MannKind Corporation Implements BioPharm Systems’ Siebel Clinical Trial Management System Accelerator to Support Growing Product Pipeline

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Cloud-based CTMS Will Help Biopharmaceutical Company Streamline Clinical Operations

MannKind Corporation has implemented BioPharm Systems’ ASCEND, a pre-configured and enhanced version of Oracle’s Siebel Clinical Trial Management System (CTMS), to support its growing biopharmaceutical product pipeline. ASCEND is replacing MannKind’s existing commercial CTMS, which no longer meets the needs of their clinical operations team. In addition to choosing ASCEND, MannKind also elected to leverage BioPharm’s cloud hosting platform and managed services in order to reduce costs and save time.

In addition to the implementation of the base version of ASCEND, MannKind has identified a set of custom configurations, as well as integrations with their electronic data capture (EDC) systems, Oracle Clinical (OC) and Remote Data Capture (RDC), to be included in their first release of ASCEND. Despite these complexities, BioPharm is providing MannKind with a quick return on investment (ROI) by managing the project with its "rolling release" approach, in which each of the work streams are executed in parallel, yet still under validation control. This innovative strategy is enabling MannKind to begin benefiting from ASCEND before all of the work streams have been completed.

One of the key areas of ASCEND that MannKind has chosen to customize is the site payments process. Prior to ASCEND, MannKind managed all site payments manually, including complexities like withholding percentages, site advances, and overhead costs. Working together, MannKind and BioPharm have designed a solution that makes use of Siebel Clinical’s existing functionality plus a few intelligent enhancements, resulting in a system that supports a fully automated site payments process.

"I’ve managed many Siebel Clinical and ASCEND implementations over the years, and I have to commend MannKind on their approach to this project," said Param Singh, vice president of clinical trial management solutions, BioPharm Systems. "So many companies try to over-engineer their CTMS solutions, but MannKind really saw the value in a pre-configured accelerator and opted not to reinvent the wheel, but rather to take full advantage of the best practices built into ASCEND, with just a handful of thoughtful customizations."

BioPharm is a Gold level member of Oracle PartnerNetwork (OPN) and an Oracle Accelerate solution provider. The company has achieved Specializations in Oracle Argus Safety Suite, Oracle Life Sciences Data Hub, and Oracle Accelerate for Midsize Companies.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. Its lead product candidate, AFREZZA®, is in late stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia.

About Oracle PartnerNetwork

Oracle PartnerNetwork (OPN) Specialized is the latest version of Oracle's partner program that provides partners with tools to better develop, sell and implement Oracle solutions. OPN Specialized offers resources to train and support specialized knowledge of Oracle products and solutions and has evolved to recognize Oracle's growing product portfolio, partner base and business opportunity. Key to the latest enhancements to OPN is the ability for partners to differentiate through Specializations. Specializations are achieved through competency development, business results, expertise, and proven success. To find out more, visit

About Oracle Accelerate

Oracle Accelerate provides simple to deploy, packaged, enterprise-class software solutions to growing midsize organizations through Oracle’s network of expert partners. Oracle Accelerate solutions enable growing midsize organizations to easily adopt Oracle's enterprise class software. Created by Oracle's expert partners, Oracle Accelerate solutions are simple to deploy, industry-specific packaged solutions, designed for fast time to benefit, which means getting the right solution in place quickly, inexpensively with a controlled scope and predictable returns. The best Oracle Accelerate Solutions are based on Oracle Business Accelerators, which are advanced implementation tools, created and maintained by Oracle. To find out more, visit

About BioPharm Systems

BioPharm Systems ( is a global IT consulting and managed services provider (MSP) that focuses on the life sciences industry. We have extensive experience in the implementation, integration, migration, upgrade, and hosting of the following Oracle clinical trial management, drug safety and pharmacovigilance, clinical data warehousing and analytics, clinical data management, and electronic data capture systems: Siebel Clinical, LabPas, Argus Safety Suite (Argus Safety, Argus Safety Japan, Affiliate, Interchange, Reconciliation, Dossier, Insight, and Perceptive), Adverse Event Reporting System (AERS), Empirica Signal, Empirica Topics, Life Sciences Data Hub (LSH), Clinical Development Analytics (CDA), Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS).

Founded in 1995 and headquartered in California, BioPharm Systems has offices in the United States and the United Kingdom. To learn more about the company's products and services, please call +1 877 654 0033 (U.S.), +44 (0) 1865 910200 (U.K.), or e-mail info(at)biopharm(dot)com.


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Vice President of Sales, Trial Management Solutions
+1 877 654 0033

Vicky Green
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+1 877 654 0033

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+44 (0) 1865 910200

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