Solution Providers
Scientific Data Management Systems
To add a solution provider, go to our Submission Page
Waters Informatics
Waters is committed to providing powerful software solutions for
scientific data management, network integration, compliance management
and laboratory productivity. Our informatics solutions are in active use
within leading pharmaceutical, biotech and chemical organizations as
well as within government and academic institutions.
Amartus - TargetWatch
TargetWatch™ SDMS features:
- Providing a single secure location for all project related data
- Improving access to project data for collaborators and clients
- Supporting storage and distribution of data from multiple sources
- Improving communication channels among team members especially those
off-site
- Automating document handling capabilities to facilitate access to
procedures and safety documentation
- Protecting Intellectual Property
Accelerated Technology Laboratories, Inc.
ATL, Inc. pioneered Windows-based Laboratory Information Management
Systems(LIMS)with SQL Server and Oracle data management solutions. ATL
offers the Sample Master® LIMS product line in many industries such as
government, environmental, water and wastewater, R&D, manufacturing and
public health. ATL prides itself on providing affordable, user friendly,
state of the art LIMS and laboratory automation solutions. ATL is also a
certified Microsoft Solution Provider and ISO 9001:2000 Certified.
Autoscribe Ltd.
Autoscribe Limited is a world leader in the development and supply of
successful software solutions and services for LIMS and the scientific
laboratory and business markets. We pioneered the use of innovative
configuration tools within the LIMS market and offer a wide portfolio of
products and services including validation, LIMS, sample tracking, ICMS,
stability testing, customer complaints, scientific data management,
ISO9000 training records management and resource planning for any
industry.
Beckman
Coulter
Beckman Coulter LAO provides Laboratory Information Management Systems (LIMS)
for scientific laboratories. LabManager iLIMS is installed in 1600
laboratories meeting the highest quality and most stringent FDA 21CFR11
regulatory requirements in areas that include QA/QC and Analytical
Services.
Coffey Analysis
Coffey Analysis provides automation software for drug discovery and HTS.
Our Automation Explorer(TM) software is fully 21 CFR Part 11-compliant,
including biometric identification and automated tracking of all data
modifications.
CytoGenomics Inc
Cytogenomics Inc is a Missouri, US-based bioinformatics company with sales office in Tokyo, Japan and a development center in Bangalore-India. In addition to its own team of biologists, Cytogenomics has partnered with other companies in Life Sciences segment in order to provide leading edge solutions in bioinformatics.CytoGenomics has entered into sales and marketing collaborations with system-integrators and value-added resellers across the globe to reach its solutions to the end-user.
Innovation to the core
Datatrak
DATATRAK International is the leading and most experienced application
service provider (ASP) in the electronic data capture (EDC) industry.
DATATRAK EDC(tm) has been successfully implemented in more than 60
clinical trials, in 45 countries, involving thousands of sites.
Sponsor-generated metrics using DATATRAK EDC(tm) have demonstrated a 30%
reduction in clinical trial duration, a 40% efficiency in time to locked
database, and an 86% reduction in Query rate compared to conventional
paper processes. DATATRAK EDC(tm) can uniquely be deployed worldwide in
either a distributed platform using laptop computers, or in a centralized
server "thin client" environment using the Internet.
E-Flexion
A
revolutionary, powerful monitoring tool, E-Flexion fully automates the
tasks of process data management. In seconds, E-Flexion collects, stores,
analyzes, and delivers to the desktop comprehensive, secure information
about your manufacturing processes. Freed from manual data collection and
analysis, your people can focus on quality improvement, empowered with
knowledge for more effective decision making.
Fieldworker
Products Limited
FieldWorker is 21 CFR compliant application for data capture/reporting
wants. Clients receive complete knowledge transfer and are self
sufficient to use platform tools to configure/deploy all manner of
e-forms. Data is sync. into existing systems. Incorporating e-signatures,time
stamps, digital image, bar code, RFID, GPS Map, instrument reads into
secure reporter-unique records. Live demo
http://www.fieldworker.com/web_demo.html
This technology is perfect for organizations conducting 3rd party
clinical trials because trial specific applications can be configured
and distributed to only those test sites participating. Same site
participants can be sent different applications, and still be part of
the common communicating platform.
