Online Exclusives

News Highlights from the 2016 Annual DIA Meeting

July 6, 2016

Comprehend Launches Clinical Intelligence Suite, Quintiles Launches CGM Service Offering, and more...

Comprehend Launches Clinical Intelligence Suite
Comprehend Systems, Inc. has launched its Clinical Intelligence Suite specifically designed to meet the diverse and evolving needs of clinical teams, from Clinical Operations and Data Management to Clinical Development and Medical Monitors.
 
The Clinical Intelligence Suite consists of three applications and a cross-application add-on:
  • ClinOps Insights is aimed at optimizing portfolio oversight, enrollment, subject compliance and site productivity processes.
  • Centralized Monitoring enables ClinOps to proactively managestudies to risk thresholds and optimize site resource allocation.
  • Medical Insights provides Medical Monitors with insights into medical outliers and trends.
  • KPI Studio - a cross-application add-on - allows Data Management teams to create organization specific KPIs, KRIs, monitors and analytics.
“We were familiar with other software on the market but they required heavy-handed technical experience and ‘real time’ for them involved a 24-hour cycle for clinical operations reporting. Comprehend is truly real time and offers continuous quality throughout our clinical operations, while also ensuring IT is not a bottleneck for the clinical operations team,” said the director of Clinical Data Management at a Large Life Sciences Sponsor.
 
Rick Morrison, chief executive officer of Comprehend Systems said, “We have collaborated with both large and innovative life sciences companies to develop the industry’s first Clinical Intelligence Suite. Our customers benefit from better use of resources, avoiding CRO change orders and cost overruns due to enrollment and data quality delays. Our customers have also reduced safety and data quality risk by monitoring key performance indicators and ensuring the right escalation occurs at the earliest possible time.”
 
ICON to Acquire ClinicalRM
ICON plc has agreed to acquire Clinical Research Management Inc. (ClinicalRM), expanding its access to government sponsored research and its capabilities in vaccines and infectious disease.
 
ClinicalRM provides full service and functional research services to range of U.S. government agencies with expertise across basic and applied research, infectious diseases, vaccines development and testing and bio-threats. They have also worked with government and commercial customers to respond to global viral epidemics.
 
ICON’s chief executive officer, Ciaran Murray said, “The market for government sponsored research is significant with over fifteen hundred active clinical studies being funded by the National Institutes of Health or other federal agencies. ClinicalRM has strong relationships and a deep understanding of what is required to partner successfully with government sponsors. ClinicalRM’s experience in responding to the challenges of global viruses will further enhance ICON’s capabilities in the areas of vaccines and infectious disease.”
 
Victoria Tifft, chief executive officer of ClinicalRM added, “We are delighted to be joining ICON. By combining ClinicalRM’s expertise in government sponsored research with ICON’s breadth of services and global footprint we will be able to bring additional services and thought leadership to our customers. We are also excited about the potential the combination has to further innovate drug development in the area of Vaccines and Infectious diseases.”
 
DZS Clinical Services Launches ClinPlus 3.1  
DZS Clinical Services, a provider of clinical development and data analytic services, launched its ClinPlus 3.1 eClinical software at DIA in Philadelphia.
 
The ClinPlus eClinical Platform combines electronic data capture, a clinical trial management system, an interactive web response system and eTMF functionality into a single platform. The eClinical software aims to maximize productivity and minimize risk in clinical programs by centrally managing system and project security, global contacts and institutions, project design reports and notifications.
 
“The enhanced ClinPlus eClinical software will really be a differentiator. Through ClinPlus, coupled with our full-service clinical development strategy, we provide a direct line to improved clinical trial performance for our clients,” said Greg Ambra, vice president of clinical operations at DZS Clinical Services. “Having EDC, CTMS, IWRS and eTMF functionality unified under one proprietary software platform provides maximum flexibility, functionality and efficiency for our clients.”
 
The software has a simplified role-based user interface that requires a single sign-in to access all eClinical components. According to the company, the upgraded software platform also replaces EDC and CTMS integrations with simple mapping and web APIs when users need to integrate with third-party systems.
 
Quintiles Launches CGM Service Offering
Quintiles launched its new Continuous Glucose Monitoring (CGM) service offering that combines wearable technology with Quintiles’ therapeutic and analytical expertise aimed at helping to enhance the efficiency and quality of diabetes-focused clinical trials. The new CGM offering provides investigators with access to customized data analytics and performance reports through Quintiles’ Infosario technology platform.
 
