End-to-end patient-focused research and strategic consulting in Clinical Outcome Assessments.
We provide qualitative and quantitative research and related endpoint strategies to inform the patient voice in new and existing drug development for our pharmaceutical sponsors.
Mission Statement
At COS, we are committed to continuous, dedicated support across all facets of clinical outcomes research that inform patient care value decisions.
COA Research:
Navigating Complexity with Precision
From clinical study support to post-market monitoring — our approach helps organizations navigate the complexities of inclusion of clinical outcomes assessments in the drug development process.
Clinical Outcomes Solutions
Strategic Input
1. Basic Research
2. Non-Clinical Studies
3. Clinical Studies
Target Identification
The initial phase of basic research where scientists identify and validate biological targets that could potentially lead to the development of new therapeutic drugs.
Compound Screening
The methodical testing of a library of chemicals or compounds to identify those that have a desirable biological effect on a target identified in drug discovery.
Lead Identification
The process of selecting the most promising compounds from a screening, based on their efficacy, potency, and safety profiles, for further development in drug discovery.
In Vitro Studies
Experimental procedures conducted in a controlled environment outside a living organism, typically using cells or biological molecules, to understand biological mechanisms or test the effects of drugs.
In Vivo Studies
Experiments are conducted on living organisms, such as animals or plants, to observe biological responses and gather data on the effects and efficacy of treatments under physiological conditions.
Required Standards
The established regulatory and scientific guidelines and criteria that must be met to ensure the validity, reliability, and ethical compliance of biomedical research and testing.
Phase I Trials
Clinical trials in humans, primarily focused on evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug.
Phase II Trials
Clinical studies that assess the efficacy of a drug and further evaluate its safety in a larger group of people with the condition it is intended to treat.
Phase III Trials
Large-scale clinical studies conducted to confirm the effectiveness of a drug, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.
4. Regulatory Review
Filing & Application
The formal submission of all necessary documentation and data about a new drug to regulatory authorities, seeking approval for its commercial use.
Evaluation
The thorough review and assessment of the submitted drug application, focusing on safety, efficacy, and quality to determine its suitability for approval.
6. FDA Post-Marketing
Post-Release Monitoring
The surveillance and assessment of a drug's performance and efficacy after it has been approved and released to the market.
Over a decade of excellence,
growth, and innovative science.
Over a decade of unwavering commitment to excellence, remarkable growth, and a relentless pursuit of innovative scientific breakthroughs, positioning COS as a trusted leader in clinical outcomes research.
Trusted by top pharmaceutical and biotechnology companies, clinicians, and policymakers.
Empowering the healthcare ecosystem through unwavering trust and collaborative partnerships with industry leaders, renowned clinicians, and influential policymakers.
Expertise
Our team comprises highly qualified and experienced researchers who provide best-in-class support that drives meaningful outcomes for our clients and sponsors.
Decades of subject matter expertise across various research categories, fields, and services
Industry leaders in clinical outcomes research
Global presence provides extensive access and knowledge to diverse markets and studies
Innovation
We constantly seek to innovate and improve our services and solutions, leveraging the latest technologies, tools, and techniques to drive better sponsor outcomes.
Adapt to the latest scientific methodologies
Develop and implement innovative solutions to complex problems, such as group concept mapping and Meaningful change threshold derivation
Partnership
We work closely with our sponsors to understand their unique needs and requirements and develop customized solutions for their goals and challenges.
Foster collaborative, long-standing relationships
Align and focus our resources on the sponsors’ priorities
Meet your goals on time and on budget
Stewardship
We are invested in your success - for the long term - and help manage your budget with innovations that save time and money.
Real-time project updates reduce waste and downtime
Supported by highly skilled and certified project management
Quality
We are committed to delivering high-quality services and solutions — we adhere to the highest standards of quality and integrity in everything we do.
Dedicated Business Units (BUs) focused on a specific area of expertise
Director-lead projects ensure premium research with maximum results
Backed by world-class Technical Support Units (TSUs)
Simplicity
We are singularly focused on delivering the best possible outcomes for our sponsors and are passionate about helping our clients achieve their goals and objectives.
Multi-category expertise from one source
Service bundling across segments creates better pricing
Global footprint and infrastructure result in consistent solutions
Guided by Our Values.
At our core, we are guided by principles that shape our decision-making and define our behavior. These values serve as our compass, helping us stay true to our purpose.
Our Mission
To advance the science of patient outcomes through innovative solutions and deep partnerships with our clients. We are dedicated to transforming COA research into a powerful tool for improving patient lives and creating value for our clients. With a passionate commitment to excellence, we strive to drive measurable impact on patient outcomes and make a meaningful difference in patients' lives worldwide.
Our Vision
To create a better patient future by leading innovative clinical outcomes research. By working closely with our clients and partners, we can transform the field of COA research into a powerful tool for improving patient health and wellbeing.
Our Philosophy
Be responsive, dedicated, honest, and efficient in meeting your research
needs to support outcomes measurement strategy for drug development.
Our Values
Integrity
We uphold the highest standards of ethics and integrity in all aspects of our work, ensuring transparency, honesty, and accountability.
Trust
We cultivate a culture of mutual trust and respect among our employees, creating a supportive and collaborative work environment.
Community
We collaborate to positively impact the organization and its employees, promoting a culture of support and teamwork.
Empowerment
We provide opportunities for growth and development, encourage ownership and responsibility, and foster a culture of innovation and creativity.
Stacie Hudgens, MSc
Chief Executive Officer
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