CA-SYNTERACTHCR

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:

• SAS 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.
• 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.
• 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.
• 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.
• Pharmacovigilance Systems : SynteractHCR, committed to continual improvement of its pharmacovigilance systems, has an ongoing effort to apply Oracle^® 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.
• 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.
• 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.
• 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.

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Contact:

for SynteractHCR
Beth Walsh, 760-230-2424
beth@clearpointagency.com

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