Operations
Syreon research teams combine expertise in molecular medicine, biostatistics, clinical therapeutics, economics, health outcomes measurement, and economics to conduct national and international phase I to IV clinical studies. We have extensive experience in all areas of clinical research, extending from developmental therapeutics to formal clinical trials and longitudinal disease-based registry studies in a broad range of therapeutic areas from infectious diseases to complex multisystem disorders. Services encompass study development, site recruitment and operation, data management, on-site monitoring, pharmacovigilance and statistical/scientific analysis, health modeling and reporting. Advanced internet technologies provide immediate and continuous access for authorized research and clinical personnel for study communications or electronic data capture and reporting. Syreon studies are designed to be flexible and scalable and can incorporate from one to many hundreds of participating sites with continuous recording of multidimensional data in real time. Syreon’s international investigator networks and multi-centre studies have enrolled over 35,000 subjects at more than 1000 sites spanning North America, South America, Western Europe, the Middle East, Eastern Europe, South Africa, Australia, Taiwan and China. These programs link Syreon, the study sponsor, and leading site investigators in a continuous process to guide the operation, analysis, presentation and publication of each study. Syreon's repeat business rate is over 80%; a testimony to its quality, reliability and dependability for biopharmaceutical Sponsors.
Biomarkers
Syreon principal scientists are expert in the rapidly growing field of clinical genomics and biomarkers. Dr. Keown is the academic medical director of a major referral laboratory for immunogenetics and related diseases, and has supervised the development, introduction, implementation and clinical and research application of cutting edge molecular diagnostic technologies for genetic analysis the past 20 years. He is a senior investigator of several large, multi-million dollar studies funded by senior granting agencies including Genome Canada and the National Networks of Centres of Excellence exploring gene polymorphisms, functional genomics and proteomics in organ disease and transplantation immunology. Dr. Balshaw is an expert in bioinformatics and statistics and a leader in the data structures and analysis of functional genomics and proteomics. His expertise encompasses national and international studies in many disease states, with support of drug and device development to the FDA and EMEA including the identification, development and commercialization of biomarkers for prediction, diagnosis, prognosis and therapeutic guidance in patient care. Dr. Heisel received his research doctorate in transcriptional regulation of gene activation, and integrates molecular and clinical medicine to link laboratory diagnostics and clinical therapeutics in broad areas of disease.
Research Cycle
Pre-approval Clinical Trials
These studies encompass:
> Phase I or "first time in humans" studies to assess safety, dosing and often initial exploration of pharmacokinetics and pharmacodynamics.
> Phase II or "pivotal studies" to evaluate efficacy, safety and provide additional information on dosing and pharmacokinetcs.
> Phase III, confirmation of safety and efficacy in national or global multicentre studies, often incorporating assessment of econonomic impact and quality of life.
Post-marketing Clinical Trials (Phase IV)
Population-based studies represent the most rapidly growing phase of clinical research, extending the value of marketed therapies and meeting post-approval regulatory requirements. The increased knowledge gained in phase IV research improves the integration of new therapies into routine clinical practice, addresses regulatory concerns and assesses a product's position against other available therapies. By 2004, 65% of all new molecular entities approved had a commitment for continued phase IV research. Benefits of phase IV studies include increased emphasis on continued scientific evaluation of marketed products and accumulation of pharmacoeconomic, clinical and safety data under routine practice conditions.
Disease Registries
Disease registries track the natural history, management and outcomes of patients with chronic diseases by site, region, country or continent. These sophisticated programs monitor genetic predilection, clinical risk factors, disease presentation, therapeutic strategies, current interventions, health outcomes and economic consequences to analyze current care and to guide future therapeutic research. They provide the basis for understanding of complex diseases and therapeutic interventions offer objective data for therapeutic trial design, and link investigators in community settings into prospective studies with speed and efficiency.
Special Access and Peri-approval Programs
These programs provide access to new and specialized medication often in the transitional phase pending marketing approval, or for which funding arrangements are not approved. Special access programs facilitate provision of new therapies for patients according to defined guidelines and criteria. They link physicians, patients, study sponsors and regulators to ensure the safe and effective use of these drugs and to accumulate information on outcomes and economics during the course of the study.