Almac Adds Supply Chain, Patient Compliance ServicesAlmac showcased new enhancements to its suite of Integrated Supply Chain Management and Patient Compliance Services. The new services include Shipping Temperature Electronic Monitoring System (STEMS), SMS/Text patient reminders, and consultation on packaging and labeling designs aimed at improving patient compliance.
STEMS is a web-enabled, validated data management system that helps assure pharmaceutical products are monitored within acceptable temperature ranges during shipping. STEMS provides immediate visibility on shipment temperature reports and allows users to make instant decisions on temperature data for the management of drug supplies.
Robert Dunlop, president of Almac’s Clinical Services, commented, “STEMS satisfies an important need of our clients: making certain that drugs used in clinical trials are closely monitored for temperature excursions. By facilitating data upload and removing the need to return temperature control monitors, STEMS significantly streamlines the clinical supplies logistics process.”
Almac also featured enhancements to its Patient Compliance service offering aimed at improving compliance from initial recruitment to study closeout, including: Consulting on Packaging and Label Design for trial supplies and patient reminder services for a variety of tasks during a clinical trial.
Almac’s president of Clinical Technologies, Jim Murphy, said, “Almac is unique in the industry because we offer services that focus on driving patient compliance throughout the patient’s journey in a clinical trial. Our multi-modal patient reminder services (SMS/text, email and outbound calls) as well as Almac’s expertise in consulting and delivering supplies packaging and labeling services, provide sponsors with a variety of options to improve compliance rates and assure patients adhere to study protocols.”
Firecrest Launches New Mobile ApplicationFirecrest launched its new Mobile Visit-by-Visit Guide application designed specifically for site personnel. The application allows site personnel to be equipped with a portable, interactive version of training and study procedure essentials required during a patient visit or clinical trial. The mobile application contains all the original and best features of the study portal’s Visit-by-Visit Guide decision support tool, and now it has been developed for use on an iPad.
The application can cover everything from patient consent information, step-by-step study procedures, training modules and other necessary information regarding a clinical trial and can be accessed on the spot.
SAS, Aptiv Partner On Advanced Trial DesignSAS and Aptiv Solutions have partnered to develop advanced clinical trial design and deployment of adaptive clinical trials. The two companies will work to automate workflow and improve drug trial design through simulation and efficient execution. This vigorous and scalable approach to drug development is designed to eliminate operational barriers to performing adaptive clinical trials and can be applied to both drugs and medical devices.
"The difficulties facing companies developing products in life sciences continue to intensify," said Jason Burke, director, SAS Center for Health Analytics and Insights (CHAI). "Companies that rely on conventional techniques risk missing out on emerging opportunities and the successes that typically follow. Adaptive clinical trials can mean the difference between being a market leader and lagging behind."
Aptiv Solutions chairman and chief executive officer Patrick Donnelly, said, "We are sharply focused on harnessing the power of adaptive clinical trials. Aptiv Solutions has combined advanced simulation and software capabilities with the knowledge of adaptive clinical trial subject-matter experts and broad capabilities, and as a global CRO, Aptiv Solutions possesses deep process knowledge and flexibility in running global clinical trials. Pharmaceutical, biotech and medical device companies look to Aptiv Solutions to expose the pitfalls and unfulfilled promise of traditional development methods, while providing new alternatives and results."
Quintiles Launches InfosarioQuintiles released Infosario, a web-based, business-to-business platform that allows customers to leverage data for improved collaboration and decision-making throughout the drug development process.
“Quintiles Infosario is a fully integrated platform that enables significant advances in the drug development process,” said Tom Grundstrom, Quintiles Infosario Global Head. “The innovative technology makes it possible to turn the wealth of data that our company possesses into actionable insights for our customers. Through the platform’s intuitive user interface, key stakeholders will be able to make faster, better-informed decisions about the programs and therapies they are working on.”
Infosario integrates, synchronizes and standardizes subject, operational and management data across multiple systems. According to the company, the platform transforms data and information into meaningful insights to customers using a secure, web-based front end with a simple, easy to navigate drill path from insight to clinical data. Customers can also fulfill all or parts of their clinical IT system needs through Infosario’s cloud-based Systems as a Service. Infosario combines IT provisioning, including configured systems with core clinical business process delivery.
“The release of Quintiles Infosario marks an important new day for both the biopharmaceutical industry and those patients who benefit from their breakthroughs,” said Paula Brown Stafford, president of Quintiles Clinical Development. “At Quintiles, we believe our broad expertise uniquely positions us to partner with leading biopharmaceutical companies to turn foundational data into transformational information that can be used to greatly improve patient outcomes.”
ICON Launches ICONIKICON launched ICONIK, an integrated technology solution that provides a single view of study information to both sponsor and CRO teams anytime, anywhere.
