The purpose of this blog post is to summarize a model for ‘integrating’ clinical operations. I’ll summarize the goals for this model and describe the background and next steps around such an offering. Over the past few months I’ve been engaged with several clients in discussing how our IT Services Company could create such a platform. This new platform should meet the following:
- Lower Operating Costs
- Increase Productivity
- While maintaining Quality and Compliance
There are several very good software solutions yet we know that there is a lack of an ‘integrated’ process that can ‘unify’ the R&D clinical data landscape of IT solutions. The key here is a focus on ‘transformation’ rather than ‘yet another technology implementation.’
In a earlier blog post titled “Improving the Business of RandD” (31Mar2011) the focus was on cloud computing and how this technology could lead to an ‘integrated’ business process. Since companies would be relying on IT Service providers to host these applications. In another blog post “Is It Time for “ERP for RandD?”” (30Apr2011) I spoke to the need for integrated business processes. Now I’ll look to pull these to thoughts together for a more complete view across clinical operations.
Let’s start with the Users
This integrated approach would address users that include Pharmaceutical companies, Clinical Research Organizations (CROs), and any Healthcare entity. We would leverage cloud computing solutions to offer the users with a portal that supports:
- Single point of information capture
- With access to data by role, study and function
- Single sign-on
Content Layer
Here there is a dedicated source of content by pharmaceutical company. Various databases would be organized with content ranging from electronic data capture (EDC) to clinical and scientific data warehouse (CSDW). 
Key to the content layer:
- Standards
- Dedicated source by pharmaceutical company
- Providing flexibility to support variety of data sources
Business Shared Services
Supporting the users and the content is layer of business services ranging from:
- Component user support
- Compliance
- Change management
- Staging and data migrations services
- Data reconciliation
Our team will be presenting this approach at the upcoming Oracle OpenWorld conference in October. In addition to this we will also be presenting on the topic I wrote about last month – Serialization. I am very appreciative of my colleagues – specialists in a variety of topics. What I find satisfying is in ‘stitching’ all this together. We now have several interested clients and the possible next steps are to deploy this solution and that will take some time. I would be interested in hearing from you – and your comments on “Integration for RandD.”
Thanks,
Jim