How To...Accelerate Time to Value When Deploying Clinical Trial Management

Guest Post by Param Singh, VP of Clinical Trial Management Solutions, BioPharm Systems

BioPharm Systems, a Gold level partner in Oracle PartnerNetwork, joined the Oracle Accelerate Program in 2011 with an Oracle Accelerate Solution Based on Oracle’s Siebel Clinical Trial Management System.


Accelerating a Multi-Faceted Clinical Trial Management System Implementation Project

There are several ways to speed up a clinical trial management system (CTMS) implementation, including choosing an accelerator and having it hosted in the cloud. Both of these concepts have existed for a few years and have gained a lot of traction. Organizations that opt for accelerators in the cloud have learned that it gives them a big leg up on the competition.

Now, there is another way to speed things up. It is a project management approach called “Rolling Releases.” MannKind Corporation (MannKind) completed an implementation in July of Siebel Clinical, Oracle’s CTMS that involved an accelerator, the cloud, and rolling releases. Read on to learn more about their thought process and experience with employing all three accelerator methods together.

Given the anticipated success of MannKind’s innovative insulin therapy called AFREZZA and plans for research into additional applications of their therapeutic approach, the company recognized the need to replace their existing CTMS with a more comprehensive, user-friendly CTMS, particularly one with advanced site payment functionality and the ability to integrate with their clinical data management and electronic data capture (EDC) systems, Oracle Clinical / Remote Data Capture (OC/RDC). Based on their planned clinical trial schedule, they knew they needed a solution in place quickly, despite knowing that implementations involving integrations generally take a long time. The organization also knew they did not have the necessary information technology resources to implement and maintain a system in-house, so they needed a CTMS in the cloud.

Planning With a Tight Timeline

MannKind selected BioPharm Systems’ pre-configured version of Oracle’s Siebel Clinical solution, ASCEND, part of the Oracle Accelerate program. Although the CTMS accelerator met most of their requirements out-of-the-box, the remaining requirements revolved around a collection of intelligent site payment enhancements and the integration with OC/RDC. Due to MannKind’s tight timeline, BioPharm proposed an innovative approach to the project that involved “rolling releases,” meaning that the work would be divided into separate, logical work streams that could be executed largely in parallel, thus significantly shortening the overall project timeline. In addition, BioPharm proposed that one of those work streams be the implementation and release of the base version of ASCEND, so that MannKind could begin benefiting from their new system while the other work streams were still in progress. MannKind’s custom and integrated system would also be hosted and managed by BioPharm in a private cloud.

A Three Pronged Parallel Approach

The project was divided into three work streams:

  1. Implementation of the base version of ASCEND
  2. Application changes
  3. EDC integration
The project began with the parallel installation of the development (Dev) and production (Prod) environments of the base version of ASCEND. While the computer systems validation activities were being conducted for Prod, the application changes and integration coding began in Dev. Once Prod was validated, BioPharm cloned the environment to create the validation (Val) environment to be used for testing the additional work streams. When Prod and Val were fully validated, BioPharm trained MannKind and Prod was released for use. MannKind began using the system right away, entering clinical administration data, as well as building their investigator database.

Ahead of Schedule

Just six weeks later, the application changes were validated and released to Prod for use. This work stream was released nearly three weeks ahead of schedule, allowing MannKind to expand their data entry to include study, country, and site-specific information even sooner than planned.

Just four weeks after the application changes went live, the EDC integration work stream was validated and released to Prod for use. This work stream was also completed nearly three weeks early, providing MannKind with all three work streams in just three months; all validated, all integrated with Active Directory, and all hosted and managed by BioPharm in a private cloud.

Time = Money

BioPharm’s approach to the CTMS implementation and integration at MannKind resulted in:

  1. An estimated time savings of 3-4 months per work stream
  2. Quicker return on investment (ROI)
  3. Increased user adoption, due to receiving the system sooner and learning to use it in smaller chunks
  4. Long-term cost savings due to private cloud hosting services

In this fast-paced industry in which so much depends on being first-to-market, we expect to see more time-saving innovations around CTMS and other system implementations. Accelerators, hosting and, now, rolling releases. We are excited to see what comes next.

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