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Risk based monitoring and SDV – Increased adoption of ECM

It is universal fact that the escalating costs of discovering new medicinal products are driving sponsors and CROs to scrutinize every dollar spent in the process. The situation is escalating fast as pressure mounts with the blockbusters of yester years come off patents. This means that there is a need for all the stakeholders in the value chain to revisit their approach to existing processes and come up with innovative ways to save costs.

Key Trends:

Risk Based Site Monitoring:

US FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”. As per the document its overarching goal is to “enhance human subject protection and the quality of clinical trial data”. However, it clarifies on the strict interpretation that the industry has assumed long back and has spent billions in monitoring the sites. While this is draft guidance it is more than likely that this will end up in establishing the guiding principles for central monitoring of clinical trials, as such is the intent.

Risk Based Source Document Verification:

Primary activity of site monitoring is the source document verification and as was the case in site monitoring, industry has been mostly using the strict interpretation of source document verification. This resulted in 100% of source documents (patient eCRFs) being verified by the site monitors. However, the industry has realized that “law of diminishing returns” applies to this process as well and has been reducing the percentage of documents verified by the monitors. Medidata’s Insights “Targeted Site Monitoring Trend Snapshot” published in Applied Clinical Trials website confirms this trend.  According to this report the SDV percentage has reduced from 85% in 2007 to 67% in 2010.

Virtual Clinical Trials:

Another key trend that is slowly evolving in this context is complete virtualization of clinical trials. Pfizer is taking the lead in this space. While Pfizer’s REMOTE program is ongoing, an interim feedback from the program is provided by Mr. Craig Lipset, Head of Clinical Innovation at Pfizer is provided by Applied Clinical Trials in their article titled “Pfizer’s REMOTE Virtual Experience”. As highlighted in the article, they are going through the roadblocks of an early adopter.

Adoption of Enterprise Collaboration and Content Management:

Electronic communication and collaboration:

The above trends indicate that it is just a matter of time that total virtualization of clinical trials is accomplished. The key question that needs to be addressed is “How will the human interactions be virtualized?” The answer is “to adopt electronic communication and collaboration channels”. The channels can range from adopting systems to capture and manage clinical data, electronic source document verification to seamless communication and collaboration tools. The unique constraint with respect to clinical trials though is to ensure that the tools used adhere to “Good Clinical Practices” as well as other regulatory requirements like 21 CFR Part 11, HIPAA etc.

Enterprise Collaboration and Content Management Systems:

Systems for Electronic data capture (EDC), Clinical Data Management (CDM), Clinical Trial Management System (CTM), Adverse Event Management etc. are already available in the market. The key tool that would make it easier to seamlessly transition from human interactions to virtual interactions, in my view, is an Enterprise Collaboration and Content Management tool. Tools like Microsoft’s SharePoint, as highlighted in one of my previous blog posts, will help organizations make this transition fast and cost-effective. While it is always easier said than done, from real world experiences that we already have, it is relatively easy to adopt these tools in a GxP environment, meet all the regulatory compliance requirements and also accomplish the degree of flexibility required to easily communicate and collaborate.

Social Media and Mobility:

A couple more initiatives that could complement in the process are Social Media and Mobility. The need for a social media outreach program to increase the patient recruitment is highlighted by the channels Pfizer’s REMOTE program has adopted.  On similar lines, social media “like” features can be enabled on the collaboration and communication platform to be adopted. This can increase the accessibility and improve the response times from the patients. On similar lines, if the collaboration and communication platform can be made available over mobile devices like smart phones, tablets etc. the patient compliance and response times will improve considerably. Tools like Microsoft SharePoint make it easy to enable the social features and also deliver content to mobile devices.

Conclusion

Overall the ability of a sponsor or CRO organization increases tremendously to virtualize their clinical trial process by leveraging collaboration and content management tools. The overall “Risk-Based” approach to site monitoring and source document verification will also be “made easy” through these tools.  As noted in my previous posts, leveraging a tool like SharePoint for such purpose will improve the Return on Investment (ROI) and reduce the Total Cost of Ownership (TCO) of these tools.

As always, your feedback and comments are welcome.

Update, 20-Mar-2012:

This post has been picked up by www.AppliedClinicalTrialsOnline.com and published on their website.

Jumpstart your PV Operational Efficiency Improvement Initiatives through Oracle Pharmacovigilance Operational Analytics (OPVA)

I attended Oracle Open World (OOW) recently during the week of Oct 2nd. I got a sneak peek of the newly released Oracle Pharmacovigilance Operational Analytics tool. This tool is intended to provide a jumpstart to the efforts of Safety & Pharmacovigilance departments of MAHs and CROs in being able to monitor the operational performance of the organizations and identify the bottlenecks. The key point to note is that this tool provides only the Operational Analytics and doesn’t include the Scientific Analytics.

Some of the Key business benefits it will deliver include:

  • Insights into the case processing operations
  • Measure compliance and productivity across the organization
  • Provide ability to monitor the KPIs and metrics through dashboards in real time
  • Provide ability to drill down to identify the bottlenecks in the process
  • Improve productivity and save costs across the organization
  • Improve compliance and enable better patient safety

From IT Systems perspective:

  • Single repository of operational safety data
  • Star schemas that could be populated with data from internal and external sources
  • Predefined reports, KPIs, Metrics and Dashboards
  • Ability to customize and extend the dashboards and reports
  • Ability to view current as well as historical operational performance of organization and individuals
  • Out-of-the-box integration with Oracle’s Argus Safety
  • Built using Oracle BI (OBIEE) which gives ability to view dashboards on web as well as on mobile devices (iPhones and iPads)

Some of the key dashboards that are provided out-of-the-box:

  • Case processing history in terms of volumes, compliance and repetition
  • Case processing management in terms of volumes, compliance and workflow state SLA management
  • Personal user dashboards with individual’s case management and case history,

Some of the reports include:

  • Completed case volume overview and trends
  • Pending case volume overview and trends
  • Case version line listings
  • Individual case workload reports and line listings

OPVA is compatible with Argus Safety 6.0.2 and Argus Safety 7.0.

One of the key uses of OPVA for organizations that want to define additional metrics, KPIs, dashboards and reports is the start schema that is provided with the product. It comes with a set of predefined dimensions and facts that can be leveraged to speed up the process of developing the additional custom dashboards, KPIs, Metrics and Reports.

Dimensions provided by the OPVA schema are:

  • Period
  • Product
  • Study
  • List of Values
  • Users
  • User Group
  • Case Processing Site
  • Country
  • Enterprise (in a multi-tenant scenario more relevant for CROs)

The pre-built facts into the OPVA data mart are:

  • Case Version History
  • Case Routing History
  • Case Workflow History and
  • Pending Cases

I think this is a very good addition by Oracle to its stable of products and compliments the existing tools quite well. This is also a very good tool for customers wanting to jumpstart their efforts to measuring their safety operations (aka Case Processing), identifying the bottlenecks in terms of compliance and productivity and rein in costs through improvement plans to enhance these aspects.

Oracle launches Argus Safety 7.0…

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.

Oracle Argus 7.0

Oracle's Argus 7.0 CRO/TSP Setup

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.

Changing role of CROs in Clinical Trials

Research Outsourcing:

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.

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