Phone : 212-584-7888
Fax : 646 375-3183
E-mail : contact@ourielgroup.com

Excellence in patient care has always been and will always be dependent on innovation. But innovation in and of itself may not lead to the successful entrance of a device or pharmaceutical agent into the armamentarium of the clinician. Market entrance depends on the execution of a well-designed clinical trial.

Syntactx |sin-'tak-tiks| is a Contract Research Organization that specializes in medical device trials.  Leveraging long-standing relationships with clinicians/investigators, academic/non-academic institutions, and regulatory agencies; Syntactx partners with industry to develop and execute the research plan.
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Biostatistics Services
Statistical Analysis Plan (SAP)
Statistical Programming
Data Analysis

Biostatistics Services
Creation/Management of DSMB
Evaluation/Reporting of Adverse
Creation/Management of CEC

Site Monitoring
Qualification Visits
Site Initiation
Monitoring Visits
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April, 2012

Syntactx was at the Charing Cross 2012 Congress in London, meeting with our clients, investigators, and regulators.  The cardiovascular medical device arena remains an active area of innovation.   The last year has seen continued iteration of endovascular aneurysm repair devices for both the AAA and thoracic indications.  Lower extremity arterial disease, formerly relegated to open surgical bypass, continues to see design development and clinical testing of new bypass grafts and heparin coatings, novel atherectomy devices, stents, and drug-eluting balloons.  As well, the field has witnessed continued progress  with pharmacologic and mechanical management of acute arterial thrombosis.  Lastly, there has been increased  interest in venous disease, both from the standpoint of new stents designed specifically for use in veins, innovation in the management of acute venous thrombosis, and the percutaneous management of varicose veins.

 

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Syntactx provides a full range of contract research services, from study inception through design and execution

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New focus on post-market studies; rigor should equal that of a PMA.

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Syntactx provides a full range of contract research services, from study inception through design and execution.

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