Aris Global, a leading provider of software solutions for the life
sciences industry, today announced at Clinical Trials Congress the
release of agClinical(TM) and agClinical NW(TM), two comprehensive
solutions for clinical trials management where processes supporting
clinical trial activities are not just tracked, they are executed in
accordance with international ICH GCP standards. agClinical, designed
for the smaller life sciences company, provides core trial management
functionality and offers easy integration with multiple clinical
applications, while agClinical NW helps large companies perform and
manage end-to-end clinical trial processes more effectively and
efficiently than other available clinical trials management system
(CTMS) offerings.
"Execution versus tracking, and support of the entire clinical
community activities are what differentiate agClinical and agClinical
NW from other CTMS applications on the market," said Simon Sparkes,
vice president, corporate strategy, Aris Global. "In particular,
agClinical NW not only provides the core capabilities agClinical
provides, it goes much further in providing process support for
clinical supplies, investigator budgets and payments, and investigator
self-registration. With these solutions, we´ve brought the entire
research community together and enabled communication and
collaboration across the full spectrum of trial activities."
"Aris Global´s integrated CTMS solution is leading the market by
moving to the next level in the management of clinical trials," said
Lorraine D. Ellis, President and CEO, Research Dynamics, a Rochester,
NY-based CRO. "Using this CTMS solution to perform daily trial
management tasks will give users real-time, actionable information and
automate processes that replace paper-intensive efforts. It responds
to the ´what´s-in-it-for-me´ question for users who are just entering
information into a traditional CTMS database but not gaining any
productivity or information advantage."
Core CTMS Activities
agClinical offers a centralized platform for integrating,
executing and managing the comprehensive range of global clinical
research programs. From protocol design to site recruitment to last
subject visit to final report, agClinical enables companies to plan,
track and control tasks related to clinical trial management. Sponsors
can ensure clinical trials are designed, conducted, recorded and
reported in accordance with ICH GCP standards and keep global trials
on track, on budget and on time.
SAP AG has made a minority investment in Aris Global Holdings LLC
through its global SAP NetWeaver(R) Fund, which underscores SAP´s
commitment to fuel the development of innovative solutions built on
the SAP NetWeaver platform. SAP and Aris Global have cooperated
through the fund in the co-innovation of agClinical NW. The companies
worked together to engage in customer advisory councils to uncover and
define requirements, develop roadmaps, as well as provide Aris Global
with support of its new application.
agClinical NW is the only CTMS that combines clinical operations,
clinical supplies and accounting functionalities. It is built on the
"enter data once, re-use multiple times" model and provides role-based
access for the various user roles active in clinical trials. Users
have access to exactly the data they need for their daily work and
decision making, irrespectively of which system the data originates in
and/or from. agClinical NW supports investigator self services,
automates investigator payment processes, increases supplies
accountability accuracy and timeliness, and facilitates tracking,
documentation and reporting of clinical trials.
"Aris Global and SAP have leveraged their life sciences expertise,
application components, and a unique portal composite approach to
co-innovate a next-generation CTMS that supports the collaborative
business model that today´s trial sponsors work under," said John
Orley, product manager, Clinical Management Applications, Aris Global.
"Today´s sponsor must manage a study across its lifecycle, involving
numerous processes, tasks, documents, applications and a multitude of
internal and external constituencies located across the globe.
agClinical and agClinical NW support this collaborative business
model, resulting in significant improvements in quality, productivity
and compliance, risk mitigation and management."
Unique Investigator Portal
According to Sparkes, "Investigator relationship management is
becoming important as the means for improving study efficiency and
productivity, especially in light of industry research that shows
sponsors are increasingly conducting trials involving foreign-based
investigators from across the globe. We´ve introduced a unique concept
of an investigator portal that delivers powerful investigator
relationship management capabilities for identification,
qualification, and selection."
Delivers Finance and Clinical Supplies Management
agClinical NW delivers end-to-end support for investigator grant
creation, incurred expense approval and investigator/site payment
processing to ensure adequate processing, tracking, control and
reporting of planned and actual study expenses.
The new product also supports the processing of supply requests,
shipments, receipts and usage. Transactions allow real-time tracking,
documentation and accountability for the entire protocol and
individual countries, sites and subjects.
Availability
agClinical 2.0 and agClinical NW 2.0 are available now.
About Aris Global
Aris Global (www.arisglobal.com) is a leading provider of
integrated software solutions for pharmacovigilance and safety,
regulatory affairs, clinical research and medical information. More
than 150 life science customers use the company´s advanced solutions
for maintaining regulatory compliance, managing and mitigating risk,
improving operational efficiency and easily sharing information on a
global basis.
agClinical, agClinical NW, and ARISg are trademarks of Aris Global
LLC.
SAP, SAP NetWeaver and other SAP products and services mentioned
herein as well as their respective logos are trademarks or registered
trademarks of SAP AG in Germany and in several other countries all
over the world.
Other product or company names mentioned herein are the trademarks
of their respective owners.