ASSISTING SMALL

Biotech Start-Ups

navigate the steps in clinical research

Syreon works with small innovative biotech corporations to identify leading KOLs, and design and conduct agile, adaptive trials with key biomarkers and pharmacometrics.

SUPPORTING

Mid-Stage Companies

to speed phase 2 / 3 development

Syreon draws on its global expertise and clinical partnerships to design and execute innovative adaptive trials for regulatory submission with a compelling value dossier.

SPEARHEADING

Late Phase Research

with global biotech and Fortune 500 pharma corporations

Studies linking hundreds of sites and enrolling thousands of patients in over 40 countries with long-term follow up to define treatment options, outcomes, health quality and costs.


     

Our expertise in

key therapeutic areas

Syreon excels not only in common therapeutic areas, but also in the advancing technologies of molecular sciences, stem cell transplantation and therapeutics, immune disease and immuno-oncology, and in the broader areas of organ failure, inflammatory disease and targeted therapy.

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ONCOLOGY

Solid or hematological malignancies, signal inhibitors, biological and cellular therapeutics, or autologous and allogeneic transplantation.

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IMMUNOLOGY

Autoimmune and inflammatory disorders, immune deficiency, immunopharmacology and therapeutics, graft rejection and graft-vs-host disease.

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OPHTHALMOLOGY

Retinal disease and macular degeneration, diabetic retinopathy, retinal vein thrombosis, cataracts and anterior eye disease.

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NEUROLOGY

Degenerative brain disease and dementia, migraine, stroke, movement disorders, epilepsy, multiple sclerosis and neuroimmunology.

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DERMATOLOGY

Psoriasis and rosacea, urticarial, dermatitis and eczema, DRESS syndrome, skin malignancy, cosmetic medicine.

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RHEUMATOLOGY

Rheumatoid and inflammatory arthritis, degenerative disease and osteoarthritis, muscle and skeletal disorders, osteoporosis.

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METABOLISM

Diabetes, hyperlipidemia, obesity and metabolic syndrome, inherited disorders, diet and nutrition.

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CARDIOLOGY

Atherosclerosis, heart failure, cardiomyopathy, hypertension, arrhythmia, peripheral vascular disease and thrombosis.

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RESPIROLOGY

Asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary hypertension, influenza and pneumonia.

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INFECTION

Viral, fungal and microbial diseases, hepatitis, pneumonia, urinary tract disorders, complex and chronic infections, septicemia.

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GASTROENTEROLOGY

Inflammatory bowel disease, irritable bowel syndrome, liver disease and steatosis, stomach and colon cancer.

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NEPHROLOGY

Glomerulonephritis, diabetic nephropathy, cystic disease, renal anemia, renal metabolic disorders, dialysis and transplantation.

All the services you need from

study design to high-level publication

For study design:

TRIAL DESIGN

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.

MEDICAL DIRECTION

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.

PROJECT MANAGEMENT

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.

For study operation:

SITE MANAGEMENT

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.

DATA MANAGEMENT

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.

STUDY MONITORING

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.

For study analysis and reporting:

STATISTICAL ANALYSIS

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.

HEALTH ECONOMICS

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.

MEDICAL WRITING

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.