Pharmaceutical Software Vendor / Product Summary

Visual Edge Consulting & Software, LLC has implemented and/or integrated with the following software products (please see disclaimer):

Vendor Product Vendor Claim
CIMCON Software Inc.
eInfotree Excel Plug-In "The eInfotree™ Digital Compliance™ Platform from CIMCON Software, Inc. is the life science industry's first and only available solution that provides 21 CFR Part 11 compliance for Excel spreadsheets, Databases and Files/Documents in a single system. The eInfotree Desktop Series Excel Plug-in Solution brings Excel workbooks into compliance with 21 CFR Part 11 using only your computer, Microsoft Windows and Microsoft Office."
DiscoveryLink "How can you transform massive quantities of highly complex, constantly-changing data from a variety of data sources--into knowledge? This is one of your biggest challenges. To remain competitive, you must find a way to meet this challenge--to simplify the discovery process and bring more products to market faster. IBM DiscoveryLink® can help by enabling cross-queries of multiple data sources in multiple formats."
Provantis Provantis™ is the industry-leading software system developed for companies engaged in non-clinical safety evaluation studies. The market leader in its field Provantis™ is in use at over 70 sites worldwide. The advanced flexibility of the Provantis™ system means that it is ideal for both multi-national corporations and smaller organizations who may predominantly be conducting investigational studies.
Impact Business Information Solutions Inc.
IBISecg "IBISecg is a secure, scalable, Web-based, enterprise solution that can play a key role in your long-term ECG data management strategy."
TFR/Tox "TFR/Tox is an integrated data management system for management of preclinical toxicology research. It is particularly suited to the needs of reproductive toxicology and teratology, as it was designed with these uses in mind, but it's also an effective tool for general toxicology. It will also prove quite beneficial to contract research organizations, as it is set up to be able to handle an unlimited number of customers' data separately and securely."
Sapphire™ LIMS "LabVantage's Sapphire™ LIMS helps laboratories increase productivity, lower operating costs, and improve quality. Sapphire™'s configurable process automation and communication capabilities enable laboratories to model their business-specific workflows, seamlessly integrate with robots and analytical instruments, effectively manage samples, and meet government regulations. Sapphire™'s browser-based architecture provides users, both internal and external to the laboratory, with the ability to access their Sapphire™ LIMS from virtually any Internet access device. It offers the functionality, flexibility, and scalability that will meet customers' needs both today and in the future."
Octagon Research Solutions, Inc.
ViewPoint "Octagon’s process management solution (ViewPointTM) provides a global view of your deliverables and processes in order to measure and improve performance throughout the entire clinical research and drug development lifecycle. Unlike other solutions, ViewPoint integrates all the disparate systems and processes to truly optimize the submission process. ViewPoint empowers clients to autonomously implement our holistic approach (VantagePointSM) to achieve fully-integrated functionality across departments. ViewPoint, provides on-demand management views of critical process issues and enables scenario-driven modeling and analytics for proactive process management. "
Clinical A clinical management solution that enables companies to standardize and control data definitions and data usage across a global operation.
   Remote Data Capture "The Oracle Clinical Remote Data Capture application is a clinical study tool for on-site data entry and data management. It allows study site users to read from and write to the sponsor’s database where the clinical data is collected. This provides immediate, direct data transfer to the database, as well as immediate detection of discrepancies, enabling site coordinators to resolve and manage discrepancies in a timely manner."
Pharsight Corporation
Trial Simulator "A new, more powerful, more efficient approach to  computer-assisted trial design (CATD),  Pharsight Trial Simulator (PTS), balances ease-of-use with powerful technology (patent-pending) for defining and testing interactive drug models, defining and communicating study design attributes, and performing statistical and sensitivity analysis using graphical summaries.  The Pharsight Trial Simulator, enables the entire clinical development team to improve access to existing scientific knowledge, communicate and test ideas, and plan relevant, effective trials for every phase of clinical drug testing. Companies can anticipate risks and preview the range of expected results before R&D dollars are committed to further development of a drug, and human subjects are exposed to experimental therapies"
  WinNonLin "WinNonlin® has quickly become the new industry standard in PK, PD, and Noncompartmental Analysis. Its intuitive interface and flexible framework facilitate the use of this powerful application and provide seamless interfacing with other software and hardware."
Master Reference Manager "With Siperian Master Reference Manager, your IT team can consolidate and reconcile multiple data sources via a rules-based system. Siperian’s MRM builds and maintains a reliable, trustworthy foundation of customer reference data. In the Master Reference Store, customer data is easily managed at a record or cell level, and is readily extended to additional sources without writing any code. The Master Reference Store delivers the best version of truth for each customer to any operational or analytical application. This improves the reliability of data used for customer interactions, business analyses, and regulatory compliance. The Master Reference Manager has a Data Steward Console that provides business users complete visibility and control into the data, its origins, and any changes over time."
