Unparallel Support :
Our Competitive Advantage

Unlock the power of synergy and innovation through a unique business model that integrates dedicated business units and specialized technical support units — positioning COS at the forefront of clinical outcomes research with an unmatched strategic advantage.

Dedicated Cross-Functional
Business Unit Structure

Experience the advantage of COS’ cross-functional Business Unit structure. With focused expertise in each department, we provide unmatched research and consulting services for clinical outcome assessments across the drug development continuum.

Dedicated Business Units

Clinical Outcome Assessments (COAs)

  • In the realm of clinical outcomes research, our Clinical Outcome Assessments business unit is your partner in developing, validating, and implementing COAs that truly matter.

    With a deep understanding of patient-reported outcomes, we guide you through the intricate process of capturing meaningful data that reflects the patient experience.

    Our expertise ensures that your trials and interventions have reliable and sensitive measures, fostering confident decision-making and regulatory success.

  • At COS, our Quantitative Science business unit stands at the forefront of data analysis and interpretation.

    Our team of statistical experts harnesses the power of data to uncover meaningful insights, transforming complex information into actionable recommendations.

    With a commitment to precision and innovation, we ensure that your clinical outcomes research benefits from rigorous quantitative analysis, enabling informed decisions and robust outcomes.

  • COS's Prospective Studies business unit is dedicated to uncovering new perspectives in clinical outcomes research.

    We design and execute prospective studies that provide real-time insights into the effectiveness and safety of interventions.

    With a focus on robust methodologies, our team navigates the complexities of prospective research, delivering data that empowers evidence-based decision-making and helps shape the future of healthcare.

Accelerated Innovation Through Specialization

Our dedicated business units are innovation engines designed to foster deep specialization and rapid development in their respective fields. Benefit from industry-leading clinical research methods with acclaimed field research experts to make sense of complex systems and surface solutions that keep you ahead in the dynamic landscape of healthcare research.

Clinical Outcomes Solutions

Organizational Structure

The above diagram illustrates the organizational structure of Clinical Outcomes Solutions, highlighting its three central business units: Clinical Outcome Assessments, Quantitative Science, and Prospective Studies, each depicted as part of a Borromean ring. These units are driven by Director-Led Research teams and Technical Support Units (TSUs), enhancing research efficiency and compliance. Intersections between the rings signify collaborative zones, while the central overlap symbolizes a hub of innovation. At the core, the sponsor benefits from the synergy and innovation stemming from these dedicated, cross-functional business units, promoting specialized and rapid development in clinical outcomes research.

Key benefits of
cross- functional business units.

  • Each business unit provides custom-tailored services and solutions to meet the unique needs of each sponsor, ensuring the highest—quality outcomes.

  • Our researchers provide extensive experience and industry knowledge — offering innovative solutions and strategies that help navigate complex challenges and drive successful outcomes.

  • With our data-driven approach, we are committed to delivering the highest quality results that enable our sponsors to have the information they need in today’s complex healthcare landscape.

  • We are committed to providing sponsors with the most reliable and comprehensive evidence and reports — ensuring that our sponsors have what they need to make informed decisions. 

  • Our director-led approach offers a distinct advantage by leveraging the expertise and leadership of our experienced directors. We ensure that our research initiatives are guided by a deep understanding of the industry, cutting-edge methodologies, and strategic insights. 

  • Each business unit is backed by TSUs, departments that supply a broad range of skills and expertise to support the unit’s related needs and streamline operations. 

  • Our services, solutions, and strategic partnerships offer clients and sponsors complete coverage across the COA research landscape — eliminating the need to engage with outside vendors and saving you time and money.

Backed by World-Class
Technical Support Units.

Our Technical Support Units play a pivotal role in augmenting and reinforcing the capabilities of each of our Business Units — empowering each business unit to oversee studies comprehensively from inception to completion.

Technical Support Units

  • Project Planning
    Providing expertise regarding the best approach for recruiting the study population efficiently and cost-effectively, keeping within study design and project timelines.

    Protocol Development
    Providing strategic input to study protocol sections relevant to recruitment feasibility and approach and assist with various platform selections.

    Recruitment Resource Management
    Identifying and selecting qualified study sites and third-party vendors, ensuring they meet study requirements and standards, and facilitating ongoing communications.

