud Computing

Mike Irene, Vice President, IT Delivery,
PRA Health Sciences

A: The adoption of cloud computing within contract service organizations provides agility, increased scalability, and better performance for meeting the needs of life sciences customers. At PRA Health Sciences, we have woven cloud computing into the fabric of our overall technology strategy including a broad array of solutions leveraging software, platform and infrastructure-as-a-service capabilities. With internal expertise as an early adopter and the support of a maturing vendor ecosystem offering a variety of cloud environments, we have realized enhanced external collaboration and more predictable delivery timelines for patient recruitment and data capture, project management, learning management and other mission-critical clinical systems as compared with on-premise options. Elastic cloud capacity enables deployment flexibility to support our global staff, clients and partners in more than 80 countries. We are seeing opportunities to host applications and also store and analyze vast quantities of data collected during a clinical trial.

Paul Labas, Director, IT Compliance and CSV,
IPS-Integrated Project Services, LLC

A: Utilizing cloud computing would allow CROs to provide their customers with more comprehensive, flexible, targeted and faster services for a fraction of a cost of going a non-cloud route.

Cloud computing offers CROs the ability to select their solutions from a wide array of existing choices; begin using cloud infrastructure or systems without the need of going through (often cumbersome) builds and implementations; scale the solution delivery and costs according to the current needs; utilize existing vendor controls such as disaster recovery, security, automated updates, etc.; and allow access to data and systems from any connected device, etc.

The cloud computing business model of investing heavily into building sophisticated computing infrastructure and systems, and providing users with access to such resources for a fraction of the total cost, clearly benefits cloud users and allows them to pass improved services and lower costs to their customers.

The benefits of using cloud computing in the CRO space are not any different from utilizing the cloud in any other space, and can be safely achieved as long as the CRO remains vigilant when addressing considerations and challenges that are unique to life sciences–regulated environments.

Simon Lane, Vice President, Information Technology,
Altasciences Clinical Research

A: I think the principal impact of the move to the cloud for many applications and services is the flexibility it adds to organizations to adapt to their clients’ needs. Without the need for large legacy systems, and with the proliferation of offerings available, cloud computing provides agility to CROs that has not been seen before. The historical evolution of CRO systems has been a very slow, on-premise, waterfall progression. All of a sudden, these legacy systems are being replaced by one or multiple vendors that offer what are — in the CRO world — revolutionary developments. Furthermore, the advent of SaaS models allows the smaller player to be able to offer the same level of computing services as their much larger rivals from the start, something that was previously almost impossible. Likewise, the large CROs also have greater flexibility in what they can offer their clients. There is no requirement to invest a large amount in their own infrastructure in anticipation of the market; the infrastructure is already available, and this provides the CRO with the ability to service clients and requirements that were previously out of reach. Cloud computing is a game-changer and it is here to stay.

Stefan Peterli, Ph.D., Vice President of Strategic Business
Development, Minafin S.P.R.L. 

A: Cloud computing will help us to become more efficient and focus on our core business of delivering APIs while externalizing certain tasks such as mail, domain controller, web hosting and payment solutions. IT in support of core activities such as production and analytics will continue to be operated in-house for performance and confidentiality reasons.

Justin Schroeder, Executive Director of Marketing, Business
Development & Design, PCI Pharma Services

A: Cloud computing is certainly a growing trend in technology and making headway into the contract pharmaceutical-services market. It has established a presence in project management applications and information sharing, training and compliance applications and the emergence of many others. From a corporate IT perspective, being a highly regulated industry, there is always strong consideration for risk mitigation and application of robust data security for situations where the use of the cloud is an off-network third-party option. That is why cloud computing has probably seen slower adoption in our market as compared to more progressive technology-driven businesses. That being said, probably the biggest application we see for true third-party cloud computing is in logistical supply chain management. Our services are one facet of a complex supply chain, and cloud computing helps connect the dots to help provide end-to-end visibility.

One application in the clinical trial space is in Interactive Response Technology (IRT). IRT is commonly the interconnected hub of information that allows clinical trial stakeholders to monitor and progress the execution of clinical trials. The IRT system provides the central pathway for individual investigational sites, CROs who are administering the trial and collecting data; clinical supply companies like PCI Clinical Services who are preparing and delivering the medicines; courier companies; and sponsor companies to exchange information, monitor patients, order and enable transactions for supplies, share data, etc. These various groups and locations are commonly all over the world, and it is necessary to ensure that the data being exchanged is blinded (and often randomized) to guarantee the integrity of the trial. IRT is the central connected hub network that ensures that trials are executed efficiently and effectively with a multitude of touch points.

Ralf Liedke,IT Director Germany, Aesica 

A: We are excited about the benefits that cloud computing can bring. Primarily it will offer greater flexibility and access to numerous IT applications used by customers, in addition to the potential to significantly improve data transfer. Applications will be more scalable, which will benefit everyone, and there will no longer be a need to build up an expensive infrastructure if your demand is increasing. There are the added benefits of being able to book high-demand systems and, of course, that system and/or version updates can be planned and performed externally. Overall it will help reduce the IT administration burden, especially on backup and hosting maintenance, etc. 

Ramesh Subramanian, Ph.D., VP, Strategic Marketing and Global
Head, Business Development, Piramal Discovery Solutions

A: Cloud computing has been around for a while. However, its adoption by the pharmaceutical industry has taken longer than expected. Cloud computing has changed the way service providers and sponsor companies work, especially in terms of data transfer and security. Service providers have been challenged over the years to handle large volumes of data and documents associated with client projects. Due to increased outsourcing over the last decade, considerable efforts were required to maintain documents for each project, including those spanning various clinical phases. Cloud-based solutions allow for continuous and transparent content management. They facilitate sequencing of information based on timelines, dates and versions, while also assuring data integrity over the long run. They also allow for customers to access these documents at any point in time, thereby easing the burden during regulatory audits. Customers can also access cloud platforms 2-3 years after the completion of a project. This helps minimize any discontinuity that may arise due to the exit of a team member. At Piramal, we have implemented cloud-based solutions for some customers and found that they simplified the data management process for both our collaborators and our project management teams. 


 

Simon Lane

An avid (albeit not very good) golfer and, previously, a world class squash player, Simon has more than 20 years of IT operational, security and audit experience in companies A5:X92hat range from billion-dollar industries to five-person start-ups. He has worked with many pharmaceuticals and related companies and believes that compliance and IT agility are not contradictory, but can be made to work together to allow IT to be the business enabler it must be.