In an attempt to meet regulatory expectations, clinical trials are challenged by highly complex protocol design. But these study plans can fail to reflect the standard of care, site capabilities, or the realities of patient eligibility. The result is often slower site activation, greater burden on patients and staff, limited access and enrollment, increased likelihood of costly amendments, and in some cases, study failure.
The opportunity to address these challenges has never been greater. Regulators have begun encouraging more pragmatic approaches, acknowledging the strain complex trials place on patients and sites. To seize this moment, sponsors need a process that combines deep clinical expertise with genuine insight into care delivery, site operations, and patient populations so protocols are built not just for approval, but for operational feasibility, recruitment efficiency, and inclusivity from day one.
Design data-informed trials aligned to sites and patients
Paradigm Health Trial Design & Protocol Optimization helps sponsors develop protocols that are scientifically rigorous, operationally feasible, and aligned with real-world care delivery.
Whether designing from the ground up or optimizing a protocol already in motion, we bring together clinical, regulatory, operational, and data science expertise to ensure protocols reflect the realities of site capabilities, community care, and diverse patient populations.
Through structured, collaborative engagements, we analyze key protocol elements, including study design, eligibility criteria, comparator arms, biomarker testing strategies, and study workflows, to deliver actionable, data-driven guidance. The result: protocols attractive to Paradigm Health sites that reduce burden, improve feasibility, increase recruitment potential, and support regulatory outcomes.
Trial design
Paradigm Health partners with Sponsors early in the trial lifecycle to design scientifically rigorous protocols that are feasible to execute across real-world care settings.
Paradigm Health helps shape critical elements, such as study structure, I/E criteria, biomarker testing strategies, and schedule of events/activities, using patient data, site capabilities, and feedback from our network to ensure recruitment and operational goals are achievable.
Protocol optimization
For active or near-activation trials, Paradigm Health delivers targeted assessments to identify and address protocol barriers. We evaluate the impact of eligibility criteria on patient funnel volume, assess treatment and schedule of event alignment with standard of care, and review site-level feasibility. Findings and recommendations are captured in a Protocol Optimization Report to support enrollment improvements and inform potential amendments.
Protocol development and refinement at any stage, powered by clinical data and operational insights
Whether you’re building a protocol from the ground up or refining one already in motion, Paradigm Health delivers the same expert-driven, data-informed services to improve clinical, operational, and regulatory outcomes. Our approach is adaptable to meet sponsors where they are.
Paradigm Health delivers a cohesive set of consultative services and actionable assessments:
Study design and methodology
Paradigm Health collaborates with medical, data science, and clinical operations experts to develop or refine protocol elements that are scientifically sound, operationally feasible, and aligned with clinical, regulatory goals.
- Define trial arms, randomization strategy, and endpoint selection
- Balance scientific intent with executional feasibility and approval pathways
- Ensure methodology supports meaningful, measurable outcomes
Inclusion/exclusion criteria optimization
Using patient data and input from community and academic care settings, Paradigm Health designs eligibility criteria that enable efficient recruitment, increase diversity, and reflect care realities across different sites.
- Draft or revise I/E criteria to maximize eligible patient pool
- Optimize language for human and AI/ML interpretability
- Align criteria with protocol objectives and care delivery
- Improve demographic representation across academic and community sites
Comparator arm and biomarker strategy
Paradigm Health evaluates comparator and biomarker strategies for clinical relevance, standard-of-care alignment, and site feasibility to ensure these elements are practical to implement and tied to study outcomes.
- Select comparators that reflect current practice and site capabilities
- Design biomarker testing strategies to optimize patient identification at the time of eligibility
- Avoid operational complexity that delays or limits site activation
Clinical operations alignment
Paradigm Health assesses protocol workflows, schedule of activities (SOA), and visit requirements against standard-of-care patterns and site capabilities to reduce burden, streamline execution, and manage cost:
- Evaluate protocol demands against actual site workflows and capabilities
- Recommend SOA and procedure changes to align to standard of care while maintaining scientific integrity
- Identify opportunities to reduce visit burden and simplify trial conduct
Regulatory and site-level insight
With cross-functional expertise and data from its provider network, Paradigm Health incorporates regulatory guidance and insights to improve protocol viability, site fit for Paradigm Health partners, and approval potential:
- Conduct regulatory feasibility assessments to identify risk areas
- Analyze SOC, testing patterns, and patient demographics across settings
- Ensure protocol elements reflect what sites can realistically deliver