    Participant Recruitment & Retention
    Developing and implementing strategies for recruiting and retaining study participants, including creating detailed site training materials, continued communications, and fostering ongoing relationships.

    HIPPA/GDPR Compliance, Data Collection & Management
    Developing, implementing, and managing data collection methods and procedures, ensuring data is accurate, complete, and secure throughout all study phases.

    Quality Management
    Establishing and maintaining quality standards for the study, including quality control and quality assurance measures.

    Project Monitoring & Control
    Tracking progress, managing timelines, and making necessary adjustments to keep study enrollment on track and ensure data is delivered on time and within the pass-through budget.

    Regulatory Support & GCP/ICH Compliance
    Ensuring the study adheres to all applicable regulatory and human subject research requirements, including FDA and other international regulatory agency guidelines and protocols.

    Reporting & Documentation
    Providing regular recruitment and target goal updates, documenting spontaneous AE reports, and processing study-related data per client requirements.

    Study Closeout
    Ensuring all study procedures are complete, data is collected and verified, and the study is closed according to local and central institutional review board requirements.

  • Project Planning
    Defining study objectives, determining study scope, and creating a detailed study plan that outlines tasks, timelines, milestones, and resource requirements.

    Resource Allocation
    Identifying and allocating the necessary resources to ensure successful project completion.

    Risk Management
    Identifying potential risks and developing mitigation strategies, including contingency plans for unexpected events.

    Budget Management
    Establishing a project budget, monitoring expenses, and controlling costs to ensure that the project stays within budget constraints.

    Communication & Collaboration
    Facilitating communication and collaboration between project team members, stakeholders, and sponsors to ensure everyone is on the same page and that the project is progressing smoothly.

    Quality Management
    Establishing and maintaining quality standards for the project, including quality control and assurance measures.

    Project Monitoring & Control
    Tracking progress, managing timelines, and making necessary adjustments to keep the study on track and ensure it is delivered on time and within budget.

    Change Management
    Managing changes to project scope, timelines, and requirements, including assessing the impact of changes on the project and making necessary adjustments to keep the project on track.

    Stakeholder Management
    Providing regular status updates and reports on study progress and outcomes, including maintaining accurate study documentation to ensure that information is up-to-date and accessible.

    Reporting & Documentation
    Ensuring all study procedures are complete, data is collected and verified, and the study is closed according to requirements.

  • Statistical Analysis
    Conducting advanced statistical analyses on study data, including descriptive statistics, inferential statistics, longitudinal data analysis, and survival analysis.

    Clinical Data Reporting
    Generating clinical data reports, such as data listings, summary tables, and figures, for clinical trial reporting.

    Statistical Programming
    Developing and validating SAS programs to support clinical study data analysis and reporting, ensuring that the programs are efficient and error-free.

    Data Integration
    Integrating data from various sources into SAS datasets, including lab data and electronic survey records.

    Quality Control
    Performing quality control checks to ensure that study results are accurate and identifying any anomalies or discrepancies.

    Regulatory Compliance
    Ensuring the SAS programming process complies with all applicable regulatory requirements, including FDA and other regulatory agency guidelines and protocols.

    CDISC Standards
    Applying CDISC (Clinical Data Interchange Standards Consortium) standards to SAS programs ensures that data is standardized and can be easily shared and analyzed.

    High-Quality Data Visualization
    Creating visualizations and graphics to help communicate study findings and trends and make data easier to understand and interpret.

    Project Management
    Coordinating with project management to ensure that the SAS programming process is aligned with the project plan and timelines and making necessary adjustments to keep the process on track.

  • Medical Writing
    Developing high-quality scientific and medical content for various publications, including manuscripts, abstracts, posters, regulatory documents, scientific reports, and other materials.

    Publication Planning
    Developing a comprehensive publication plan that outlines the strategy for disseminating study results to various audiences, including scientific journals, conference presentations, and other channels.

    Publication Review
    Conducting rigorous peer review of study publications to ensure they meet the highest scientific and editorial standards.

    Scientific Messaging
    Developing clear, concise, and scientifically accurate messaging for study results that are easy to understand by various audiences, including healthcare professionals, patients, and the general public.

    Regulatory Compliance
    Ensuring that all scientific and medical content complies with applicable regulatory guidelines and requirements, including FDA and other regulatory agency protocols.

