BioPharm Systems Unveils New Modules for Oracle’s Clinical Trial Management System

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Siebel Clinical Add-Ons Help Life Sciences Companies Stay Compliant and Boost Productivity

BioPharm Systems, a leading provider of clinical trial, data, and drug safety solutions, today announced that it has developed additional modules for its Siebel Clinical accelerator ASCEND.

First released in June 2009, ASCEND is a pre-configured and enhanced version of Oracle's clinical trial management system (CTMS) Siebel Clinical, designed to significantly reduce implementation costs and timeframes, and includes robust capabilities found on many companies' wish lists.

The new modules, available a-la-carte to life sciences companies, increase productivity through enhanced compliance and tracking capabilities:

Safety Letter Tracking: Stay in compliance – and keep your sites fully informed – with product safety letters.

  • Create safety letter records for products, and attach copies.
  • Indicate which people at which sites need to receive safety letters and when.
  • Generate lists of recipients for safety letters that automatically remove duplicates.
  • Auto-create safety letter records for sites that meet the safety letter criteria – even sites that start late.
  • See whether the appropriate product safety letters have been sent to the appropriate sites.
  • Prevent safety letter records from being regenerated or deleted after they have been sent.

Investigational Product Tracking: Know how much investigational product you have – and where you have it – at all times.

  • Set up inventory locations.
  • Create transaction records from location to location or from location to site.
  • Record quantity shipped, quantity destroyed, quantity on hold, etc.
  • Generate a report that shows drug lot, inventory accountability, and actuals at locations.

Electronic Signature: Use electronic signatures to approve trip reports.

  • When changing a trip report status, confirm that the action is intentional and correct.
  • When approving a trip report, re-enter security credentials (User ID and Password).
  • See proof of the electronic signature on the trip report.

Protocol Progress Report: Keep tabs on how your protocols are performing against their targets.

  • Enter key metrics and performance indicators for each protocol.
  • Generate a Protocol Progress Report for upper management as often as necessary.

“These new modules are based on the same concept as ASCEND; each module comes pre-configured to meet most companies’ requirements out-of-the-box and they can be implemented for a fraction of the time and cost,” said Parambir Singh, vice president of clinical trial management solutions, BioPharm Systems. “While these modules are designed to be used with ASCEND, we can also work with organizations to incorporate and implement them for their custom Siebel Clinical systems.”

Additional information and webinars on ASCEND can be accessed by visiting http://www.biopharm.com/products/ascend.aspx.

BioPharm Systems is an Oracle Accelerate partner and a Gold member in Oracle PartnerNetwork.

About Oracle Accelerate

Oracle Accelerate is Oracle’s approach to provide rapid implementation business software solutions to midsize organizations. Oracle Accelerate solutions include Oracle’s enterprise-class software delivered with business accelerators by expert implementers. Business accelerators are rapid implementation tools, templates and industry- and geography-specific leading practice process flows to help dramatically reduce implementation time, complexity, cost and risk. To find out more, visit http://www.oracle.com/accelerate.

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 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 http://www.oracle.com/partners.

About BioPharm Systems

BioPharm Systems (http://www.biopharm.com) is an IT consulting company that focuses on the life sciences industry. We have extensive experience in the implementation, integration, migration, and hosting of Oracle's clinical trial management (Siebel Clinical), drug safety and pharmacovigilance (Argus Safety and Adverse Event Reporting System), clinical data warehousing and analytics (Life Sciences Data Hub and Clinical Development Analytics), clinical data management (Oracle Clinical), and electronic data capture (Remote Data Capture) systems. Our products and services help accelerate the development of new drugs, devices, and other therapies.

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 or e-mail info(at)biopharm(dot)com.

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North America Sales Contact:
Rod Roderick
rroderick(at)biopharm(dot)com
+1 877 654 0033

Europe/Middle East/Africa Sales Contact:
Adrian Hampshire
ahampshire(at)biopharm(dot)com
+44 (0) 1865 910200

Communications Contact:
Eugene Sefanov
esefanov(at)biopharm(dot)com
+1 617 795 2032

Twitter: http://www.twitter.com/BioPharmSystems
Facebook: http://www.facebook.com/BioPharmSystems
LinkedIn: http://www.linkedin.com/companies/biopharm-systems-inc
YouTube: http://www.youtube.com/user/BioPharmSystems

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