Thermo Electron Corporation
EP Series "EP Series™ is the world's first commercially available database system for the centralized GLP-compliant management, analysis, simulation and reporting of PK/PD data in drug development. The system was developed in conjunction with several major pharmaceutical companies to ensure it meets the real-world needs of Scientists, Quality Assurance personnel, and Information Technology staff in pharmaceutical, biotech and other research organizations. The EP Series enables research organizations to streamline data handling and integrate information into Enterprise-Wide Knowledge."
  Kinetica "Kinetica™ is a powerful, industry-standard pharmacokinetic-pharmacodynamic (PK/PD) application for non-compartmental, fitting, simulation, population PK/PD and reporting. With an intuitive point-and-click graphical interface, Kinetica™ facilitates data analysis and reporting in a structured yet flexible, easy-to-automate environment. A unique non-compartmental assistant technology and a multitude of different standard and advanced scientific methods offer fast high-throughput data analysis for clinical, preclinical, discovery, drug metabolism and drug delivery settings."
  Watson LIMS "The Watson™ LIMS system is a highly specialized protocol-driven Laboratory Information Management System specifically designed to support DMPK/Bioanalytical studies in drug development. The system has been developed in conjunction with major pharmaceutical companies to accelerate bioanalysis and sample management in drug development. Watson is installed in 10 of the top 10 global pharmaceutical organizations, and is widely used in leading biotechnology and contract research organizations worldwide."
  Nautilus "Nautilus LIMS is designed for the unique requirements of R&D labs. A flexible and intuitive interface graphically maps laboratory workflows to meet the needs of even the most dynamic environments. Full functionality for plate handling and manipulation can be used to track plate movement and genealogy, while standard integration functionality allows data to be easily imported without coding from a variety of analytical instruments."
  SampleManager "SampleManager is designed for organizations seeking a standard LIMS for all their labs. With proven, dependable technology at its core, the SampleManager solution ensures predictable deployments and consistent performance. SampleManager can be implemented to support both local and global lab deployments, is scalable for a large user base and available in multiple languages. The product integrates with other applications and instruments, providing a foundation for a complete lab automation solution."
Waters Corporation
Q-DIS/R Q-DIS/R™ - is the comprehensive system that combines analytical workflow and information management with integrated instrument control and secure raw data archiving.
  NuGenesis Scientific Data Management System (SDMS) "The Web-based NuGenesis Scientific Data Management System (SDMS) platform provides a foundation for scientific data preservation and for integrating the collaborative flow of information throughout the organization. Featuring application-independent architecture, NuGenesis SDMS utilizes unique “file and print capture” technology that consolidates and manages critical scientific information generated from any instrument or application."
  "Interoperable NuGenesis SDMS can exchange data with e-lab notebooks, LIMS, EDMS or other common systems. Finding your data takes just seconds; it’s also easy to send selected data to business applications to share with collaborators anywhere in the world. You can even include traceable hyperlinks to the source data."
Wimmer Systems, LLC
Data Compliance System "21 CFR 11 Compliance for Microsoft® Excel - Wimmer Systems remains the industry leader in providing a commercial 21CFR11 compliance solution specifically for Excel. Since 2001, our innovative approach has provided companies with a low-cost, low-overhead system that puts the technical controls required by Part 11 on their spreadsheets while maintaining the power and flexibility of Excel. Our DaCS™ software features secure login, cell-level audit trails, electronic signatures, and tamper detection. "
Xybion Corporation
PATH/TOX System "Xybion's PATH/TOX SYSTEM is the most comprehensive Preclinical Data Management System available, integrating all laboratory activities including In-Life Toxicology, Reproductive Toxicology and Teratology, Clinical Pathology, Necropsy, Histopathology and Compound Management, in a protocol-controlled environment. The system is widely used throughout the United States, Europe, and Japan, managing data and generating reports for companies in every segment of the pharmaceutical and chemical research community."

Visual Edge Consuting & Software, LLC Product Information Disclaimer
Although the information and recommendations for the products listed are presented in good faith and believed to be correct, Visual Edge Consulting & Software, LLC ("VECS") makes no representations or warranties as to the completeness or accuracy of the information.

Information is supplied upon the condition that the persons receiving same will make their own determination as to its suitability for their purposes prior to use. In no event will VECS be responsible for damages of any nature whatsoever resulting from the use of or reliance upon information from this site or the products to which the information refers.

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