Updated DIA News and New Products
Lots of product news coming out of the Drug Information Association annual meeting that started today in San Diego. Here are some of the highlights. We’ll be adding to this list throughout the week.
-- The Editors
Wednesday, June 18
Verizon Focuses on Pharma Sector
In order to expand into the pharmaceutical and life sciences industries, Verizon is launching a portfolio of GxP (Good x Practices) Services for managing sensitive clinical and drug manufacturing data in the Verizon cloud or from select data centers. The services are available in the U.S. and Europe, and include focuses on foundational security, supporting alternative cost models, and enabling outsourcing of existing non-strategic systems. “In working with our pharmaceutical and life sciences clients, we realized many require a secure, enterprise-grade IT solution that can address their ever-growing regulatory requirements,” said Chris Davis, managing principal, healthcare, in a prepared statement. “Verizon developed its GxP services to enable our clients to securely scale their operations by outsourcing their IT infrastructure.”
CenterWatch, TrialReach Partnerships
CenterWatch and TrialReach have reached an agreement to offer all TrialReach users access to CenterWatch’s online professional, educational and informative services and resources including trial listings seeking study volunteers from the Clinical Trials Listing Service (CTLS). Conversely, CenterWatch’s patient visitors will have access to TrialReach’s database of more than 270,000 clinical trials.
PHT Rolling Out SitePad on Dell Protablets, Windows 8.1
PHT Corporation has chosen Dell Venue 11 Protablets running Windows 8.1 to use for its SitePad System to collect patient-driven electronic data. The SitePad System replaces traditional paper data collection methods in clinical research with electronic methods, providing better-quality data, real-time access to that data and, ultimately, faster time to data analysis for pharmaceutical trial sponsors. Each SitePad is configured for a specific study protocol and used by clinicians and patients participating in the trial to collect study-specific assessments. PHT chose the Dell tablets and Windows 8.1 for 2,000 devices, about half of their yearly supply. “We’ve been working on a Microsoft platform for a number of years,” Sheila Rocchio, vice president of Marketing & Product Management at PHT, said. She called out Microsoft’s security and flexibility as key features. For the Dell Protablet, Rocchio said PHT particularly liked the screen, and the connectivity afforded by the ability to have an Ethernet card. Clinical sites might be working out of a basement and unable to get WiFi, she said. “Right now we’re still in a world where ubiquitous connectivity isn’t always available.”
Monday, June 16
Adaptive Recruitment and Clinical Trial Apps
BBK Worldwide is presenting a new model of patient recruitment: adaptive recruitment. Designed specifically to protect global enrollment integrity, adaptive recruitment helps sites and sponsors maximize tight budgets and timeframes by offering the tools and best-practices needed to ensure more informed recruitment and enrollment decisions. BBK also launched two mobile apps for patient and site engagement, My Clinical Study Buddy and My Clinical Study Buddy Protocol Pointers Edition. Both apps are available today in the App Store and Google Play. My Clinical Study Buddy provides enrolled patients with appointment reminders, visit details, resources, videos, maps and site contact links using the company's comprehensive recruitment platform TrialCentralNet.
Japanese Support for Patient Recruitment
BBK and its partner CROèe, a leading Japanese CRO, are forming a joint US-based company: BBK + CROèe. The new entity supports the expansion of both companies’ product offerings and sales channels, and the increasing need for Japanese-supported patient recruitment services. BBK + CROèe will offer a fully integrated patient recruitment system; a system that combines BBK’s TrialCentralNet (TCN) recruitment platform and CROèe’s iPass system. The fully integrated solution will be available by the end of June.
Expanding Review Boards
The WIRB-Copernicus Group, the world's largest provider of regulatory and ethical review services for clinical research, announced today that two independent review boards (IRBs)—Aspire IRB and Midlands IRB—have joined the Group. Located near to San Diego, CA and Kansas City, MO, respectively, these companies expand WCG’s presence in two major clinical research hubs, and in Early Phase (I & II) reviews. Press Release
State of the Trial Master File
Veeva Systems released the results of its Veeva 2014 Paperless TMF Survey: An Industry Benchmark. This The survey of more than 250 trial master file (TMF) owners found that 57% still use paper or simple electronic file systems to manage their TMF. Only about one in ten respondents (13%) use an eTMF application to manage their TMF. For those using process-driven eTMF applications and content management systems, 47% realize cost savings, as compared to only 29% of those using a local file system. 81% of those with eTMF applications report good or major improvement in misfiled documents, compared to 62% of local file system users. Email (69%) and paper (57%) remain the predominant means of exchanging trial documents with sponsors/CROs.
Electronic Investigator-Controlled Site File
Intralinks Holdings has launched an electronic investigator-controlled site file (eISF) solution, a simple online document storage tool for investigator sites involved in the clinical trial process. The new solution is designed to dramatically improve regulatory compliance and efficiency at the investigator site while revolutionizing how sponsors can maintain oversight of participant sites by enabling study monitors and inspectors to no longer have to view investigator documents in person. Intralinks eISF is designed to securely store all of the documents for each site across studies and sponsors, while helping to ensure the investigator maintains control even when sharing sensitive content. In addition, sponsor eTMF filing is improved by prioritizing content received from sites’ eISF based on metadata, and the improved quality of the site documentation will have undergone a more rigorous review process. Press Release
New Platforms for Spirometry, Electronic Clinical Outcomes Assessment
ERT launched MasterScope 2.0, a new, comprehensive platform for spirometry, ECG, and home monitoring. Especially designed for standardized and centralized clinical trials, MasterScope 2.0 offers complete pulmonary function testing exceeding current ATS/ERS standards, combines home monitoring data from ERT’s AM3 family, and integrates an optional 12-lead digital ECG utilizing the ERT HES algorithm. ERT says that MasterScope 2.0 is the only spirometer for clinical trials that provides biometric fingerprint identification that is in compliance with the U.S. FDA’s 21 CFR 11 requirements. ERT Respiratory Solutions
ERT also announced an extension to its DIARYpro solution for electronic Clinical Outcome Assessment (eCOA). Clinical trial sponsors can reliably collect important eCOA data via patients’ personal Apple or Android phones and tablets. The app allows fully-offline operation for when data must be entered during strict time windows, regardless of internet connectivity. ERT Clinical Outcome Assessment
New EDC Delivery Systems
MedNet is presenting three EDC delivery programs, each designed to support the unique needs and requirements of our customers. iMedNet iBuild is developed for pharma, biotech, IVD and medical device companies wishing to efficiently build their own studies in-house. It includes comprehensive iMedNet Designer training and support services to ensure the success of each research initiative. The iMedNet Partner program was created specifically for CROs and healthcare consultants looking for a fast, easy-to-use and cost-effective do-it-yourself eClinical solution. It includes complete sales and marketing support, iMedNet Advisory Forum membership and special pricing discounts. Finally, the iMedNet Access program is ideal for any organization wanting to outsource their iMedNet study configurations for any reason. MedNet’s Professional Technology Services Team provides turnkey setup and deployment services, from system build and testing to end-user support.
Integrate and Analyze Clinical Data
Oracle launched their Health Sciences Data Management Workbench, through which researchers can integrate, reconcile and analyze clinical data faster and more accurately, and automate data load, transform and cleanse processes. The solution is integrated with Oracle Life Sciences Data Hub
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