Icalis
Data Systems Ltd.
Icalis Data Systems Ltd develops and markets software for instrument
control and data processing in the field of Tablet Dissolution Testing for
the Pharmaceutical industry. The company provides solutions that integrate
dissolution baths, spectrophotometers and other laboratory instrumentation
with professional data management software meeting all requirements of
21CFR Part 11. This software provides companies with an 'Open System
Architecture' with highly configurable methodologies that incorporates
instrumentation from most manufacturers.
Information Analysis
Corporation
MEDLOG is a Windows based clinical data management system. It has audit
trails, password access levels, exception tracking and double data entry
verification. It does not require database programming - a plus for
smaller organizations. MEDLOG has statistical analyses, time-oriented
retrieval, a report writer, and export to SAS and Excel. MEDLOG is now at
over 100 sites. Price: $4-20,000.
InnaPhase
InnaPhase's Enterprise Pharmacology series, an Oracle
based, enterprise system for the analysis, management and reporting of
non-clinical and clinical data provides clients with a solution that can
meet 21 CFR Part 11 and GxP guidelines. Full system security, full
electronic audit trail, and complete data traceability from entry into the
system to report generation, eliminates manual data transfer and open file
intermediates.
Instem
Instem provides 21CFR11 compliant solutions for companies engaged in
non-clinical safety evaluation studies, incorporating the industry-leading
toxicology/pathology software system, Provantis, and the unique toxicology
resource planning system, TRP.
ISIS
BioComp
ISIS BioComp provides TFR/Tox, a comprehensive, integrated, Oracle-based
system for the collection, management, and evaluation of preclinical data
generated by teratology, fertility, reproductive, and general toxicology
studies. It is mature, documented, validated, flexible, and easily
customized to users' requirements. Developed with GLP compliance in mind,
it conforms to requirements of 21 CFR 11 and is easily validated with aids
we supply.
LABCAT
LABCAT offers a complete suite of software for the
pharmacology/toxicology research community. We specialize in data
collection and analysis products for the pre-clinical phase of drug
development. For over two decades, LABCAT has been helping to accelerate
the discovery and development of drugs and agrochemical products in
laboratories and research facilities throughout the world. We design our
products specifically to work in a GLP and 21 CFR Part 11 environment,
providing comprehensive security, electronic signatures and audit trails.
Labcon Engineering
Labcon Engineering offers services to assist you in achieving compliance
with 21cfr11, next to interface software for being compliance with
regulations while transferring data from instruments to LIMS. See our
website for more information
LabLogic
Systems
LabLogic Systems provide LIMS solutions for ADME and DMPK/Bioanalytical
protocol driven studies through our DEBRA and WATSON systems. Our fully
configurable security with tools to allow system and project defined
electronic signatures combined with comprehensive auditing, direct data
transfer from laboratory equipment and instrumentation, for example with
Sciex Analyst software, enable the user to have a compliant and validated
solution.
Labnotes
Convert your paper-based laboratory data recording systems into electronic
format with LabnotesTM.
Designed to enhance laboratory efficiency and to facilitate compliance
with 21 CFR Part 11, the package incorporates the highest standards of
security and allows data to be interrogated, tabulated, checked, approved,
stored and archived electronically. The application runs efficiently
alongside existing LIMS systems, includes a scheduling option, and
includes a suite of tried and tested forms.
LABTrack
LABTrack is the first Legal electronic lab notebook. Introduced in 1996,
it was first commercial ELN to offer Electronic Signature (21 CFR 11) and
the first and only ELN that creates a notebook that is recognized as legal
evidence in a court of law and before the Patent & Trademark Office
(PTO). Visit our site and learn why hundreds of companies
worldwide have implemented LABTrack.
Labtronics.
