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WorldCare Clinical Introduces New Collect, Ready, Hold Service for Early-Stage and Phase II Trials

March 02, 2009

WorldCare Clinical, LLC (WCC), a leading imaging CRO for clinical trials in the pharmaceutical, biotechnology, and medical device industries, today introduced a new service offering to support sponsors conducting early-stage and Phase II clinical trials. WCC’s new Collect, Ready, Hold service saves sponsors time and money by allowing imaging data to be collected and standardized according to the imaging protocol and then held in a single, secure database until a central review of the data is requested.

WCC’s new Collect, Ready, Hold service builds upon the company’s extensive operational and regulatory expertise and employs its patent-pending WorldPro™ image management technology to acquire and prepare imaging data and store it all in a single, secure database. This gives sponsors complete control of the images acquired and helps them respond to the FDA or other regulatory agencies, streamlining review processes if needed. It also reduces time and site management costs by preventing sponsors from having to go back and collect images if a central review is requested at a later date. WCC’s WorldPro technology is also manufacturer-agnostic, meaning that DICOM images can be pushed to any CRO a sponsor chooses. This flexibility allows sponsors to use WCC to manage any or all portions of their trial as needed.

“Sponsors conducting Phase II trials many times either don’t have the funding in place or have yet to receive a request from the FDA to conduct a central review of their imaging data,” said Richard Walovitch, WCC’s chief medical officer. “Collect, Ready, Hold was developed in response to these challenges as a cost-effective and preemptive approach for sponsors to collect, QC and store images in a central database until it is determined if a central review of the imaging data is required. This process not only eliminates monthly management fees, but also decreases the time required to provide data to the FDA. Sponsors also receive the added benefit of working with a proven, patent-pending technology system already supporting a multitude of trials.”

The new service offering consists of the following:

  • Collect: WCC writes the image acquisition protocol, identifies and qualifies sites, and standardizes the image acquisition collection;
  • Ready: WCC performs administrative and technical QC of the images submitted from sponsor study sites and resolves any issues identified;
  • Hold: WCC holds the images in a database until it is determined if a central review of the imaging data is required.
  • For more information about WCC’s Collect, Ready, Hold capabilities, visit: wcclinical.com.