Cloud Computing in Clinical Trials - Part II

December 31, 2014 Mika Nuutilainen

In the last blog article I discussed the definition of cloud and its advertised benefits. In regard to clinical trials data, the biggest problem with cloud services is that there is no easy way to ensure that data really will stay unaffected when stored in the cloud service. How could I be assured that no other application, person, or service will change my ePRO data? And how could I guarantee the FDA the same.

Major cloud computing service providers do have security certificates, but it is still uncertain for a customer how well the data is really taken care of. Cloud service providers have developed their processes to provide service within minutes and completely automatically.  So IQ, OQ, and PQ (system validation steps) with objective evidence could be hard cases to provide for in all server installations. When your servers are provisioned and deployed as virtual machines in the cloud, validation of your installation in the way we are used to is not possible anymore.

In April 2011 part of the Amazon EC2 cloud service was down for several days. It was widely broadcast in the news, especially since many well-known social media services using EC2 were down through the whole break. These companies included Quora.com, Reddit.com, GroupMe.com, Scvngr.com, and foursquare.com. And when the service was finally restored, Amazon declared in the aftermath that they had lost 0.07% of data. That does not sound like a huge amount, but considering it has been estimated in 2010 that Amazon EC2 contains 1.8 million server instances, the amount of lost data cannot be ignored.

cloud computing crf healthAll top 5 cloud providers have suffered unexpected downtimes (Amazon EC2 in April 2011, Rackspace has had multiple power failures over the years, salesforce.com in 2009, Google Apps multiple times over the years, Microsoft Azure for 22 hours in 2009). Some have had serious power failures and some connectivity issues, but all biggest cloud providers have had disruptions, and are likely to have them in the future.

Cloud services provide a fast way for small companies to launch a new product and also allow them to focus on developing product features instead of fine-tuning the servers. Also cloud enables them to increase server capacity immediately when needed. With cloud there is no need to invest on big server farms, basing decisions on uncertain sales budgets. Or to suffer from poor service quality when a service becomes too popular and servers cannot handle all the requests. When analyzing if an already set-up and well working service should be integrated into a cloud, it is not so straightforward; there has already been a lot of money invested on your servers and other infrastructure.

It is clear that in the long run the cheapest way of buying server capacity is to buy instances from a cloud, so it is inevitable that clouds will be used in clinical studies too. But it most probably means that a specific clinical cloud will be implemented for that purpose. Clinical requirements are so tight that in order to fulfil them, no cloud provider would be interested in making their whole cloud compliant. In order for such a clinical cloud to be created, a lot of process harmonization and co-operation will be required between Sponsors, CROs and trusted 3rd party providers such as CRF Health, and some well trusted and established IT provider to make this happen. 

For a well-established system, integration to a cloud server and storage system could be considered when a new step is taken in business or when the whole existing infrastructure is being upgraded. There are no cost savings easily obtained when replacing existing hosting centre and dedicated servers with a cloud.

Meanwhile, CRF Health continues to have well working dedicated TrialMax® servers and trained professionals to keep them running and providing good quality service 24/7, day after day. And when you ask who guarantees that your data is protected – we can honestly say that we guarantee it – and are really in a position to do so.

Best Regards,

Mika Nuutilainen
Director, Product Development, CRF Health

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