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
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.
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
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 21(st) 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.
Keywords for this news article include: Technology, inVentiv Health, Clinical Trials and Studies.
Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC
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