June 28, 2013 | The Drug Information Association’s annual meeting is always a flurry of announcements and new products and this year is no different. Here is a roundup of some of the news briefs and products that have been announced this week in Boston. 

 

News Briefs  

 

Comprehend Systems and Merge Healthcare’s eClinical Solutions division have integrated Comprehend Clinical with Merge’s eClinical OS to enable Merge’s growing base of sponsor and contract research organization (CRO) customers to gain critical insights into end-to-end clinical and operational data—without the need for costly programming, data warehousing or business intelligence (BI) tools. Merge will provide its customers with data insights and reporting powered by Comprehend. Comprehend Systems 

 

Oracle announced several partnerships at DIA. Genetic Alliance, a non-profit health advocacy organization, has joined the Oracle Health Sciences Network to create a bridge linking individuals in its crowd-sourcing patient registry to clinical trials.  Also, Fountain Medical Development (FMD), a leading full-service contract research organization, will be using Oracle Health Sciences InForm to deliver high-quality, cost-effective electronic data capture (EDC) clinical trials services to its growing client base.

 

PHT Corporation has named Steven Rosenberg as the company’s Chief Operating Officer. At PHT, Steve will have responsibility for all aspects of product development, product management and service delivery. Steve was previously Vice President of Software and Services, Health Sciences Global Business Unit (HSGBU) at Oracle Corporation, and before that, Senior Vice President of Software and Services for Phase Forward. He was instrumental in the company’s success including the 2004 IPO and 2010 $685 million sale to Oracle. Press Release 

 

Products 

 

Evado E-Clinical has launched a cloud app—UniFORM—that promises to streamline clinical trials by allowing the management of  information and complex data from a single window/user-interface – regardless of software, format or user device. UniFORM will be available in the Fall of 2013. Press Release 

 

Oracle Health Sciences has expanded Oracle Argus Cloud Service.  The expansion enables global monitoring and delivers new insight into adverse events and pharmacovigilance programs.  Oracle also announced that InForm 6.0 is now available with Central Designer 2.0 includes several new features that streamline trial design, data collection management, and review. 

 

ERT announced enhancements to AVERT, its proven electronic suicide risk assessment system. Having already been used by over 32,000 clinical trial patients, AVERT is now available in both audio (phone) and visual (web/tablet) patient interfaces, offering greater flexibility to developers of new biopharmaceutical products. By using AVERT, clinical trial patients can comfortably and confidentially respond to a brief, SIB-related interview during investigative site visits or from home. If AVERT identifies an at-risk patient, the investigative site is alerted immediately, enabling them to take appropriate action per the protocol. ERT 

 

PHT Corporation has released the LogPad App System that collects compliant patient data using the latest Apple and Android smartphones, including patient’s own devices. The LogPad App gives sponsors and CROs the flexibility to deploy Phase II, III, and IV clinical studies along with post market and observational research to massive patient populations. PHT Corporation 

 

BioClinica has introduced StudyView, a clinical trials portal and reporting hub that dramatically increases clinical trials operational visibility. Powerful data visualization tools bring analytics to life with real-time data, informing operational decisions about clinical studies. StudyView is fully integrated with BioClinica's product suite and is 21 CFR Part 11 compliant. StudyView will leverage a suite of Microsoft business intelligence technologies such as Power View to create richly interactive dashboards and SQL Server Reporting Services (SSRS). This enables users to build a range of summary and granular reports and surface them directly in SharePoint 2013 to visualize and investigate their data in a dynamic and manner and connect directly to source applications to support further analysis and action. BioClinica 

 

 inVentiv Health has launched inVentiv Clinical Trial Recruitment Solutions (iCTRS) to solve the costly problem of identifying, recruiting and retaining patients and trial investigators. The new service helps trial sponsors accelerate recruitment, improve site productivity and reduce study timelines by merging inVentiv's vast proprietary database, communications expertise rooted in behavioral research and innovative digital technologies and social media to aid clinical trial sponsors. As part of inVentiv Health, iCTRS has the most comprehensive array of data assets and analytics capabilities in the industry, and uses algorithms to quickly identify the highest-performing investigators around the world. inVentiv Health 

 

Virtify has released Virtify SCM, a new software platform for creation, reuse and tracking of clinical and regulatory content. Virtify SCM (Structured Content Management) takes an asset management approach to improve collaboration and enables the automation of documents used throughout the drug product life cycle, from pre-clinical through product registration to commercialization. Virtify SCM improves compliance, productivity and quality while reducing risk across the drug product portfolio. Virtify SCM is a secure, collaborative, Web-based environment for managing regulated content through linked data components that automate and track all information known about a product, trial or objective at all stages of the development. Virtify SCM uses business rules-based templates and builds a library of re-useable content. It leverages organizational data across all operations, including R&D, submissions, labeling and marketing. Virtify SCM makes global regulatory compliance more routine, maximizing resources and producing more and better products in less time. Virtify 

 

PAREXEL has launched PAREXEL Functional Services within the company's Clinical Research Services business segment. PAREXEL created the unit to provide solutions for customers interested in outsourcing particular functions rather than full development programs in the clinical development process. The new operating unit will provide clinical operations, data management, biostatistics, and medical writing, among others. These services may be offered through a range of engagement models including insourcing/staffing, full functional outsourcing, as well as customized solutions. Functional sourcing may form the basis of a strategic partnership or may be part of a hybrid partnership model that includes both functional and programmatic outsourcing. The new operating unit will be staffed by a dedicated leadership team and supporting resources, taking full advantage of global resources and expertise from across PAREXEL's existing operations. PAREXEL Functional Services is one of several operating units PAREXEL has created to capitalize on market opportunities and evolving client needs. PAREXEL 

 

Deloitte and Intermountain Healthcare have launched OutcomesMiner, an analytics tool designed to give researchers, pharmaceutical and medical device companies the data-driven insight needed to conduct comparative effectiveness research and bring new therapies to market more rapidly. Leveraging electronic medical records (EMR) data, OutcomesMiner helps users understand associated outcomes for treatments and filter for sub-populations using phenotypic characteristics and specific medical associations.  The solution draws upon Intermountain's vast repository of electronic health records (EHRs) in supporting analysis around patient and product outcomes under a double-blinded format designed to protect the privacy of personal health information. Deloitte  

 

DATATRAK International has announced its next generation clinical trial management enterprise resource planning (ERP) solution. The DATATRAK ONE CLINICAL ERP release streamlines the clinical trial process through enhancements to DATATRAK's single database architecture. Data is now informational, actionable and visible for faster, better decision making. The DATATRAK ONE CLINICAL ERP solution is designed with a new, more intuitive user interface providing improved workflows and mobility. The global, real-time view of data enables users to proactively identify and address concerns that result in higher quality and operational efficiencies throughout the drug development process. DATATRAK