Can “Clinical Data Integration on the Cloud” be a reality?

The story I am about to tell is almost 8 years old. I was managing software services delivery for a global pharmaceutical company from India. This was a very strategic account and the breadth of services covered diverse systems and geographies. It is very common that staff from the customer organization visit our delivery centers (offsite locations) to perform process audits, governance reviews and to meet people in their extended organizations.

During one such visit a senior executive noticed that two of my colleagues, sitting next to each other, supported their system (two different implementations of the same software) across two different geographies. They happened to have the name of the systems they support, pinned to a board at their desks. The executive wanted us to take a picture of the two cubicles and email to him. We were quite surprised at the request. Before moving on to speak to other people he asked a couple of questions and realized the guys were sharing each other’s experiences and leveraging the lessons learnt from one deployment for the other geography.  It turned out that this does not happen in their organization, in fact their internal teams hardly communicate as they are part of different business units and geographies.

The story demonstrates how these organizations could become siloes due to distributed, outsourced and localized teams. Information Integration has become the way of life to connect numerous silos that are created in the process. Clinical research is a complex world.  While the players are limited, depending on the size of the organization and the distributed nature of the teams (including third parties), information silos and with that the complexity of integration of data increases. The result is very long cycle times from data “Capture” to “Submission”.

Clinical Data Integration Challenges

The challenges in integrating the clinical data sources are many. I will try to highlight some of the key ones here:

  • Study Data is Unique: depending on the complexity of the protocol, the design of the study, the data collected varies. This makes it difficult to create a standardized integration of data coming in from multiple sources.
  • Semantic Context: while the data collected could be similar, unless the context is understood, it is very hard to integrate the data, meaningfully. Hence, the integration process becomes complex as the semantics become a major part of the integration process.
  • Regulations and Compliance: Given the risks associated with clinical research, it is assumed that every phase of the data life should be auditable. This makes it very difficult to manage some of the integrations as it may involve complex transformations along the way.
  • Disparate Systems: IT systems used by sponsors, CROs and other parties could be different. This calls for extensive integration exercise, leading to large projects and in turn huge budgets.
  • Diverse Systems: IT systems used at each phase of the clinical data life cycle are different. This makes sense as the systems are usually meant to fulfill a specific business need. Even the functional organizations within a business unit will be organized to focus on a specific area of expertise. More often than not, these systems could be a combination of home grown and commercial off the shelf products from multiple vendors. Hence, the complexity of integrations increases.

What is Integration on the Cloud?

As mentioned earlier, integration is a complex process. As the cloud adoption increases, the data may be distributed across Public, Private (Includes On-Premise applications) and Hybrid clouds. The primary objective of integration on the cloud is to provide a software-as-a-service on the cloud to integrate diverse systems. This follows the same pattern as any other cloud services and delivers similar set of benefits as other cloud offerings.

The “Integration on Cloud” vendors typically offer three types of services:

  1. Out-of-Box Integrations: The vendor has pre-built some point-to-point integrations between some of the most used enterprise software systems in the market (like ERPs, CRMS etc.)
  2. Do-it-Yourself: The users have the freedom to design, build and operate their own integration process and orchestrations. The service provider may provide some professional services to support the users during the process.
  3. Managed Services: the vendor provides end-to-end development and support services

From a system design and architecture perspective, the vendors typically provide a web application to define the integration touch points and orchestrate the workflow that mimics a typical Extract-Transform-Load (ETL) process. It will have all the necessary plumbing required to ensure that the process defined is successfully executed.

Who are the players?

I thought it would be useful to look at some of the early movers in this space. The following is a list (not exhaustive and in no particular order, of course) of “Integration on Cloud” providers:

  1. Dell Boomi : Atom Sphere
  2. Informatica : Informatica CLOUD
  3. IBM : Cast Iron Cloud Integration
  4. Jitterbit : Enterprise Cloud Edition

These vendors have specific solution and service offerings. Most of them provide some out-of-the-box point-to-point integration of enterprise applications like ERPs, CRMs etc. They also offer custom integrations to accomplish data migration, data synchronization, data replication etc. One key aspect to look for is “Standards based Integration”. I will explain why that is important from a clinical data integration perspective later. While this offering is still in its infancy, there are some customers that use these services and some that are in the process of setting up some more.

Clinical Data Integration on Cloud

Many of you dealing with Clinical Data Integration may be wondering as to “Why bother with Integration on the Cloud?” while we have enough troubles in finding a viable solution in a much simpler environment. I have been either trying to create solutions and services to meet this requirement or trying to sell partner solutions to meet this requirement for the past 4 years. I will confess that it has been a challenge, not just for me but for the customers too. There are many reasons like, need to streamline the Clinical Data Life Cycle, Data Management Processes, retiring existing systems, bringing in new systems, organizational change etc. Not to mention the cost associated with it.

