Datafarm Inc., a provider of electronic document publishing solutions and regulatory submissions services for the life sciences industry, announced the availability of eCTDViewer Web Edition 4.0.1, a web-based viewing application that can be used as a primary and/or secondary viewing tool for electronic common technical document review. eCTDViewer Web Edition is scalable and appropriate for companies of all sizes. It makes use of industry-standard web browser applications, such as Microsoft Internet Explorer or Firefox. End-users can be assigned permissions to review eCTD and Non eCTD Electronic (NeES) submissions from anywhere in the world. Read the press release.
Adlib Software, a provider of server-based document conversion and publishing software, and Lorenz Life Sciences, a provider of electronic submissions software, have signed an OEM agreement under the terms of which Lorenz will license and embed Adlib’s ExpressConversion technology into future versions of Lorenz’s docuRender for MS-Word product. The companies expect this technology integration to eliminate submission quality concerns and automate and streamline regulatory publishing with submission-ready PDFs delivered through Lorenz’s docuBridge submission management solution. Read the press release.
Kestrel Consultants has expanded its service offerings to include evaluation of customers’ existing standards use and recommendations to ensure: compliance with CDISC, CDASH, and SDTM structures; consistency and completeness of electronic case report forms, edit checks, databases, and protocol/SAP/CSR templates; and consistency within or across therapy areas or the entire clinical development organization. Kestrel also designs centralized standards management and governance models for customers’ environments to track standards use, and to allow evaluation of standards return on investment.
Sparta Systems Inc., maker of the TrackWise enterprise management software, has furthered its market expansion in Europe with the addition of several new pharmaceutical and biotech companies to its roster of TrackWise customers. These organizations will deploy the company’s TrackWise to support their globally dispersed operations in complying with government regulations, while streamlining overall process efficiency. New European customers recently added to Sparta’s base include: Boehringer Ingelheim; Helsinn Healthcare SA; MED-EL Medical Electronics; ICON; and URSAPHARM ArzneimittelGmbH & Co. KG. Read the press release.