BioClinica’s PET project

NEWTON, Pa.—In a partnership that would allow it to furtheraugment its positron emission tomography (PET) capabilities and expertise formolecular imaging trials, BioClinica has taken the wraps off a collaborativeagreement with Mirada Medical to integrate Mirada's XD3 software solution intoBioClinica's existing core lab technology.

According to Timor Kadir, chief science and technologyofficer at Oxford, England-based Mirada Medical, BioClinica provides theopportunity for Mirada to deploy its image-analysis software in a wide range ofimage-based clinical trials.

"BioClinica brings expertise in the trial market, a high-endplatform for trial and data management and access to a large number of trials,"he says.

Under the partnership, Kadir notes that Mirada will providea number of licenses to its XD3 software along with an API for integration.Mirada will also provide expertise to support the integration work and trainingon the use of the software.

Kadir says there may be need for some interface changes andsoftware configuration to support this stage. In the longer term, Mirada andBioClinica will work together to further advance the software's capabilities tosupport clinical trial workflows.

The partnership, Kadir says, will foster the development ofnew image analysis methods and help Mirada push the boundary of what iscurrently possible.

According to Dr. Andy Dzik-Jurasz, BioClinica's seniormedical director of medical affairs, following a careful evaluation ofavailable molecular imaging solutions, BioClinica selected Mirada for itsadvanced image analysis capabilities and ability to handle not only PET images,but CT and MRI as well.

"While evaluating PET imaging software options, BioClinicawas not only looking for the latest cutting-edge technology, but also theinterest and ability to collaborate and develop a partnership," he says."Mirada's XD3 software is designed to analyze current and likely futureclinical trial imaging outputs, and has a modular architecture that allows foreasy implementation of additional analysis components."

BioClinica's strategy goes beyond a standard utilization ofMirada's software by creating a strategic partnership that will fosterinnovation as the molecular imaging field continues to develop. BioClinica willintegrate Mirada's XD3 image analysis software platform into its processes andworkflows, adopting an innovative design that will advance the clinicalcapabilities 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 wedevelop our molecular imaging capabilities."

Kadir further notes that there are both short- and long-termgoals for the partnership.

"In the short-term, we aim to integrate the Mirada XD3software into BioClinica's imaging platform such that it can be directlylaunched," he says. "Results from the image reading session will be saved backinto the database for storage and further processing of results. Thisintegrated solution will then be available for deployment in the relevantclinical trials."

In the longer term, Mirada aims to develop new capabilitieswithin the software suitable for the clinical trial market.

"Such capabilities might include new workflow features, newquantification methods or even new algorithms as appropriate," Kadir says. "Inthe ideal case, any new methods developed would be available for translationinto the clinic should the drug prove successful in trial."

Rather than "reinvent the wheel," Dzik-Jurasz explains thatBioClinica will utilize the advanced features and capabilities of Mirada'ssoftware for a number of end-points to provide PET analysis and review as partof the routine BioClinica workflow.

"Sponsors who are accustomed to BioClinica's services willnow have the expanded capabilities and superior results of PET scans andmulti-modal technology," he says.

Through the partnership, Dzik-Jurasz says BioClinica willenable trial sponsors to achieve results by utilizing algorithms from new andupcoming imaging approaches that elicit a molecular or physiological signal.

"PET is one of the most exciting developments in oncologyclinical trials, as it provides a better understanding of an investigativedrug's impact on the subject and can show response sooner in the trial," hesays.

BioClinica, NextDocs partnership aims to streamlineclinical trial submission process

NEWTON, Pa.—BioClinica Inc. also announced March 23 that ithas partnered with NextDocs, a global provider of Microsoft SharePoint-basedcompliance solutions to life- science organizations, to deliver solutions thataim to provide easier access to clinical trial information and decrease thetimeline for U.S. Food and Drug Administration (FDA) clinical trialsubmissions.

Under their partnership agreement, the companies will mergeBioClinica's OnPoint Clinical Trial Management System (CTMS) with NextDocs'Electronic Trial Master Form (eTMF) products.

BioClinica's OnPoint CTMS helps clinical trial sponsors andcontract research organizations to access, share and analyze operational datausing Microsoft SharePoint. NextDocs' eTMF provides customers a comprehensivedocument repository that simplifies the management of essential trialdocumentation and is compliant with the established Drug InformationAssociation (DIA) reference model.

According to the companies, joining these two systems willcreate "a highly flexible workflow that reduces duplicate efforts and creates aseamless system for trial management and regulatory document routing." Forexample, as new trial sites are qualified for trial participation in BioClinicaOnPoint, NextDocs' eTMF will automatically create the required regulatorydocument lists for the site. As these documents are reviewed, they areautomatically submitted into the NextDocs workflow where they are routed forreview and approval, signed off electronically, and formatted for clinicaltrial submission to the FDA.

OnPoint CTMS and NextDocs eTMF can also be deployed to thesame SharePoint portal and sub-sites. This solution allows trial sponsors toaccess their study information through a single Microsoft SharePoint 2010 site.Trial managers can access eTMF documents, see document collection and approvalstatus and perform CTMS functions, such as review subject enrollmentinformation and site monitoring reports, all in the same place.

"As a company focused on advancing the field of clinicalresearch, BioClinica is excited to partner with a leader like NextDocs andbridge the gap between CTMS and eTMF systems," said Peter Benton, BioClinica'spresident of eClinical Solutions, in a statement. "Our competitivesuccess worldwide, especially in Europe, demonstrates the value ofcollaborative partnerships like this that make BioClinica the clinical trialsolutions provider-of-choice for top-tier pharmaceutical companies."

"This partnership brings to the life-science industrycritical advances to simplify and accelerate business processes," added ZikriaSyed, CEO of NextDocs. "BioClinica is one of the top eClinical firms supportingglobal biopharmaceutical and medical device development, and we're pleased towork with them. Together, we'll help our mutual clients more effectively andefficiently manage clinical trial workflows."