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TrialStat® (a technology arm of Jubilant Clinsys) is a leading provider of on demand EDC solutions which empower clinical research professionals to collect and manage clinical data nearly twice as fast as the industry average using innovative, easy to use configurable and flexible features through a secure browser interface released TrialStat Orbit v 5 the latest offering from the TrialStat eClinical Suite of products. TrialStat Orbit has been successfully deployed at global locations in over 300 studies in a variety of therapeutic areas.

The latest version of TrialStat Orbit offers two main new features:

  • An enhanced data validation tool that provides real-time and post data validation
  • Subject Login Portal enabling 100% data collection accuracy with subject reported data

The new enhanced data validation tool enables TrialStat®'s global development team to produce an array of validation scenarios not previously available. The new version reduces timelines by performing real-time data cleaning, automatic triggering of Data Clarification Forms (DCFs), and automated e-mail alerts to users notifying them of a DCF action required, without users having to login to the application.

The new Subject Login Portal ensures robust capture of information input directly by study subjects which helps enrollment, retention and improves the quality of reported data for Phase IV studies. The dynamic data cleaning functionality ensures cleaner subject reported information. Additionally, the Subject Portal offers multiple languages configurable by project, customized login portal link, an easy-to-use interface, custom windows for data collection accuracy, form logic capabilities, full reporting and exporting of data.


Center Watch Weekly Interview: Nayan Nanavati, CEO, Jubilant Clinsys
CWWeekly's semi-monthly company profile feature, Insider Insights, interviews executives of companies and organizations in the clinical trials space. Writer Ronald Rosenberg sat down with Nayan Nanavati, chief executive officer of Jubilant Clinsys.

CROs

Contract research organizations (CROs) are helping biopharma and medical device companies speed time-to-market and lower overall costs for new products and treatments. CROs are increasingly looking to strategic partners to further accelerate study time and more efficiently manage operational costs.

That's why they are turning to TrialStat and its CROFirst Program. In conjunction with TrialStat Orbit, the program is designed to enhance CROs' ability to deploy and manage their sponsors' studies quickly and cost-effectively. With CROFirst, CROs can quickly deploy TrialStat's TrialStat Orbit and bolster their business development activities through jointly administered sales and marketing.

Already, TrialStat® has partnered with some of the industry's fastest growing CROs, providing complete clinical data solutions on demand offering to manage sponsors' studies regardless of therapeutic area or phase. Whether in Europe, North America or Asia, TrialStat® is helping CROs grow their business and improve the way they collect and manage clinical data. As a result, CROs have a trusted partnership with TrialStat® and a highly differential service offering that they can customize for their sponsors.

Strategic Partners

TrialStat® works with a diverse range of strategic partners that supplement and enhance our products and services. With these partners, we provide our customers with a modular ecosystem from which they can select best-of-breed Web-based solutions that are integrated into the TrialStat eClinical Suite. This integrated on demand approach supports our customers' unique clinical research environments and accelerates time-to-market.

Best Practices for CROs Planning to Use EDC

Introduction
With patents expiring more rapidly, fewer blockbuster drugs and escalating costs for clinical trials, biopharma sponsors need CROs to demonstrate their research and business value. Whether it's accelerated time-to-market with adaptive trials, or reducing time-to-know with cleaner data, CROs are being asked to deliver solution sets that can assist sponsors in bringing new compounds to market more cost-effectively, quickly and safely.

Why SaaS?

IDC, an industry research firm, defines Software-as-a-Service (SaaS) or on demand software as having the following characteristics:

  • Web-based access to and management of software sold on a subscription basis
  • Software managed from a central data center
  • Software used by multiple users through a Web browser
  • Centralized product updates

Gartner predicts that 25% of all software will be delivered on demand by 2011. IDC, meanwhile, estimates that the SaaS market will represent a compound annual growth rate (CAGR) of 32.2%, totaling $14.8 billion in revenue by 2011.

So why SaaS for clinical research?

Gartner Research says that companies can spend more than 75% of their IT budget on maintaining their traditional software infrastructure. Hidden personnel costs, such as help desk, deployment maintenance and 24x7 managed operations, are significant contributors to increased operational expenses.

Having front-end loaded IT investments represents a disproportionate expense per trial, particularly with high failure rates. Why invest $1.2 million upfront for an EDC solution to support a Phase III trial with a 45% failure rate? Why not identify the efficacy of the studied drug compound early and assess the merits of either continuing or discontinuing the use of your EDC solution?

That's what SaaS enables you to do; It benefits clinical research, then, in the following ways:

  • Faster more cost-effective deployment times. All your organization needs is access to a Web browser
  • SaaS can be an operational expense for R&D departments, either on a project or enterprise basis to better manage personnel and research costs
  • Configurable design tools allow for greater customization of study designs and workflows
  • A subscription pricing model allows you to assess whether to continue or discontinue using EDC based on a trial's results
  • The SaaS vendor is responsible for maintenance and security, enabling your IT department to focus on creating value through the innovative application of new technologies.

EDC On Demand

The business argument for EDC is well documented: Reduce your cost per page of data by as much as 80%; Lower overall clinical trial operating expenses by as much as 50%. In short, make better decisions sooner and more cost-effectively.

But that's only half the equation. EDC must also meet the changing dynamics of an industry looking at new approaches to clinical trials and drug development. Adaptive clinical trial designs, for example, are increasingly considered a viable alternative to the standard way studies are conducted. To manage adaptive clinical trials, however, requires robust statistical applications and a real-time EDC environment. Targeted or customized treatment solutions (TTSs) also require a technology infrastructure that can scale and manage a full range of complex analytical applications. And internationally-administered clinical trials further heighten the need for data standards, such as those advocated by CDISC.

Orbit delivers better study results faster, meets the business imperatives of lower operating costs and supports emerging ways to start and conduct studies. As the industry's first browser configurable on demand EDC solution, Orbit enables you to flexibly create and manage different studies regardless of phase or therapeutic area. And because it's on demand, requiring only a Web browser to enter and manage data, Orbit lets you deploy your studies twice as fast as more conventional EDC solutions, while readily scaling for globally managed trials and enterprise-wide deployments. Here's why:

  • Browser configurability to more effectively create study designs
  • User-friendly browser interface with drag and drop functionality
  • Integrated reporting
  • Real-time data management and analysis with audit trail management
  • Flexible data capture with image-based eCRFs and ePRO
  • Modular platform configuration to support the integration of strategic partners and custom applications
  • Extensive customer support and training
  • Compliance with GCP, 21 CFR Part 11 and other regulatory guidance
  • Support for CDISC standards

How SaaS-based EDC Enables Faster and More Cost Effective Clinical Trials

Introduction
This white paper is intended to assist clinical research professionals investigating the advantages of electronic data capture (EDC) and its evolution to a "Software as a Service" (SaaS) platform. It is aimed not only at organizations conducting paper-based studies and contemplating the move to EDC, but also at those already using EDC that want to reduce, stabilize and better predict study costs.

 
 

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