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Tools for Clinical Trials Professionals
Software release is a one-stop solution for sponsors looking to streamline their clinical trials
Sierra Scientific Software (Emeryville, CA) has released a comprehensive eClinical trials package that enables sponsors to run a trial with a single system, rather than rely on multiple suppliers. The result is a single vendor delivering one integrated, fully interactive, Part 11-compliant solution that captures, archives, and reports on real-time information across the entire enterprise.
With the CRIS v8 Project View feature, integration of information across protocols, compound, regulatory application or indication is possible. The software is customizable since it supports data capture from many sources, from traditional double (or single) data entry, EDC, electronic upload through a variety of formats.
This package, developed through an alliance with Science Application International Corporation (SAIC), integrates with other enterprise applications such as finance and project management and supports all steps in a clinical trial process, including clinical trial management, clinical data management, safety reporting, and investigational materials tracking.
Sierra Scientific Software, Inc., (510) 655-2441, www.sierraware.net.
Label design and production software places a premium on Part 11 compliance
PRISYMID 's (Charlotte, NC) new Medica 5 software release has a one-track mind: meeting FDA's current electronic records and signature requirements, especially 21 CFR Part 11 rules. The software features a highly secure architecture that ensures system integrity and regulatory compliance, and is able to record critical activities and link them to individual users, including time and date stamping.
PRISYMID Medica 5
The new software offers additional bells and whistles, such as management of RFID devices and printed labels. Medica 5 also allows users to extract data from databases, ERP, and MRP systems to design, print, and write RFID labels or RFID tags.
Also new is a special Alert facility that allows monitoring and controlling network printers from a central location. For clinical trial professionals, there is now an additional module: The PRISYM ClinTrial module features randomized and stratified patient lists, as well as study group or center, patient visits, and treatment codes. In addition, label templates can be printed in languages such as Chinese, Cyrillic, or Arabic using Windows True-Type fonts.
PRISYMID , (704) 409-2351, www.prisymidinc.com.
Complete compliance solution offers scalability for small- and medium-sized companies
ComplianceControl (Cheshire, UK) has released a new Oracle-based software suite that offers complete validation and compliance capabilities. ComplianceControl Centre, designed for use in global markets, stores all critical data in a single database. Viewable across an organization, the software suite features scalable access levels.
This software tracks the status of project documents, systems, software, hardware, manufacturing and laboratory equipment. All project risks, changes, minutes, issues, and actions are reported in real time, affording users a comprehensive assessment of compliance.
It can integrate with any proprietary off-the-shelf or in-house-developed systems. As such, the software suite is especially suited for small- and medium-sized organizations due to its scalability. The suite is also attractive to larger life science companies looking for a way to store their validation and compliance data in a single, central repository.
ComplianceControl, (+44) 1606 871113, www.compliance-control.com.