etrials Worldwide, a provider of eClinical software and services that optimize clinical trial management, announced that it has signed a contract with an undisclosed U.S.-based pharmaceutical company. Solutions and services provided by etrials will enable the company to capture, manage, integrate and analyze trial data using etrials’ electronic data capture (EDC), electronic diary (eDiary) and interactive voice/web response (IVR) software solutions. The company will implement etrials’ solutions in three Phase III trials and one Phase II trial related to gastroenterology therapeutics. The trials will include up to 400 sites and 1700 subjects and will require eDiary deployment on up to 1300 mobile devices to capture patient reported outcomes in North America and Eastern Europe.
Pfizer has introduced, to the clinical trial companies, a novel approach to outsourcing. In order to streamline the outsourcing process as much as possible and move from using a traditional mixed model - involving many contract research organizations (CROs) – to a functional service provider (FSP) model – with a handful of carefully chosen niche vendors, Pfizer has shunned the traditional approach to data management outsourcing by slashing its vendors to a handful and standardizing them under the one business model. “All of Pfizer’s data management is now outsourced, along with many other related functions such as data entry, monitoring, statistics and medical writing,” said Thomas Verish, Pfizer’s senior director of Development Operations.
Merge Healthcare, a provider of imaging software and services, announced the release of Fusion RIS/PACS MX(TM), an imaging informatics solution that moves beyond the simple interfacing of RIS and PACS applications designed for multi-facility physician practices and clinics. Fusion RIS/PACS MX promises to help the organizations achieve new efficiencies by blending together the advantages of a RIS (radiology information system) and a PACS (picture archiving and communication system) into a single business and clinical application with a uniquely optimized radiologist workspace environment.
The Digital Pen and Paper technology has been widely and quickly embraced not only in clinical trials but the entire health care sector because it provides such an easy and straight-forward way to capture handwritten text and quickly transmit it from paper to digital formats. Actelion Pharmaceuticals recently presented its application of Digital Pen and Paper technology. Dr. Massimo Raineri, PhD of Actelion, illustrated how Digital Pen and Paper applications developed in collaboration with Actelion and Anoto partners, and digital writing solution developers GM Servizi and Kayentis, could help to accelerate the development of new drugs by making clinical trial processes more efficient and accurate.
Prometrika, a contract research organization serving the biopharmaceutical industry, announced the launch of its clinical trial management services, designed to enhance the current portfolio of Prometrika’s clinical development service offerings. These services will complement its proven expertise in data management, biostatistics and medical writing.
An EDC system data collection for clinical trial investigative sites known as Remote Data Capture Onsite has been recently introduced by Oracle Corp. The interface is designed to accelerate and simplify the collection of clinical data and EDC deployment at investigative sites. The new Oracle interface runs on top of its more familiar product, Oracle Remote Data Capture v4.5.1 for more intuitive data entry and navigation of CRFs.
BioDiscovery, a developer of integrated software solutions for microarray based research, announced the release of GeneDirector 3.5 featuring extended data management support for Affymetrix, Illiumina and Agilent microarray platforms. The new GeneDirector 3.5 provides several major upgrades to the backend data management engine enhancing support for management of the next generation microarray technology.
Ingenuity Systems, a provider of information solutions for the exploration, interpretation, and analysis of experimental data for clinical researchers, introduced Ingenuity Pathways Analysis 5.0 software to offer specific functions for identifying biomarker candidates and characterizing molecular toxicity in a biological context. IPA 5.0 contains an extensive addition of new expert-extracted content from the scientific literature, including new knowledge about diseases, exogenous and endogenous chemicals, and drugs and clinical candidates.
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