Incorporating electronic signatures, 100 levels of password protection and
a
full audit trail implementation, LimsLink and LimsLinkCDS from Labtronics
Inc provide the level of security and accountability required to maintain
21
CFR Part 11 compliance while transferring data between instruments and
LIMS.
Used by more LIMS vendors than any other interfacing software, LimsLink
and
LimsLinkCDS set the standards for Instrument to LIMS interfacing.
L.I.M.S. (USA) Inc.
StarLIMS is a powerful, full-featured, highly extensible and scalable
laboratory information management system. L.I.M.S.’ primary goal has been
to deliver leading edge, flexible and easy-to-use, collaborative LIMS
solutions to organizations worldwide, comprising corporate, government,
municipal, and private laboratories, within the chemical, clinical,
environmental, food, forensics, petrochemical and pharmaceutical
industries.
Pinnacle Solutions
Pinnacle Solutions, a provider of business intelligence solutions for
firms in highly regulated industries, offers Modero for managing and
controlling use of analytic software objects (e.g. SAS programs).
Utilizing a company’s existing content management systems, Modero provides
a compliant, secure environment for accessing, creating, and executing
multiple analysis projects in multiple operating environments. Modero
delivers version control, audit trails, and analysis output traceability.
Process Analysis &
Automation Ltd
Solution11 XL provides a complete 21CFR11 environment for Microsoft
Excel. Provenance is provided for all Quality workbooks and templates
through a secure encrypted audit trail, electronic signatures and user
management system. The product is scaleable, for multiple users on a
network, or on a laptop, allowing users to migrate documents without
compromising security.
PAA also market 'Solution11 Toolkit' which allows software developers to
secure their applications in a 21CFR11 wrapper.
QED
Solutions
QED Solutions develops pioneering software solutions for drug safety
management that combine innovative algorithms and state-of-the-art safety
surveillance tools to facilitate the identification, analysis and
validation of signals leading to the early detection of possible drug
safety issues. Access to QED's cleaned and mapped FDA data (or World data
- to be released in 2002) enhances your ability to monitor and understand
patterns of drug or molecule behavior reported around the world to gain
the earliest market intelligence.
Scimagix, Inc.
Scimagix™ Inc., is the pioneer of enterprise image informatics solutions
for pharmaceutical and biotechnology research and development. Image
informatics is the integration of valuable image and non-image data into
an enterprise-wide, multi-site software platform allowing scientists to
search, mine and analyze results. SIMS is the only web based image
informatics solution that enables companies to ensure that image data
files meet with regulatory standards, including GxP, Part 11 and CNIL.
Tessella Support Services plc
Tessella is one of the leading developers of bespoke software applications
for scientific data management. Tessella can help you develop a
streamlined data pipeline tailored to your organization’s needs, using
off-the-shelf building blocks and custom developed code as required. The
improved efficiency and effectiveness gained may give you that all
important “edge” over your competitors.
Velquest
ePMC: A Fully
Integrated Approach to "Paperless" GMP/GLP Compliance Platform
VelQuest Corporation has developed a completely integrated ePMC™
(Electronic Process Management and Compliance) platform. VelQuest's ePMC
technology provides a fully validated, paperless approach to data
acquisition, documentation, storage and retrieval for use in new product
submissions, product releases, stability testing, quality assurance and
management analysis.
WireWorks West
FermWorks 2™, the fermentation and cell culture management application
from WireWorks West, automates process development and accelerates the
commercialization of new biotherapeutics.
FermWorks currently runs in process development laboratories and pilot
plants at major pharmaceutical companies.
FermWorks complies with FDA 21 CFR Part 11 regulations and conforms to
ASTM Committee E55 (PAT) initiative.
Xybion
Medical Systems
Xybion Medical Systems develops 21CFR11 compliant, comprehensive and
well-integrated software solutions for Pre-clinical Data Management.
Xybion’s PATH/TOX SYSTEM is a suite of tightly integrated modules that
addresses all aspects of pre-clinical data acquisition, management and
reporting.
