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PerkinElmer Launches Signals for Translational  

 Trending Now:  New cloud-based informatics platform supports complete precision medicine workflow.

PV0116_KarenMaddenPerkinElmer has launched PerkinElmer Signals for Translational, a cloud-based data management, aggregation, and analysis platform for pharmaceutical researchers. This new offering integrates experimental and clinical research data from many sources and relates the data to scientifically meaningful concepts. It also enables support for the complete precision medicine workflow, from data acquisition to biomarker discovery and validation.

Co-developed with top pharmaceutical companies, PerkinElmer Signals for Translational is designed to help researchers easily integrate experimental and clinical data from existing proprietary databases, private and public databases such as GEO and tranSMART, and connect with other enterprise systems.

The new product provides access to data via a simplified user interface and a data model specifically designed to support translational research through the identification and management of biomarkers. It streamlines the sharing of data between pharmaceutical stakeholders and their partners in biotech, academic, and contract research organizations.

“In the past, translational researchers could not intuitively engage with available data, which made searching for and accessing integrated data to identify and characterize biomarkers extremely challenging,” says Karen Madden, president, informatics, PerkinElmer. “This new translational platform’s ability to enhance collaboration and eliminate silos between research and clinical data represents a significant step toward advancing precision medicine, ensuring optimal pairing between patients and drugs, and achieving better outcomes in human health.”

N-of-One Launches PrecisionInsights for Small Gene Panels

PV0116_KathrynKingN-of-One has launched PrecisionInsights, a new clinical interpretation solution specifically designed for small gene panels of 15-20 genes. The solution provides a concise, two-page report for each case providing the most recent clinical and scientific evidence specific to the identified genes and variants in the context of the specific cancer sub type, with cost-effective pricing of $65 per report, with a one-time $1,000 implementation.

“Given our leading knowledgebase containing many thousands of cases and tens of thousands of variants, N-of-One is able to meet this cost challenge for rapid, quality clinical interpretation of small NGS panels with 15-20 genes,” says Chris Cournoyer, CEO of N-of-One. “Organizations need to be able to scale for the growing adoption of NGS testing while maintaining quality, currency of relevant evidence, and very rapid turnaround times.”

Veeva Unveils Study Start-up Solution

Veeva Systems has launched Veeva Vault Study Start-Up, a fully integrated clinical trials study start-up solution that enables life-sciences organizations to manage both the content and the activities associated with activating sites for clinical trials, accelerating time to first patient enrollment, automating manual processes, and delivering seamless interoperability with eTMF.

Vault Study Start-Up brings together site start-up documents and site initiation in a single solution, while providing seamless interoperability with Veeva Vault eTMF. The system also provides advanced capabilities to better manage start-up processes, including a complete, reliable electronic audit trail.

“The life-sciences industry has long struggled with manual and inefficient processes for study start up,” says Kathryn King, VP of Vault Clinical at Veeva. “Existing solutions manage either documents or start-up activities, but never both together. This created significant challenges in identifying and addressing issues during start-up, resulting in longer study durations and impacting overall time to market.”

PV0116_CharlesBoydVeeva has also launched Veeva Vault RIM, a next-generation regulatory information management (RIM) suite. Vault RIM unites submission documents, published dossiers, product registrations, and health authority interactions into a single authoritative source for all regulatory information. The convergence of RIM capabilities in Veeva Vault’s regulatory product suite aligns disconnected regulatory processes worldwide, improving life-sciences companies’ speed, agility, and compliance.

Safe Chain Solutions Offers Track and Trace System

Safe Chain Solutions, a Benchworks company, has released Safe Chain Track and Trace. The system meets the FDA’s requirements, ensuring that Safe Chain is in compliance with the new regulation. Safe Chain has also made modifications to its system that permit customers to track their orders and proof of deliveries from the Safe Chain Track & Trace website.

“This new system exceeds all of the standards that are required by the FDA,” says Charles Boyd, Safe Chain president and partner. “It gives our customers peace of mind knowing that Safe Chain is in compliance, and that they can quickly and easily get the information they need about their transactions. Patient safety is our highest priority and we’re dedicated to this through security and integrity throughout the pharmaceutical supply chain.”

TruTag Technologies Introduces High-Performance Reader

PV0116_KentMansfieldTruTag Technologies has released a new high-performance reader. The handheld optical reader brings satellite imaging technologies to the service of secure product authentication. The system can authenticate in just a few seconds thousands of medicines, electronic components, industrial parts, packaged goods, and other items marked with TruTag microtags.

The microtags are embedded with customizable spectral data that are read by TruTag’s handheld optical readers and can reveal product intelligence.

“This reader is the result of harnessing complex technology for an easy-to-use, handheld format, one that is optimized for decoding an ever-broadening array of products and components needing covert protection from counterfeiting and unauthorized diversion,” says Kent Mansfield, president of TruTag Technologies. (PV)

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