In Part I of our blog on cloud-based EDC, we discussed reasons why companies conducting clinical trials should consider a cloud-based approach to electronic data capture. Not only can a cloud-based solution speed up a clinical trial (reports have demonstrated up to 30%), but it can also result in considerable cost savings (to the tune of up to $400 million USD in some cases).
So, if your company is now convinced to go the cloud computing route, how can you prepare for successful implementation? ARITHMOS offers 5 tips to ensure your cloud-based EDC implementation is a success.
- Know the questions to ask your cloud services vendor
Cloud computing may sound simple. Establish an Internet connection and share data across networks. However, if you are considering a cloud approach to EDC, it is critical to know whether your vendor has previous experience and what additional support and security services they provide. Here are some questions to ask your vendor:
- What is your previous experience in implementing cloud-based EDC?
- What is your procedure towards network connectivity?
- Do you implement a risk-based approach to implementation?
- What are your data security procedures?
- Does your IT team include a business analysis expert and a compliance expert?
- Perform a Business Analysis with your IT Vendor
It is important to know what your business objectives are with a cloud-based EDC solution: faster clinical trials? More efficient data management? Better data quality? Reducing costs?
Discuss these objectives with your IT Vendor and perform a business analysis which will help you define your user requirements. This will allow the vendor to implement a solution customizable to your trial needs.
- Search for Pay-As-You-Go or Pay-Per-Use Options
If budget constraints are a primary concern for your company (as it is for most companies conducting trials), look for cloud-based EDC solutions that have pay-as-you-go options for features used or even pay-per-study options. This is achievable in the cloud since there is no software or hardware to install. Therefore, Sponsors can define Service Level Agreements that meet their needs and budgets and increase or decrease functionality as needed.
Again, consulting your IT vendor prior to implementation to define user requirements will help you create a cloud-based solution that caters to your specific, or in some cases minimal, needs to satisfy your budget.
- Disaster Recovery Plan, Business Continuity & Cloud Compliance
A Disaster Recovery Plan is absolutely crucial to a cloud-based EDC approach. In a cloud-based world that is dependent on virtual databases, having a backup plan is vital. Discuss a disaster recovery plan with your IT vendor and know exactly what their plan is for power failure, network failure, server damage and backup data centers.
Be sure to implement the following procedures with your IT vendor:
– How will computer system validation be handled?
– How will Installation Qualification be handled?
– How will change control be handled?
– How will encryption be handled?
– How will regulatory inspections be handled?
More importantly, does your provider have a business continuity plan in place to ensure that the organization continues to operate despite any major incidents or disasters.
- Implement a Configurable Solution
Cloud-based solutions, in addition to being software/hardware free, also come with a great deal of flexibility. The following points can be considered in a configurable solution in order to save time and costs:
– Ability to reuse the application with slight modification
– Reuse of documentation
– Training effort kept to minimum due to high usability
– Sponsor and site personnel use the same application for different studies
– Ease of managing study personnel credentials
Check out ARITHMOS’ website for more information on our cloud implementation services and computer system validation support.