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BioClinica’s PET project
NEWTON, Pa.—In a partnership that would allow it to further augment its positron emission tomography (PET) capabilities and expertise for molecular imaging trials, BioClinica has taken the wraps off a collaborative agreement with Mirada Medical to integrate Mirada's XD3 software solution into BioClinica's existing core lab technology.
According to Timor Kadir, chief science and technology officer at Oxford, England-based Mirada Medical, BioClinica provides the opportunity for Mirada to deploy its image-analysis software in a wide range of image-based clinical trials.
"BioClinica brings expertise in the trial market, a high-end platform for trial and data management and access to a large number of trials," he says.
Under the partnership, Kadir notes that Mirada will provide a number of licenses to its XD3 software along with an API for integration. Mirada will also provide expertise to support the integration work and training on the use of the software.
Kadir says there may be need for some interface changes and software configuration to support this stage. In the longer term, Mirada and BioClinica will work together to further advance the software's capabilities to support clinical trial workflows.
The partnership, Kadir says, will foster the development of new image analysis methods and help Mirada push the boundary of what is currently possible.
According to Dr. Andy Dzik-Jurasz, BioClinica's senior medical director of medical affairs, following a careful evaluation of available molecular imaging solutions, BioClinica selected Mirada for its advanced image analysis capabilities and ability to handle not only PET images, but CT and MRI as well.
"While evaluating PET imaging software options, BioClinica was not only looking for the latest cutting-edge technology, but also the interest and ability to collaborate and develop a partnership," he says. "Mirada's XD3 software is designed to analyze current and likely future clinical trial imaging outputs, and has a modular architecture that allows for easy implementation of additional analysis components."
BioClinica's strategy goes beyond a standard utilization of Mirada 's software by creating a strategic partnership that will foster innovation as the molecular imaging field continues to develop. BioClinica will integrate Mirada's XD3 image analysis software platform into its processes and workflows, adopting an innovative design that will advance the clinical capabilities of BioClinica technologies such as BioPACS and BioREAD.
Dzik-Jurasz explains that a primary goal of this partnership "is to continue to build and enhance BioClinica's imaging expertise as we develop our molecular imaging capabilities."
Kadir further notes that there are both short- and long-term goals for the partnership.
"In the short-term, we aim to integrate the Mirada XD3 software into BioClinica's imaging platform such that it can be directly launched," he says. "Results from the image reading session will be saved back into the database for storage and further processing of results. This integrated solution will then be available for deployment in the relevant clinical trials."
In the longer term, Mirada aims to develop new capabilities within the software suitable for the clinical trial market.
"Such capabilities might include new workflow features, new quantification methods or even new algorithms as appropriate," Kadir says. "In the ideal case, any new methods developed would be available for translation into the clinic should the drug prove successful in trial."
Rather than "reinvent the wheel," Dzik-Jurasz explains that BioClinica will utilize the advanced features and capabilities of Mirada's software for a number of end-points to provide PET analysis and review as part of the routine BioClinica workflow.
"Sponsors who are accustomed to BioClinica's services will now have the expanded capabilities and superior results of PET scans and multi-modal technology," he says.
Through the partnership, Dzik-Jurasz says BioClinica will enable trial sponsors to achieve results by utilizing algorithms from new and upcoming imaging approaches that elicit a molecular or physiological signal.
"PET is one of the most exciting developments in oncology clinical trials, as it provides a better understanding of an investigative drug's impact on the subject and can show response sooner in the trial," he says.
BioClinica, NextDocs partnership aims to streamline clinical trial submission process
NEWTON, Pa.—BioClinica Inc. also announced March 23 that it has partnered with NextDocs, a global provider of Microsoft SharePoint-based compliance solutions to life- science organizations, to deliver solutions that aim to provide easier access to clinical trial information and decrease the timeline for U.S. Food and Drug Administration (FDA) clinical trial submissions.
Under their partnership agreement, the companies will merge BioClinica's OnPoint Clinical Trial Management System (CTMS) with NextDocs' Electronic Trial Master Form (eTMF) products.
BioClinica's OnPoint CTMS helps clinical trial sponsors and contract research organizations to access, share and analyze operational data using Microsoft SharePoint. NextDocs' eTMF provides customers a comprehensive document repository that simplifies the management of essential trial documentation and is compliant with the established Drug Information Association (DIA) reference model.
According to the companies, joining these two systems will create "a highly flexible workflow that reduces duplicate efforts and creates a seamless system for trial management and regulatory document routing." For example, as new trial sites are qualified for trial participation in BioClinica OnPoint, NextDocs' eTMF will automatically create the required regulatory document lists for the site. As these documents are reviewed, they are automatically submitted into the NextDocs workflow where they are routed for review and approval, signed off electronically, and formatted for clinical trial submission to the FDA.
OnPoint CTMS and NextDocs eTMF can also be deployed to the same SharePoint portal and sub-sites. This solution allows trial sponsors to access their study information through a single Microsoft SharePoint 2010 site. Trial managers can access eTMF documents, see document collection and approval status and perform CTMS functions, such as review subject enrollment information and site monitoring reports, all in the same place.
"As a company focused on advancing the field of clinical research, BioClinica is excited to partner with a leader like NextDocs and bridge the gap between CTMS and eTMF systems," said Peter Benton, BioClinica's president of eClinical Solutions, in a statement. "Our competitive success worldwide, especially in Europe, demonstrates the value of collaborative partnerships like this that make BioClinica the clinical trial solutions provider-of-choice for top- tier pharmaceutical companies."
"This partnership brings to the life-science industry critical advances to simplify and accelerate business processes," added Zikria Syed, CEO of NextDocs. "BioClinica is one of the top eClinical firms supporting global biopharmaceutical and medical device development, and we're pleased to work with them. Together, we'll help our mutual clients more effectively and efficiently manage clinical trial workflows."