[September 03, 2015] |
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SynteractHCR Enhances Technology Offerings for Clients Through Upgrades, Certifications and Additions
SynteractHCR,
an international contract research organization, has recently completed
a series of technology upgrades and certifications, in addition to
adding some new tools to its tech arsenal. With these technology
updates, SynteractHCR can provide increasingly greater efficiencies to
its biopharmaceutical clients. In combination, these improvements mean
SynteractHCR further optimizes its drug
development services to its clients.
Recent technology enhancements include:
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SAS (News - Alert) Global: In March 2015 SynteractHCR completed its global SAS
initiative, using the latest version, SAS®
9.4. Programs work identically no matter where in the world
programmers are located and clients receive consistent performance of
their output.
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Global Feasibility and Investigator Grant Assessment Capabilities:
Also in March 2015, to increase the accuracy and efficiency of site
selection and feasibility analysis, SynteractHCR incorporated the use
of IMS Health Tool. This provides customers a more granular level of
detail and offers data-driven recommendations that facilitate more
accurate project budgets and plans upfront.
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Electronic Common Technical Document (eCTD): In April 2015, the
company enhanced its global
medical and regulatory affairs service offering by providing
comprehensive Electronic Common Technical Document (eCTD) services to
support electronic submission to regulatory authorities. Using
in-house, experienced staff, SynteractHCR offers all aspects of
electronic document preparation, document management, eCTD publishing,
submission management and Regulatory Authority submission. Committed
to improving the knowledge base of its small- to-mid-sized and
emerging clients, SynteractHCR walks them through the process,
explains requirements, and provides guidance.
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Adaptive Software: In June 2015, SynteractHCR updated to
Cytel's East® 6.3 for Adaptive Design and integrated nQuery
Advisor. These tools enhance the CRO's ability to offer sample size
and power calculations, and group sequential designs or fixed adaptive
design. With East, trial monitoring can handle on-going accrual and
event count update, as well as calculate the stopping boundaries,
futility boundaries, and conditional power for interim analyses.
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Pharmacovigilance Systems: SynteractHCR, committed to continual
improvement of its pharmacovigilance systems, has an ongoing effort to
apply Oracle (News - Alert)® application patches to meet changing
regulatory requirements and apply security/bug fixes. In August 2015,
SynteractHCR became a gold level member in the Oracle
Partner Network (OPN specialized) as an Argus
hosting provider. This program provides an easy way for customers to
identify qualified partners in Argus expertise. OPN specialized
training and certification enhances the competency of the SynteractHCR
pharmacovigilance systems group and brings added value to clients for
Argus configuration and application user support. Oracle Argus version
7.0.5 will be released for production use in October 2015 after full
validation.
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EDC Options: With more than two decades of experience providing
customized data
management services, SynteractHCR offers clients different
platforms for cost effective solutions to fit unique project
needs. SynteractHCR is accredited in Medidata
Rave. The company also supports XClinical's
MARVIN, one of the first two EDC software products to be
officially certified for the ODM standard by the CDISC organization.
SynteractHCR also offers the DATATRAK
ONE® Unified Platform, among other EDC platforms.
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CDISC Standards Updates: SynteractHCR has longstanding CDISC
experience since 2004 and continues to be instrumental in defining
industry standards. Using its CDISC offering, SynteractHCR actively
assists clients with their regulatory submissions.
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Interactive Response Technologies: In August 2015, SynteractHCR
had multiple staff members trained on the functionality of the Medidata
Balance applications, process optimization and scope of services.
This accreditation enables SynteractHCR to conduct randomization and
drug trial supply management services using Balance as one of its
technology options.
About SynteractHCR (www.synteracthcr.com)
SynteractHCR is a full-service contract research organization with a
successful two-decade track record supporting biotechnology, medical
device and pharmaceutical companies. SynteractHCR has conducted Phase
I-IV studies on six continents and in more than 60 countries, offering
expertise across multiple therapeutic areas, with notable depth in
oncology, CNS, infectious disease, endocrinology, cardiovascular and
respiratory. With its "Shared Work - Shared Vision" philosophy and ICD+
approach, SynteractHCR provides customized services collaboratively and
cost effectively to provide "Tomorrow's Treatments" to the patients who
need them.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150903006053/en/
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