Experienced Medical Directors ensure continuous study supervision and liaison with sponsors and regulators, supervise pharmacovigilance to detect safety signals and dose-limiting toxicities, provide authorization for subsequent dose cohorts, review medical coding and reporting, and all other medical services critical for a safe and successful study.
Syreon maintains a meticulous suite of quality systems to ensure the highest professional performance in every aspect of operations. Our extensive Standard Operating Procedures and intensive personnel training system ensure that each facet of research is fully integrated with sponsor operating procedures and Canadian, US and international regulatory requirements.
Expert project managers work closely with each sponsor to identify precise objectives, timelines and outcomes; support trial committees; track communications, timelines, milestones and operations; and ensure that studies are conducted on time, within budget, and in accordance with all relevant regulatory guidelines.
Syreon streamlines site management, drawing on our international networks of expert academic and community investigators to ensure rapid commitment, contracting, IRB approval, training and set-up, with continuous support to speed the learning curve, improve protocol adherence and data accuracy, and minimize time and costs.
Syreon offers flexible integration of all forms of data input via its sophisticated and 21CFR part 11 fully compliant ClinStream EDC and ePRO systems. These provide full capabilities from direct single-point entry to the automated upload, processing, integration and on-line analysis of complex multidimensional institutional data.
Select full or risk-based strategies for clinical monitoring to ensure efficient trial management and high data quality. Incorporate sophisticated data-driven strategies to identify site risks, performance failures, and potential trial hazards in advance to ensure optimal quality and safety at lowest cost.
Enjoy complete support for all trials from clinical trial design to project simulation, data visualization and modeling, interim and formal trial analysis, DSMB support, and presentation of results to regulatory agencies and other bodies with a full complement of pharmacokinetic, dynamic, genomic, clinical and economic analyses.
Our expert editorial team provides all study documents, clinical reports, conference presentations and manuscripts, coordinating rigorous review by investigators, and enabling the results of the research study to be presented and published quickly in high-profile scientific journals.