ChemBioOffice Enterprise
ChemBioOffice Enterprise is a comprehensive knowledge management and informatics solution, covering electronic notebooks, biological screening and chemical registration over your intranet. ChemBioOffice Enterprise Ultra includes E-Notebook for record keeping, BioAssay for low and high throughput screening with integrated plate inventory, BioSAR for SAR reports, Registration System, Inventory for reagents and biologicals, and a one year subscription to the ChemACX database of available chemicals. Technologies include ChemDraw ActiveX and Oracle Cartridge.
Click here to explore the ChemBioOffice Enterprise integrated suite.
Research and Discovery
Researchers can record and share their experimental information using E-Notebook, while protecting intellectual property with digital signatures and 21 CFR Part 11 compliance. They can design both single experiments or design combinatorial libraries of compounds. They can find and purchase reagents in ChemACX database, store and use them from Inventory, record newly made compounds within a proprietary Registration system, record the results in BioAssay, analyze the results with BioViz, and generate reports linking activity and structure with BioSAR.
Virtually every aspect of discovery, from synthesis planning, library enumeration, reagent selection, primary and secondary screening, in vivo testing, through to analysis of results and reporting is covered by this integrated application suite.
Development and Testing
Building on productivity software, CambridgeSoft created enterprise applications to meet the needs of an ever expanding research and development community that relies on data sharing across scientific disciplines, research campuses, and even oceans as globalization has increased demands. Since the software takes advantage of the latest web based technologies, it is deployed readily throughout a research and development organization. Using the integrated suite, scientific teams are well armed to solve the daily challenges of development. These teams include scientists who scale up and design manufacturing procedures, toxicologists who determine the metabolic fate of drug candidates, formulation scientists who determine drug dosing and delivery systems, as well as many others.
Trials
A suitable drug candidate is one that has the desired activity to provide disease therapy while meeting drug safety requirements, can be manufactured in a cost effective and reproducible fashion under 21 CFR Part 11 and Good Manufacturing Processes (GMP) guidelines, and is stable under normal formulation and storage conditions. With a drug candidate in hand, the final challenge is to determine safety and efficacy, beyond the laboratory in a patient population.
Manufacturing
Manufacturing requires the transfer of data and batch process records from the pilot plant studies using Inventory, E-Notebook, and Registration systems under Good Laboratory and Manufacturing Processes (GxP).
The handling of materials, including chain of custody requirements, material documentation, material workflow, such as availability states and recertification dates, are tracked and handled by the system.
These systems meet the requirements and provide the basis to manage materials and records during clinical trials. Clinicians can design and record results from protocols, and all of these web based software systems provide the access required by clinicians who are removed from the sponsoring company.
