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
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:
- 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
- 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.”
Admittedly this is not a new concept. When enterprise resource planning (ERP) was first introduced the focus was on integrating finance/accounting, manufacturing, sales and service. ERP provided the means for ‘integrating; the business processes within an organization. So why raise the topic of “ERP for R&D?” Pharmaceuticals and Medical Devices develop new products in an environment that is driven more by science than a ‘business process.’ Scientists will suggest that forcing a business process into R&D limits their creativity. Today we are well aware of the problems facing R&D: lack of new products, reduced productivity, significant capital cost with diminishing results in terms of new products.
In my last blog post “Improving the Business of RandD” the focus was on the impact that cloud computing could have on R&D. Platform as a service (PaaS) and Infrastructure as a Service (IaaS) are alternatives that can help IT supplement their existing business process. Today contract / clinical research organizations (CRO) are being used to supplement R&D in the area of clinical development. Basic research and clinical manufacturing (in some organizations) are also being ‘outsourced.’ Given this quilt of organizations and separate business processes I’ve concluded the need for “ERP for R&D.”
Ultimately change will occur. I read an interesting article “Pharmaceutical Innovation Hits the Wall: How Open Innovation Can Help” by Henry Chesbrough. He writes about the need for changes to the industry’s innovation process. You may already know about the industry’s focus on ‘blockbuster’ drugs where the business is using science to find that next billion dollar product. Which comes at the price of research in seeking medications for smaller patient populations, so I contend that the business processes with R&D need to be ‘integrated’ with visibility to the data across the organization. I do agree with the point that Henry makes in his blog post that ‘there needs to a change in the innovation process.’
I have begun this journey to offer ERP for R&D as several of my customers have asked our company to give end-to-end services. I would like to see the industry focus more on new treatment and medication innovation and leave the IT to systems integrators (SI). Unlike software development companies SIs is pretty much agnostic to the software solution and more about how to drive out cost and improve IT performance.
A lot has been written about Cloud Computing. In “Tech Giants look forward to Cloudy Days” this speaks to the competition between Apple, Google and others that want you to store your files on their technology. In “Here’s Why Cloud Computing Is So Hot Right Now” talks about the shift from client-server to ‘shared’ hardware located away from the corporate offices. In a earlier blog I wrote called “Managing my data…”I detailed my experiences with my data after my laptop was damaged. Learning to use and apply cloud computing is the focus of this blog post with an emphasis on Pharmaceuticals and Medical Devices R&D.
Lately I’ve been working in the R&D area and specifically on the business processes that extend from Basic Research through New Drug Application (NDA). Most of you have heard about the impending loss of revenue due to patent expires of branded pharmaceuticals. The question is what can be done to “Improve the Business of R&D.” For starters most companies have realized that IT is not their core business. IT is just an enabler of the business processes within a company, and most executives I know want to focus on the core business of creating new medicines and treatments. Then there is the high amount of effort needed to make sure ‘compliance’ is maintained to the local regulations, when it comes to making these products. Add to this situation if IT develops a ‘homegrown’ solutions within R&D.
In the past information technology (IT) was used to serve the needs of the R&D. Today there is a need to see how IT can accelerate the business within R&D. The example that comes to mind is how kids use technology (cell phones, laptops, tablets, etc.). They just use it to do whatever it is they are looking to do. Make it simple and the user will consume more of this technology. Today we’ve come to the conclusion that IT is not keeping up with the demands of R&D. So how can we improve this?
Cloud computing offers the ability to expand IT capacity in an ‘on demand’ fashion. We’ve begun to take this concept one step further. What if IT services providers created an infrastructure or platform ‘on demand?’ Google Mail (Gmail) is an extreme example of this where users can get access to their email through cloud computing. As more users go to Gmail capacity expands to meet the needs of the users. I say this is an extreme because the cost model for Gmail is different from a R&D model.
Imagine a day when you can ‘rent’ a process – add database capacity – replicate existing IT landscapes in the cloud. We refer to this as process-as-a-service (PaaS) where you can use any given process via the cloud. Allowing you to add new users to a business process on an as needed basis. We can also provide infrastructure-as-a-service (IaaS). We’ve had clients ask if we can offer the servers organized in a specific fashion to support their business process. Companies can leverage these services and get out o the IT business of maintaining and supporting these systems.
Is this a novel idea? Not really – other industries have enacted similar PaaS and IaaS solutions. What makes this different is that within Life Sciences (especially Pharmaceuticals and Medical Devices) you have to discuss the regulatory aspects of your IT systems. And ‘yes’ we can support a cloud computing environment that is compliant to the FDA regulations. IT services providers would have to offer this in order for Life Sciences customers to use these solutions.
What is exciting to me is that we have the opportunity to apply cloud computing for the industry and create a fully ‘integrated’ process which, I believe, will improve the business of R&D.