Transforming research in
complex human diseases
Agile adaptive trials and companion genome diagnostics will guide novel targeted biological therapies focusing on precise disease mechanisms to replace legacy treatments in complex diseases.
Mandatory economic and clinical surveillance will ensure the effectiveness, safety and cost-efficiency of new treatments and support performance-based reimbursement within tight health budgets.
Real-world evidence will define need and usage, and outreach programs with expert systems and telemedicine will support delivery of these new treatments closer to home for convenience and efficiency.
Innovative clinical trials
for precision medicine
New paradigms for participant selection and trial design, driven by predictive biomarkers, advanced computing and computational sciences promise to accelerate testing and transform the drug development process.
AND SURROGATE OUTCOMES:
Predictive markers indicating response to novel therapies enable efficient patient selection through baseline selection (BS) or short run-in (SRI) designs with maximum opportunity for benefit in agile adaptive or surrogate trials.
AND SEQUENTIAL TRIALS:
Adaptive designs permit continuous evaluation of study outcomes according to pre-specified stopping rules, and sequential addition of new cohorts or follow-on steps to incorporate novel findings and select the most promising therapies.
UMBRELLA AND BASKET TRIALS:
Umbrella studies allow us to test the effect of different drugs on a variety of genetic mutations in a specified tumor, while basket studies enable us to explore the effects of a single therapy on a variety of cancer types.
policy pricing and market access
HEALTH ECONOMICS AND POLICY
Syreon Research Institute (SRI) provides expert evidence synthesis, health economics, health policy and public health, and conducts training for health providers, pharmaceutical and health services sectors.
SRI provides cutting-edge research services to collect and interpret the evidence for public health decision-making both for all participants in the field of public health and epidemiology.
Decision analytic models are indispensable to synthesize evidence, extrapolate beyond observed data, link intermediate and final endpoints, generalize results to other settings and demonstrate uncertainty.
We develop rigorous, verified and validated models utilizing the most recent modelling guidelines and design these to be user-friendly and easily incorporated in HTA submissions and suitable for publication.
STRATEGIC PRICING AND MARKETING ACCESS
Shorter product development cycles and intense competition are constant threats to new pharmaceutical products or medical devices that often struggle to achieve their profit and volume objectives.
Comprehensive understanding of market and patient needs, pricing options and therapeutic benefits, and in particular approval and payment options are critical to overcome these barriers.
We work closely with companies to ensure their products are optimally priced for rapid market uptake and are tightly aligned with patient, provider and payer needs.
safety, effectiveness and productivity
SAFETY, EFFECTIVENESS AND DISEASE ACTIVITY
Our leading scientists have been at the forefront of health outcomes research for more than 25 years helping to shape and develop this field into a rigorous scientific discipline for health care improvement.
Our phase large 4 studies, disease registries and real-world data allow us to track the safety and effectiveness of new treatments or combinations for performance-based pricing programs and regulatory reporting.
Our digital networks use our expert ePRO systems with a broad array of validated instruments to record changes in patient health and disease activity in real time for cost-utility analysis and targeted intervention.
Combining our ePRO patient health data with simultaneous resource utilization and other indirect and societal costs enables us to calculate disease burden by patient, treatment cohort or study population.
HEALTH QUALITY, PREFERENCES AND PRODUCTIVITY
We excel in the measurement of health quality, using proven instruments with patient or provider input from smart phones, tablets or other sources to track well-being and health response in real time.
Treatment preferences are becoming increasingly important in the world of patient-centred care, and our measures enable us to provide finger-tip access to barriers to care and preferences for health care delivery.
Our goal is to enable patients return to health quickly and to maintain a productive role in society. Our tools track these parameters and provide invaluable information in crafting effective treatment strategies.
and personalized healthcare
REAL-WORLD DATA (RWD) AND EVIDENCE (RWE)
The 21st Century Cures Act, passed in 2016, places additional focus on the use of these types of data to support regulatory decision making, including approval of new indications for approved drugs (US FDA).
Real-world data (RWD) are the data relating to patient health and the delivery of healthcare collected from a variety of sources including EHR, claims and billing activities, registries, patient data and mobile devices.
Real-world evidence (RWE) is the clinical evidence regarding the use and potential benefits or risks of a medical product derived from analysis of RWD via observational studies, pragmatic trials or other methods.
Syreon combines many streams of RWD including patient health data and resource utilization to monitor postmarket safety and adverse events, and to develop decision support tools for clinical practice.
PERSONALIZED HEALTHCARE STRATEGIES
Informed, connected and affluent populations demand access to, and delivery of, new treatments closer to home for convenience and efficiency via outreach programs with expert systems and telemedicine support.
Major providers such as Kaiser Permanente now conduct more consultations virtually than in person (52% of 111 million), with improved patient satisfaction. This will become the norm within a decade!
But developing precise and efficient care strategies for personalized health is challenging and a critical component of the treatment process. This is where Syreon excels!