Cloud-Based EDC Part II: 5 Tips for Successful Cloud Implementation

photodune-5055010-cloud-computing-sIn 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.

  1. 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?
  1. 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.

  1. 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.

  1. 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.

  1. 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. 





Disaster Recovery Planning: Is your Company prepared in the New Year?

recoveryHaving an effective and simple disaster recovery plan is essential for any company from an IT and business perspective. Is your company prepared for the upcoming year? ARITHMOS takes you through the essentials of disaster recovery planning.

Disaster recovery planning is absolutely essential, especially in an industry dealing with large amounts of data such as pharmaceuticals/healthcare, energy and gas and financial sectors. In cases of Disaster Recovery, most companies fail to understand the importance of IT services and personnel from a business perspective. As companies grow globally, they need to know exactly what IT services they are capable of providing, at what costs and what risks are involved in the geographic expansion.

What would the consequences be for you, your company and your clients if your IT shut down for an hour? For 2 hours? For a whole day? What would be your quantifiable losses? Who would be in charge of initiating data recovery? A good disaster recovery plan will involve all departments related to IT service and business activities to evaluate risks and costs.

A good disaster recovery plan starts with analyzing the risks…

The plan should start with a basic risk assessment of the physical location of a Data Center. Avoid building a Data Center where there is high risk of natural disasters. Human error is a different story. Employees can accidentally trip the power or delete important data. The first step in Disaster Recovery planning internally is to know your office building and employees and what can be prematurely avoided.

…and keeping business as usual…

A good Disaster Recovery plan will be well detailed within the “business continuity” plan. Can a company continue providing business-as-usual services while the disaster recovery process is in place?

DRP…by knowing your IT service capabilities…

The Disaster Recovery plan should identify priorities in terms of IT services – what is important and what is absolutely essential. Knowing the priorities of disaster recovery can help to:

  • Define levels of service needed
  • Estimate recovery time
  • Create a method of recovery

Once you have determined the priorities, the most important analyses will be the RPO (Recovery Point Objectives) and the RTO (Recovery Time Objectives). The RPO will establish how far back services will have to go to find recoverable data, and the RTO will determine how much time is needed for recovery. The Disaster Recovery plan must then be maintained through proper documentation and system validation.

A quick note on Computer System Validation

Computer System Validation (CSV) is a documented process for assuring that a computer system does what it is designed to do and CSV should be a part of your Disaster Recovery Plan. There are two important reasons for performing CSV on technologies and software: (1) CSV can prevent problems before reaching the usage environment, and (2) Not performing certain CSV in accordance with Best Practices could be against the law in certain industries.

ARITHMOS has extensive experience in providing consultancy for Disaster Recovery Plans and Computer System Validation. ARITHMOS can guarantee quality and secure hosting as well as data integration services and data center replication. To consult ARITHMOS’ experts, submit a request form or email us at