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Clinical Research
Off-shoring: A Country Attractiveness Index for Clinical Trials

By Mark P. Mathieu
For many years, pharmaceutical companies have been off-shoring manufacturing operations to lower-cost countries. Healthy margins and strong risk aversion have afforded pharmaceutical companies the luxury of staying close to home, for all but manufacturing activities. As financial pressures increase, pharmaceutical executives are finding that going offshore is not only less risky than it once was, but also too attractive to ignore.  Read More



Quanticate Brings Transparency, Control to Project Management



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By Deb Borfitz

June 22, 2009 | A year ago, global biometrics clinical research organization (CRO) Quanticate began a journey to create a single electronic project management environment to manage its growing global program of work. The transition from distributed, Excel-based systems to a fully integrated, web-based Project Portfolio Management System (PPMS) is starting to “fundamentally change the way we approach projects and our relationship with sponsors,” says head of project management, Mark Campbell.

The conversion is further improving the success of projects while giving study sponsors the “transparency and control” they desire, says Campbell. While most project management systems are internal, Quanticate’s vision “surpasses the norm” by extending the use of its PPMS to customers, encouraging them to participate in the management of resources and risks within the system. Information is shared and decision making is collaborative. “Our relationship with sponsors is moving away from the traditional transactional milieu to a true partnership.”

Mark_Campbell
Mark Campbell
The enabler was Atlantic Global, whose Corporate Vision PPM software is now being used by Quanticate to conduct strategic resource planning as well as detailed management of clinical trials, such as project plans, timesheet data, and project risk.

A scalable project management system had become a must for Quanticate since its formation nearly two years ago via a merger of two 15-year-old European biometric CROs. “Quanticate heavily customized the software with Atlantic Global for the purpose of managing its roster of clinical trials, now numbering over 550.” The collaboration has significantly enhanced the software’s reporting capabilities to meet the information needs of clinical trials.

“Up until now, the software has been used out-of-the-box primarily as a strategic resource tool to support financial and manufacturing industries, including those of GSK,” says Campbell. To date, one other CRO has started using the “best practices project management” version Quanticate helped customize for clinical projects. Atlantic Global expects that number to grow, he adds.

Importantly, Campbell says, “Quanticate can now load details of a prospective project into the system to visibly demonstrate to sponsors its ability to deliver clinical trial services on time and in a fashion that gives absolute transparency to the customer.” When managing a compound through a series of projects, performance transparency creates efficiencies of scale as resources get reallocated in response to changing corporate priorities and the ebb and flow of work demands across the portfolio.

Sponsors will be able to get an anytime review of project status by this fall, when Quanticate rolls out the latest online customer dashboard enhancements to Atlantic Global’s Corporate Vision (now called Atlantic Global OnDemand) software. Status information will be provided on resource utilization, deliverables, risks, and issues, graphically presented with the ability to drill down to the underlying data. Customers will also be able to see any related project actions, add new risks and issues, or update project status.

“This enhancement will truly connect sponsors and vendor together in a way which will foster collaboration, knowledge sharing, and trust,” says Campbell, which will more reliably produce successful projects.

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See why Electronic Data Capture (EDC) is gaining traction in the pharmaceutical
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