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:
- 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.)
- 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.
- 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:
- Dell Boomi : Atom Sphere
- Informatica : Informatica CLOUD
- IBM : Cast Iron Cloud Integration
- 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:
- 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.
- 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.
- 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.
- 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
- 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.
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
Oracle released their latest version of Argus Safety Suite 7.0. The biggest highlight of this release is the “Multi-Tenancy”. This comes very handy for organizations that manage patient safety on behalf of more than one sponsor. This is being dubbed as a ‘CRO Release‘ for obvious reasons. However, another set of service providers that could benefit from this is the Technology Service Providers (TSPs).
Leveraging Argus 7.0, CRO and TSP organizations can host one instance of the application (not considering the various development, test, validation, training environments required) and provide technology and functional services to multiple organizations. The software comes with all bells and whistles required for it to be regulatory compliant as well as keeps the data clean so there is no compromise of patient information and critical safety information. The biggest advantage is the feature set that will enable the CRO/TSP organizations manage the configuration required for each organization separate but at the same time enable them to be able to jump start a new organization’s configuration by leveraging configuration settings of an existing organization.
The diagram depicts a simplistic view of how this works. Please note that it does not include all the components of Argus system as well as the network elements required to ensure connectivity between the CRO/TSP to the sponsor organization. Essentially multiple sponsors will be able to connect to the Argus application through a custom/standard portal setup by the CRO/TSP.
In case of CROs, their internal staff viz. Admins, Data Entry, QA, and Medical Review personnel (depending on requested workflow by the sponsor or the CROs SOPs) would manage the cases. In case of TSPs, the Implementation (installation, configuration and support) and Hosting services could be provided by them while the sponsor manages the case processing bit.
Other enhancements to Argus Insight, Argus J and another new tool to manage Operational Analytics are slated for release throughout this year. In terms of upgrades, it comes with provision to upgrade from 6.0 and 6.0.1. However, for customers on prior versions, they would have to follow the step-by-step upgrade path till version 6 and then upgrade to 7.0.
If you need more details please write to me.
Just like the Pharmaceutical and Biotech companies are realizing that IT services is a non-core activity that they tend to focus on due to growth of IT departments over a period of time. In this era of “Virtualized Everything”, outsourcing has become a common theme in IT for these organizations. Having said that, they typically outsource their R&D operations to specialized organizations like CROs.
IT Outsourcing by CROs:
CROs tend to provide mostly drug development activities, which include initiating and monitoring the clinical trials as well as providing the necessary IT backbone to manage data and documents created as part of this process. Because of renewed focus on core competencies, more and more CROs are looking for partners to outsource their IT systems and services. As a result of this, a new trend is emerging where in there would be two categories of CROs, Functional Service Providers (FSP) and Technology Service Providers (TSP).
Technically speaking, TSPs are not really CROs as they are not providing any clinical research services, however they are enabling the FSPs by providing the technology services required. The difference between your typical IT service provider and the TSP is that the TSPs should understand the Life Sciences domain. The primary reason for this is the regulatory compliance that is demanded by the Life Sciences industry in general.
Typical TSP Services:
So, what solutions and services do these TSPs provide? I think the following are some of the solutions and services these organizations can provide:
1. Technology Consulting
2. Tool Implementation and Support
3. Upgrades, Migrations & Integrations
4. Hosting Services
5. Computer System Validation
While the above mentioned services cuts across multiple areas within the clinical trial process, the question arises as to why would these organizations require domain knowledge?
Some additional functions that these teams can perform are:
1. Study setup in Clinical Data Management Systems and Clinical Trial Management Systems
2. Clinical Data Aggregation & Analytics
3. Safety & Pharmacovigilance System Setup
While the above mentioned are some high level activities, there would be always some grey areas where one would questions as to whether a specific service falls under a FSP or a TSP. For example, if you take designing CRFs, ideally you would want an FSP personnel to design these as they would understand the protocol easily and be able to translate that easily into the form design. Having said that, the CRFs also require some programming skills in which case you would need a TSP personnel. This is one of the ways a TSP differentiates from a regulat IT Service Provider.