    Information Requests
    Responding to general and medical information requests from healthcare professionals and other stakeholders ensures that accurate and up-to-date information is provided.

    Conference Support
    Supporting conference presentations, including developing slide decks, abstracts, posters, and other materials.

    Scientific Training
    Developing and delivering scientific training programs for internal staff, clients, and other stakeholders, helping to build scientific knowledge and expertise.

  • Database Design & Development
    Designing and developing a database that meets the study requirements, including selecting the appropriate data structure and ensuring data integrity.

    Data Collection
    Developing and implementing methods and procedures for collecting data, including data entry, capture, and verification.

    Data Cleaning
    Cleaning and verifying the data to ensure that it is accurate, complete, and consistent, and identifying and resolving any data inconsistencies.

    Regulatory Compliance
    Ensuring the data management process complies with all applicable regulatory requirements, including FDA and other regulatory agency guidelines and protocols.

    Quality Management
    Establishing and maintaining quality standards for the data, including quality control and quality assurance measures.

    Security & Privacy
    Ensuring that data is secure and that appropriate privacy measures are in place to protect the confidentiality and privacy of study participants.

    Data Sharing & Reporting
    Providing access to the data to authorized personnel and creating reports and visualizations to communicate study findings to stakeholders and regulatory agencies.

    Data Archiving
    Ensuring that data is archived and stored in a secure and accessible manner for future use and reference.

    Project Management
    Coordinating with project management to ensure that the data management process is aligned with the project plan and timelines and making necessary adjustments to keep the data management process on track.

  • Quality Assurance
    Establish consistent and high-quality standards, guidelines, and procedures throughout all processes and deliverables to ensure compliance and customer confidence.

    Regulatory Compliance
    Adhering and conforming to applicable laws, regulations, and specifications set by governing bodies to ensure ethical and legal practices within the organization.

    Data Privacy Compliance
    Implementing measures and safeguards to ensure confidentiality, integrity, and personal and sensitive data availability per applicable laws and regulations.

    Quality Compliance
    Adhering to established quality standards, guidelines, and regulations to ensure services and processes meet specified requirements and expectations.

    Ethical Compliance
    Embedding ethical principles, values, and standards in every aspect of our business conduct, ensuring integrity, fairness, and respect for all stakeholders.

    Advertising & Marketing Compliance (GDPR)
    Ensuring that advertising and marketing practices align with relevant laws, regulations, and industry guidelines to promote transparency, accuracy, and fair competition.

    Education & Training
    Providing comprehensive and targeted programs to educate and train individuals on regulatory requirements, ethical standards, and best practices.

Research Teams
Focused on Research.

Our director-led research teams are focused on our clients' research, while Technical Support Units expertly handle all aspects of project management, compliance, data management, statistical programming, medical communications, and compliance.

Clinical Outcomes Solutions

Clinical Research Process

The above diagram illustrates the clinical research process at Clinical Outcomes Solutions, which showcases the support provided by various Technical Support Units (TSUs) to COS researchers. Central to the model is the researcher, who is connected to both the sponsor and TSUs. Each TSU — depicted in green — facilitates efficient and compliant research operations, allowing researchers to focus on critical scientific inquiries with a robust support system.

Key benefits of
Technical Support Units. 

  • TSUs allow for streamlined and efficient study management — reducing the time and cost required to complete each study and increasing overall productivity.

  • TSUs ensure premium quality research and reports with rigorous quality assurance, meticulous attention to detail, and advanced data analysis — delivering exceptional outcomes and evidence-based recommendations.

  • TSUs offer specialized expertise, leveraging a team of experienced professionals with in-depth knowledge and skills in their respective fields — ensuring comprehensive and accurate support for diverse research needs.

  • TSUs mitigate the risks associated with study coordination, project management, data management, and SAS programming — minimizing the potential for errors or delays that could impact study outcomes.

  • TSUs ensure consistency and standardization, maintaining high-quality standards and protocols across studies for reliable, comparable outcomes supporting accurate analysis and decision-making.

  • TSUs provide flexible and adaptable solutions, enabling us to respond to changes swiftly, integrate new methodologies, and customize services to optimize research outcomes for each study’s unique needs.

  • TSUs enhance communication by providing concise documentation, facilitating collaboration, ensuring regulatory compliance, and offering project management support.