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Clinical trial statistical computing & the Cloud: Implementation

Once you’ve set down a plan to embrace hosted SAS for managing clinical trial data, what are the main factors that should drive and smooth your cloud implementation?

IDC predicts that by 2020, more than two-thirds of all enterprise IT infrastructure and software spending will be cloud based (IDC FutureScape: Worldwide IT Industry 2017 Predictions) - a natural progression as organizations accept that this is the best way to access the latest capabilities, and the capacity and processing power they need, and as they become more confident in cloud’s robustness and security.
 
But what’s involved in implementing a hosted software solution for the first time, if you’ve previously only run in-house systems on your own servers?
 
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If you’re expanding, updating or adding a SAS clinical trial statistics capability and are attracted to the many benefits of running this via the cloud, there are some important considerations to ensure the hosted service delivers everything you need, with no unpleasant surprises.
 
See beyond the software
 
The best approach for something as important as clinical trials data handling and system compliance is to pick your provider carefully. You’ll need to choose a company that understands the particular software, its use and importance, and the requirements that are specific to your market – for example proof that systems adhere to industry standards and can be relied upon for their accuracy and integrity.
 
If the part of your organization that’s using the software has limited IT expertise, and/or lacks ready access to sufficient internal IT resources, you’ll be placing a lot of trust in your SaaS partner - so make sure they stand up to scrutiny and can satisfy all of your broader needs. Remember, this is about more than a software provision arrangement – the software also has to do the job it’s required for. Without this certainty, you could be sacrificing too much in the pursuit of the promised benefits of cloud IT provision.
 
Be realistic about what’s involved
 
Unless the functionality you’ll be accessing is very simple and standard, it would be naïve to assume that accessing the new SaaS facility will be a case of flicking a switch.
 
You’ll need to allow for:
 
Data migration & some minor system configuration
 
Existing data may need to be migrated to the hosted system, and settings configured to your specific needs. There are likely to be integration issues too. Unless the SaaS system stands alone, it will need to accept data feeds from other applications, and be able to provide data back to other systems. So all of this needs to be thought through and planned for.
 
Security & data protection
 
Security and data privacy considerations will also be important. Where will the data be physically stored, and who might have access to it? Will this pass life sciences and wider patient protection regulations? Are there extra measures you might need to implement to satisfy industry requirements? Again, the right provider – someone who understands the demands of the life sciences market – should be able to advise about how the new set-up will work with your broader IT infrastructure, and offer assurances about data safeguards.
 
Delineating responsibilities
 
You’ll also want to check how responsibility will be divided between the SaaS service provider and your organization. Where will their remit and accountability begin and end, and is there an option to extend this? If so, what are the additional cost implications?
 
Contingencies
 
In the unlikely event of a technical problem, what would happen and what cover/contingency measures are provided? Are these adequate for your requirements, or will you need to negotiate a faster response rate or an alternative process for accessing data while any issues are rectified? Again, what is required as part of regulatory compliance? Does the service being offered match those criteria?
 
Measuring benefits
 
Next, how will you measure performance and benefits? Your planned use of the cloud will have been driven by expectations about certain benefits. How can you be sure these will be delivered? What is provided for in the contract, and will you need to tailor this? If so, will this incur additional cost?
 
One of the main benefits of a SaaS service is that the total cost of IT ownership should be lower, but if you have to ask for lots of system modifications to meet very particular needs, this could bring those costs back up. So weigh up the extent to which you will want to tweak the standard workflow and the way the software looks and feels to your users. Nothing is impossible, but be careful not to undermine the business case.
 
Get the timing right
 
Finally, as you approach the transition, make sure you are allowing plenty of time to get everything right – for data to be migrated, and for everything to be tested. And make sure you’ve made a plan for what happens in the meantime, while the transition is happening. Is there a good or bad time to do this?
 
Some of these considerations may sound onerous, but it’s better to be prepared. The promised gains of cloud and SaaS are very real, but there is work involved to get to that point. With the right help from a suitable provider, you should have everything covered and your load could soon be a lot lighter.
 
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