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SOURCE inVentiv Health
Partnership with ViS Research Has the Potential to Cut in Half the Time Needed to Conduct Clinical Trial Feasibility Studies Through Process Innovation
BURLINGTON, Mass., Jan. 23, 2014 /PRNewswire/ -- inVentiv Clinical Trial Recruitment Solutions (iCTRS), an inVentiv Health company leading the biopharmaceutical sector in reducing the time to the start of clinical trials, announced today that the process innovations offered by its partnership with ViS could cut in half the time required to conduct feasibility studies.
The most recent report issued this month by the Tufts Center for the Study of Drug Development noted that the drug development model had not fundamentally changed in years, and that the future success of pharmaceutical companies will depend in part on their ability to adopt greater efficiencies and best practices.
One area ripe for improvement is clinical site feasibility in the planning for trial. Even though the selection of sites capable of enrolling patients is a critical step to ensuring the smooth operation of a clinical trial, site selection is fraught with inefficiencies. An estimated $10 billion a year is wasted because of poor site selection.
The use of technology is critical to process improvement in feasibility. To demonstrate the potential for savings, iCTRS took data from 100 feasibility studies conducted by inVentiv, and analyzed the time required to perform each of the individual tasks involved in such studies. The company then looked at how much time the application of ViS technology could save for each task. Cumulatively, the efficiencies offered by ViS cut the total feasibility study hours by 54% -- while delivering better quality. Additional time savings potentially could be realized by applying other technologies in the iCTRS portfolio.
ViS Research, creator of the world's first comprehensive online feasibility platform, gives trial planners better, real-time data for the efficient evaluations of locations, sites, investigators, and networks for possible inclusion in clinical trials. The ViS global map of clinical research infrastructure, assembled over a decade of research, includes detailed and vetted information on more than 400,000 disease-specific centers.
Research centers and investigators can efficiently share their capabilities by uploading a profile on the digital platform where the information can be stored and updated regularly, eliminating redundant paper questionnaires. Up until now, many investigators chose to not participate in feasibility because it was so difficult. Instead of answering the same questions multiple times, investigators can now build upon the existing profile and focus on answering protocol-specific questions that will help differentiate their site from another site being considered.
For trial sponsors, the ViS profile provides answers to 85% of the routine questions they normally ask. Sponsors can review the profiles, use the platform to contact investigators and gather additional information. High-quality analytics and visualization tools allow sponsors to quickly and easily compare sites and feasibility data for accelerated selection of sites that are properly equipped, staffed, and ready to be activated for study participation.
"At the end of the day, this is all about doing feasibility studies better, faster and getting drugs and devices into quality clinical trials at an accelerated rate," said Ramita Tandon, senior vice president and general manager for iCTRS. "In the next phase of development on the ViS platform we'll accelerate processes even more."
iCTRS this month launched its own proprietary network on the ViS platform, using the social media functions that enable far easier networking. iCTRS is the only service provider with rights to use the ViS database for building its own social network. Investigators will have access to information on new trial opportunities posted by iCTRS, while sponsors can share information on upcoming trials and more closely interact and collaborate with investigators.
iCTRS and ViS are developing additional, exclusive functionality, including automating the workflow process for confidential disclosure agreements (CDA) and the onboarding of clinical trial investigators. Streamlining and simplifying processes will help attract and retain more high-quality investigators who can enroll patients, conduct efficient trials and move the start-up phases of the drug development process into the 21st century.
iCTRS was specifically created to integrate a game-changing set of global capabilities to accelerate trials in a predictable and cost-efficient way. "It's all about hitting timelines, and it starts with feasibility. This is the first place we challenge assumptions about old ways of doing trials and find efficiencies through technology to do things better," Tandon said.
About inVentiv Health
Our broad range of services and our global scale, represented by approximately 12,000 employees supporting clients in more than 70 countries, allow us to serve as a critical strategic partner for pharmaceutical, biotechnology, medical device and diagnostics, and healthcare companies in their dynamic and rapidly changing regulatory and commercial environments. We serve more than 550 client organizations, including all 20 of the largest global pharmaceutical companies. For more information, visit http://www.inVentivHealth.com.
About ViS Research (ViS)
The ViS online feasibility platform is the first to integrate analytics about investigators, sites, networks, and trial locations, while enabling engagement between trial planners and sites. Trial planners use interactive visualizations to navigate the intricate, disease-specific decision matrix to immediately gather feasibility information from 400,000+ disease-specific research sites and 360,000+ investigators. ViS helps these investigative sites by decreasing their administrative burden related to feasibility questionnaires, while enabling them to efficiently display their disease-specific capabilities, at no cost. The end result is that optimal decisions can be reached using a small fraction of the time and cost incurred through conventional methods. ViS Research was created as a global enterprise in 2010, with trial planning experts in four continents. More information at http://www.visresearch.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause our performance to differ materially. These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. Such factors include, without limitation: the impact of our substantial level of indebtedness on our ability to generate sufficient cash to fulfill our obligations under our existing debt instruments or our ability to incur additional indebtedness; the impact of customer project delays and cancellations and our ability to sufficiently increase our revenues and manage expenses and capital expenditures to permit us to fund our operations; the impact of the consummation of our acquisition of Catalina Health Resource, LLC and any future acquisitions; the impact of any change in our current credit ratings and the ratings of our debt securities on our relationships with customers, vendors and other third parties; the impact of any additional leverage we may incur on our ratings and the ratings of our debt securities; our ability to continue to comply with the covenants and terms of our senior secured credit facilities and to access sufficient capital under our credit agreement or from other sources of debt or equity financing to fund our operations; the impact of any default by any of our credit providers; our ability to accurately forecast costs to be incurred in providing services under fixed price contracts; our ability to accurately forecast insurance claims within our self- insured programs; the potential impact on pharmaceutical manufacturers, including pricing pressures, from healthcare reform initiatives or from changes in the reimbursement policies of third-party payers; our ability to grow our existing client relationships, obtain new clients and cross-sell our services; the potential impact of financial, economic, political and other risks, including interest rate and exchange rate risks, related to conducting business internationally; our ability to successfully operate new lines of business; our ability to manage our infrastructure and resources to support our growth, including through outsourced service providers; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operation, and achieve the resulting synergies; any disruptions, impairments, or malfunctions affecting software as well as excessive costs or delays that may adversely impact our continued investment in and development of software; the potential impact of government regulation on us and on our client base, including the impact of the final HIPAA Privacy Rule on the willingness of pharmaceutical manufacturers to sponsor patient adherence programs; our ability to comply with all applicable laws as well as our ability to successfully adapt to any changes in applicable laws on a timely and cost effective basis; our ability to recruit, motivate and retain qualified personnel; any potential impairment of goodwill or intangible assets; consolidation in the pharmaceutical industry; changes in trends in the healthcare and pharmaceutical industries or in pharmaceutical outsourcing, including initiatives by our clients to perform services we offer internally; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the actual impact of the adoption of certain accounting standards; and our ability to maintain technological advantages in a variety of functional areas, including sales force automation, electronic claims surveillance and patient compliance. Holders of our debt instruments are referred to reports provided to investors from time to time and the offering memoranda provided in connection with the issuance of our notes for further discussion of these risks and other factors.
ViS Research Contact:
Office: +1 781 425 4624
+1 917 715 2820
Mobile: +1 202 210 5992
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