These optimized glycemic data sets can be analyzed to uncover trends such as non-compliance and potential safety triggers. In addition, Quintiles experts from the company’s Diabetes Center of Excellence will provide dedicated support for the offering.
 
“According to the International Diabetes Federation (IDF), every six seconds, a person dies from diabetes-related causes and almost half of those deaths are people under the age of 60,” said Margaret Keegan, president of Data Sciences, Safety and Regulatory Services at Quintiles. “With diabetes diagnoses on the rise, the need for innovative and accessible treatments also increases. CGM can provide a variety of in-depth measures from diabetes patients – information that can be used to enhance the way patients are treated for diabetes and why this new offering is so critical.” 
 
Through the offering, continuous glucose measurements will be captured by a wearable sensor and wirelessly sent to a receiver, recording readings throughout the day. In the clinical trial setting, this timely glucose visibility has the potential to improve patient safety, accelerate clinical development and provide a basis for differentiated claims
 
Center Point Clinical Partners with ContraVir Pharmaceuticals
ContraVir is using Center Point Clinical Services’ CTRP solution for medication compliance in the company’s Phase III study of FV-100, an experimental oral treatment for shingles.
 
Center Point will continue to provide its CTRP solution to support the clinical sites participating in ContraVir’s Phase III, randomized study of FV-100, in development as a fast-acting, low-dose, once-daily, oral antiviral therapy for the treatment of herpes zoster, or shingles.  
 
CTRP is a patient engagement service that uses licensed, specially trained clinical pharmacists to communicate with study patients, the clinical sites, the CRO, and the study sponsor. The CTRPs engage patients at important stages of the trial to confirm study medication guidelines are clearly understood and being properly followed. All discussions between CTRPs and patients are documented and shared with the trial team.
 
“ContraVir is taking every measure to make sure that the Phase III FV-100 study for shingles proceeds professionally and smoothly. Crystal clear communication amongst all involved is essential to achieving these goals and robust outcomes. Securing strong channels of communication and patient engagement are CTRP specialties. Center Point’s capable, experienced and personable pharmacists prove their value daily. The trial patients are more compliant because of their expertise and personal attention and the trial team is better informed and in a timely manner.  For these reasons, we are very pleased to be working with Center Point,” said Terri Matkovits, senior vice president of Drug Development at ContraVir.
 
“We are delighted to continue our important partnership with ContraVir, a leader in the pharmaceutical industry, tirelessly working to bring effective anti-viral therapies to the market for conditions like shingles and hepatitis B. We are confident that the CTRP solution will continue to make a tremendous positive impact on the company’s Phase III study by increasing patient compliance and creating an efficient information flow between the team,” said Joe Martinez, chief executive officer of Center Point.
 
ClinDatrix Launches Oracle InForm 6.1 and Argus 8.0
ClinDatrix a CRO located in Irvine, CA, has launched Oracle Health Sciences InForm 6.1 and Oracle Argus 8.0, in an effort to improve clinical development processes, streamline data capture, speed up trial timelines and enhance pharmacovigilance services. 
 
ClinDatrix offers clinical monitoring, medical safety management and monitoring, event planning, data management, biostatistics, programming to CDISC standards, medical writing, regulatory affairs including eCTD submissions, and quality assurance services. 
 
ClinDatrix plans to use Oracle’s electronic data capture technology to gain deeper and faster insight into clinical trial data, to help sponsors improve the speed, quality, efficiency, and cost of their clinical studies. 
 
With the implementation of Oracle Argus 8.0, ClinDatrix can provide efficiencies and have the increased ability to support global safety collection and risk management efforts. Argus 8.0, including Interchange, offers efficient processing and submission of Case Safety Reports to regulatory agencies. Oracle Health Sciences InForm offers support for industry standards, such as CDISC, to increase efficiency and time for trial design and setup and enhance data collection and reporting quality. 
 
“Our industry-leading clinical development, management, and safety solutions empower CRO’s to optimize clinical productivity and deliver clinical data innovation and business value while managing critical regulatory requirements with confidence,” said MaryAnne Rizk, Ph.D., vice president of Global CRO Partner Business Oracle Health Sciences.

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