Our expert trial design team works closely with each sponsor to develop efficient Phase 1 - Phase IV trials using predictive biomarkers and agile adaptive or surrogate trial models with flexible basket or umbrella designs enabling rapid addition of new cohorts and efficient patient selection through baseline selection or short run-in strategies.
Our experienced Medical Directors ensure continuous study supervision and liaison with sites and sponsors, 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.
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 engagement, commitment and 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 EDC and ePRO systems. These provide database programming, direct single-point entry or automated upload, data processing and queries, coding, integration and in-stream analysis of complex multidimensional institutional data.
Select full, risk-based or centralized strategies supported by our advanced data sciences for your 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.
We provide complete statistical support for all trials from adaptive clinical trial design to project simulation, in-stream 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.
Syreon Research Institute conducts full health economic analysis, cost-effectiveness and cost-utility modeling, creation of value dossiers and strategic pricing presentation across a broad range of acute and chronic disease states. Draw on our health policy expertise to interpret the evidence needed for public health policy-decisions.
Our expert editorial team of senior medical writers provides all necessary 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.