ICONIK provides immediate knowledge to study teams by allowing near real-time access to study performance metrics, critical safety and efficacy data, and analysis of this data. ICONIK consolidates and standardizes data from multiple sources, including CTMS, EDC, IVR and ePRO, and combines the data with analytical, reporting and visualization tools to provide a singe view of study information. Both CRO and sponsor teams can access study information and trends at anytime from a secure, web-based interface. A 21CFR compliant solution, ICONIK enables sponsors to more easily meet regulatory requirements by providing an online, end-to-end audit trail of study data for FDA submissions and post-submission queries, according to the company.
As part of the ICONIK solution, ICON is the first CRO to fully deploy the Oracle Life Sciences Data Hub, which will form the backbone of the ICONIK Clinical Data Repository. Oracle Life Sciences Data Hub is a validated and secure repository that pools clinical and non-clinical data from multiple sources into a single environment where it can be analyzed and reported to support decision-making.
“Clients are looking to make better informed and faster decisions and need real-time access to safety and performance data, rather than ad hoc programmed output, to make these decisions,” said Mike McGrath, senior vice president, Information Technology at ICON. “ICONIK provides true data transparency and visualization of all study data, from site selection through to database lock and enables clients to view critical safety and efficacy trends as they emerge.”
More info: www.iconplc.com
QUMAS Offers New Compliance PlatformQUMAS featured its new compliance platform that provides a closed-loop compliance solution combining all of the elements of a comprehensive regulatory compliance program, on one platform. It delivers traditional capabilities around document and process management, but also presents these through a unified user interface, with just-in-time learning management, and consolidated reporting and dashboards, all driving regulatory compliance and ultimately delivering better business performance, according to the company.
“Life sciences firms are realizing that managing regulatory compliance with a myriad of point solutions is highly inefficient and costly,” noted Kevin O’Leary, chief executive officer for QUMAS. “The QUMAS Compliance Platform is a scalable solution that offers a full set of best practice configurations to address all of the compliance requirements of an organization.”
Study Identifies CRO Assets in Kansas City RegionAccording to a new study released at DIA, the greater Kansas City region is home to a significant cluster of CROs and contract service providers with more than $1 billion in annual revenue.
The study was commissioned through a partnership consisting of the Kansas Bioscience Authority, the Kansas Bio Organization, the Kansas City Area Life Sciences Institute and the Kansas City Area Development Council. The study also found that the Kansas City region is home to approximately 70 CROs and CSPs employing more than 9,000 people.
“Working with our regional partners, we commissioned this study because we knew there was a wealth of contract research and service activity in the region,” said David Vranicar, interim president and chief executive officer of the Kansas Bioscience Authority, “but it was surprising – even to those of us who know the space well – to learn that this is an industry that exceeds one billion dollars in revenue locally. Of equal significance is the diversity of the region’s CRO and contract service provider offerings, spanning every stage of drug development required to identify and bring new drugs and devices to market.”
GlobalCare Expands Into Russia and IndiaGlobalCare Clinical Trials, Ltd. announced its expansion into India and Russia. GlobalCare provides selected clinical study visits in the home or alternate settings for study patients to support Phase I-IV trials in a variety of therapeutic areas, genomics and personalized medicine. These services are aimed at reduction in subject recruitment time and an increase in subject retention.
Some regional advantages include Russia’s rapid enrollment rates – three to 20 times faster than in North America and Western Europe. And, India has specialty hospitals and facilities, significant numbers of GCP-trained clinicians, and a large English-proficient workforce. Additionally, the vast number of medically eligible patients in India also provides a large pool of patients in many disease areas including diabetes and cancer.
“GlobalCare can cost-effectively deliver high quality, flexible clinical trial services to these populations in convenient settings like their home, office or alternate setting,” said Gail Adinamis, founder and chief executive officer of GlobalCare. “As the industry demand for optimized study logistics grows globally, we will continue to expand our network to keep pace with these needs. Equally important for the success of a program is understanding a country’s culture and logistics, which our locally based country coordinators provide to successfully navigate newer territories for our clients,” added Ms. Adinamis.
With this expansion into India and Russia, GlobalCare now provides services in more than 25 countries including the U.S., Canada, Israel, Australia and countries in Latin America and throughout Europe.
PharmaNet’s Bioanalytical Lab Recognized by Standards CouncilPharmaNet Development Group’s bioanalytical lab in Quebec has received formal recognition from the Standards Council of Canada (SCC) for its compliance with the Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice (GLP). The OECD, an inter-governmental organization comprising 34 countries in North America, Europe and Asia, pursues the international harmonization of test methods and good laboratory practices.
“After an in-depth review by a four-person inspection team, the Standards Council of Canada awarded us with official recognition of GLP compliance, acknowledging the premier level of quality and compliance maintained in our laboratory,” said Tony Jones, executive director, Quality Assurance and Compliance.
PharmaNet’s labs offer complete bioanalytical services for small and large molecules across the continuum of drug development. The company’s other lab in Princeton, NJ, is also GLP-compliant.