OUR SERVICES & SPECIALTIES

Clinical Evidence Solutions LLC is a tailored Contract Research Organization (CRO) model, including: 

  • Strategic clinical evidence generation

  • Clinical development planning and protocol design 

  • Investigator and site identification, selection, and activation 

  • Study execution and trial management 

  • Data management solutions (eConsent, ePRO, EDC) 

  • Biostatistical strategy and data analysis 

  • Regulatory strategy and agency support 

  • Market focused evidence to support product launch

  • Post-market clinical surveillance 

  • Usability and Human Factors Engineering 

  • Developing scientific publications and Marketing papers

Clinical Evidence Solutions, LLC is a full service CRO offering customized, right sized partnerships. Whether you are an early stage start-up or a mature organization with commercial products, we adapt our approach to meet your specific clinical, regulatory, and business objectives. 

Contact Us

  • Strategic Clinical Evidence Generation

    Development of comprehensive evidence libraries to support regulatory submissions, investor confidence, customer adoption, and reimbursement strategies

    Regulatory guidance and hands on experience to bring products to market efficiently while avoiding common pitfalls and delays

    Creation of strategic clinical evidence roadmaps with clearly defined, decision driving milestones, including:

    - Concept feasibility and proof of concept

    - Prototype testing and engineering validation

    - Human Factors Engineering / Usability

    - Customer and consumer acceptance and adoption

    - Market positioning and comparative evidence

    - Real-World Evidence

    Development and management of realistic, defensible budgets and timelines aligned with program objectives

  • Protocol Design, Development & Study Execution

    Design and execution of fit-for-purpose clinical protocols supporting focused evidence needs in the U.S. and EU

    Compliance with applicable regulations and standards, including U.S. Food and Drug Administration, International Council for Harmonization, and European Union Medical Device Regulation

    Careful attention to sample size justification and statistical rigor to ensure high-integrity, decision-ready data

    Institutional Review Board / Ethics Committee submissions, approvals, informed consent development, and required reporting

  • Site & Investigator Management

    Strategic site and investigator identification, qualification, and selection

    Ongoing site oversight and relationship management to ensure data quality and enrollment performance

  • Study Execution & Trial Management

    End-to-end clinical trial management and sponsor coordination

    Clinical trial registration and reporting, including ClinicalTrials.gov and applicable international registries

  • Data Management & Analysis

    Data management solutions including:

    - eConsent

    - ePRO (Patient-Reported Outcomes)

    - EDC (Electronic Data Capture)

    - Validated CRFs (Case Report Forms)

    Biostatistical planning and key statistical considerations

    Final clinical study reports and support for peer reviewed publications

Get Started