Seven Things to Look For in Clinical Trial ‘Software-as-a-Service’ Provider

With so much talk these days about the “Cloud” and “SaaS”, some of you may be wondering whether it makes sense to give a Clinical Trial web-portal a try.  For those unfamiliar with what SaaS (Software as a Service) refers to, it is simply software that is deployed to you over the internet. Typically, with SaaS, a provider licenses the application to customers as a service on demand through a subscription in a “pay as you go” model.  A popular example is ‘Salesforce’ for Customer Relationship Management.

As a study manager or site, you will want an honest assessment of the benefits and risks, and be realistic about whether going to the cloud makes sense.  Some of the reasons seem obvious, so forgive me for restating, but there are  some risks associated with using a Clinical SaaS platform. So what things should you ask your Clinical SaaS provider?

1. Is the provider secure and compliant?: This is the bare minimum requirement. Is the provider CFR Part 11 compliant? The system should be compliant with the regulations guiding the creation,transmission, and retrieval of electronic documents, as described in FDA 21 Code of Federal Regulations (CFR) Part 11.  The system should provide three levels of security:  system security, user access security and document security. System security refers to complying with the highest standards required to protect the sensitive information that is central to clinical studies. (think SAS-70 Level II certifications and compliance with ISO 9000 standards). User access security ensures the system has strict user ID and password controls, and that different levels of user access and control in the web portal can be assigned to different study participants. Document security include: locking the document to prevent substituting earlier versions, prohibition from copying, printing or forwarding to unauthorized individuals, and watermarking, for additional security. These features give sponsors the confidence to freely share information among stakeholders.
2. How user-friendly is the solution? From the perspective of the end-users (or site personnel), the web portal must be a user-friendly technology that can be easily embraced in the transition from paper-based studies. Appropriate training and support, (eg online tutorials and a 24 hour live help desk) should be part of the package. Ask the provider if they offer a free trial demo – they should! While playing around with the system, ponder on how user-friendly the system really is.  Do you find yourself struggling when trying to accomplish a task? Do the labels make sense? Can you find your way around the portal easily? A good example for “user friendly” is the user interface of the iPhone – something my 2 year old daughter figured out in seconds.
3. Am I getting the right “bang for the buck?” There are three key drivers in cost savings when using SaaS: money saved from eliminating overnight document mailing, time savings managing tasks (rule of thumb is two weeks saved in study start up) and money saved by not having to purchase servers or other software to support use. If the total cost savings from these three drivers are greater than the cost to use the SaaS solution, then you’re in the ballpark.
4. “How much support can I expect?” The provider should offer 24/7/365 live global support in multiple languages.
5. “Are you neutral?” The provider should not be tied to any one (or handful) of sponsor or contract/clinical research organizations. Obvious, but you should ask.
6. “Will I be able to integrate your solution to my existing systems?” The provider’s solution should be able to integrate with your backend systems. Ask if the solution is CDISC compliant and whether you can export your information easily.
7. “How much experience does the provider have?” Ideally, the software providers should have a proven track record of  working on numerous projects. If not, check the backgrounds of the software programmers and the subject matter experts on hand. The SMEs should be folks who have extensive experience starting and managing clinical trials.

And finally, be wary of any provider that is over zealous in their passion for SaaS.  I’m referring to folks who seem to just have a positive spin on any question you throw at them. Let’s be realistic. No software is perfect. And yes,  SaaS does show promise, but until it’s more fully baked, be methodical and measured in how you approach implementation.

Jae C.

About Me

I am the founder of goBalto, the easiest way to start your clinical study on the web. Before goBalto, I co-founded,Celltrion, a leading biopharmaceutical supplier and earned a paycheck from McKinsey & Company. I’m a father of 2, with a 3rd on the way – scheduled for October. I believe drug development can be made more efficient using simple, easy to use yet powerful online tools.

Tagged as: cloud, saas