So, why do we need integration on the cloud? I firmly believe that if a solution provides the features and benefits listed below, the customers will be more than willing to give it a strong consideration (“If you build it, they will come”). As with all useful ideas in the past, this too will be adopted. So, what are the features that would make Clinical Data Integration on the cloud palatable?  The following are a few, but key ones:

  1. Configurable: Uniqueness of the studies makes every new data set coming in from partners unique. The semantics is also one of the key to integration. Hence, a system that makes it easier to configure the integrations, for literally every study, will be required.
  2. Standards: The key to solving integration problems (across systems or organizations), is reliance on standards. The standards proposed, and widely accepted by the industry (by bodies like CDISC, HL7 etc.) will reduce the complexity. Hence, the messaging across the touch points for integration on the cloud should rely heavily on standards.
  3. Regulatory Compliance and GCP: As highlighted earlier, Clinical Research is a highly regulated environment. Hence, compliance with regulations like 21 CFR Part 11 as well as adherence to Good Clinical Practices is a mandatory requirement.
  4. Authentication and Information Security: This would be one of key concerns from all the parties involved. Any compromise on this would not only mean loss of billions of dollars but also adverse impact on patients that could potentially benefit from the product being developed. Even PII data could be compromised, which will not be unacceptable
  5. Cost: Given the economically lean period for the pharma industry due to patent expiries and macro-economic situation, this would be a key factor in the decision making process. While the cloud service will inherently convert CapEx to OpEx and thus makes it more predictable, there will be pressure to keep the costs low for add-on services like “new study data” integration.

Conclusion

All in all, I would say that it is possible, technically and economically and also a step in the right direction to overcome some existing challenges. Will it happen tomorrow or in the next 1 year? My answer would be NO. In 2 to 3 years, probably YES. The key to making it happen is to try it on the cloud rather than on-premise. Some of the vendors offering Integration on Cloud could be made partners and solve this age old problem.

Update on 03/27/2012:

This post has been picked up by “Applied Clinical Trials Online” Magazine and posted on their blog -> here

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About Venu Mallarapu

I am currently working as Associate Director at Cognizant Technology Services in their Life Sciences division. I have over 15 years of experience in developing IT Solutions and Services, specifically for Life Sciences industry for about 9 years. I have worked with small to large pharma customers to address various business requirements in R&D, Sales and Marketing areas. IT Service Management is one of my other passions. I blog and write about technology frequently and have also presented at various conferences and workshops on wide variety of topics in technology.

8 responses to “Can “Clinical Data Integration on the Cloud” be a reality?”

  1. Namrata says :

    This is a very wonderful article on insite of Clinical research merging with IT sphere to speed up the process on one platform ‘Cloud’.

  2. Jon Barton says :

    This is a great article and a prime example of the kind of idealistic thinking that a few years in the pharmaceutical industry will cure forever :) You mention – almost as an aside – regulatory compliance, good clinical practice and security. The only industry that is more tightly regulated than the pharmaceutical industry is the aeronautical industry. Pharmaceutical regulations are insanely tight and for good reason – get it wrong and people die. So adherence to GCP is not even something that needs to be discussed – any solution not using GCP would be laughed out of the boardroom. Information security – or rather lack of a closed auditable system – could be the difference between marketing authorisation and several billion dollars down the drain. Unless you can show a regulatory inspector where every single bit of confidential data resides and prove its security you don’t have an auditable system. Certainly in pharmacovigilance, system compliance is part and parcel of the pv system as a whole. One of the key benefits of cloud is that you don’t need to know where the data is specifically – it is on the cloud and that is sufficient for cloud. It wouldn’t be sufficient for regulators. So in reality you’re looking, at best, at a “private cloud” – clusters of relatively inexpensive hot-swappable virtualised hardware that can be ramped up (or down) as required. The Sun “data centre in a shipping container” solution (I know Dell are doing these as well and HP too I think). That could have key benefits over a traditional data centre in terms of running costs / overheads. It’s not exactly a cloud in the Google / Amazon sense but pharmaceutical computing is so specialised in terms of security requirements that one of these “general” solutions is unlikely to be suitable anyway.

    The main issue is that the pharmaceutical industry is not a bleeding edge technology user – it can’t be. The industry as a whole is risk-averse by nature so any exciting, cutting edge solutions usually have to endure years of testing and trialling before eventually being rolled out just before they hit obsoletion. It’s a tough situation – the other option would be to make it illegal to sue pharmaceutical companies when tech goes wrong and that would never be acceptable.

    • Venu Mallarapu says :

      Thanks Jon, for your insights. I think they are realistic and true to a large extent. I’ve been around in the pharmaceutical industry enough to understand the impact and travails of organizations that doesn’t adhere to the regulatory compliance and what that means to patient population. I have lived through one such nightmare a large pharma went through by putting a drug out there that is risky and potentially cost people lives. This is an industry that is not in the bleeding edge of technology is an understatement in the least. However, I have seen organizations drowning themselves in documentation hell in the name of regulatory compliance. This is definitely a significant contributor to the overall cost of manufacturing the drugs. At the same time some of it is definitely necessary to ensure that everything is done in a manner that can be audited and reviewed.

      One thing I have seen though is that there are more and more organizations that are looking at new technology to solve some of their problems. I think leveraging the cloud, in whatever form it is, will definitely help them reach this goal. We are seeing organizations that are willing put all their emails out there on the cloud (http://www.microsoft.com/casestudies/case_study_detail.aspx?casestudyid=4000005460) which would have been unimaginable a decade ago. So, unless some people enter into untested waters and test them out, there will be no innovation. There are healthcare organizations that are using data integration on the cloud already and that is an industry that is regulated.

      In essence, while your observations and thoughts are more realistic and mine are a bit more idealistic, this is a phenomenon that is starting and I am confident that we will see and hear about some pretty soon.

  3. Rebecca Griffiths says :

    Great article! I wanted to just post a link to our company: http://basecase.com/ We have developed web-based apps that transform complex health economic data into interactive tools. I would love to hear your feedback on the product. You can contact me on r.griffiths@basecase.com.

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