Define Research Objectives & Hypothesis
With decades of clinical research experience, deep therapeutic understanding, and a commitment to patient-centered drug development, WEP is ideally positioned to help Sponsors define research questions, refine hypotheses, and develop study designs that are scientifically valid, feasible, and aligned with regulatory expectations.
WEP will support Sponsors with the following:
Early-Stage Consulting & Feasibility Assessment
- Assist Sponsors in defining clear and achievable research objectives based on regulatory requirements, scientific advancements, and market needs.
- Help assess feasibility, considering factors like patient populations, regulatory hurdles, and competitive landscape.
- Using real-world evidence (RWE) and historical trial data, we guide Sponsors in refining their study endpoints and expectations.
Patient-Centric & Operational Feasibility
- Assess patient eligibility criteria to ensure the research hypothesis is practical and achievable.
- Provide site selection and investigator input, ensuring that the trial is operationally feasible.
Protocol Development & Hypothesis Refinement
- Collaborate with Sponsor teams to develop study protocols, ensuring that objectives align with scientific rigor and regulatory expectations.
- Utilize biostatistics and epidemiology expertise to refine hypotheses and endpoints, balancing clinical relevance with statistical power.
- Help define primary and secondary endpoints, ensuring they align with regulatory pathways (e.g., FDA, EMA).
Regulatory & Compliance Considerations
- Ensure that research objectives and hypotheses meet Good Clinical Practice (GCP) and global regulatory requirements.
- Provide insights into risk-based trial designs, helping Sponsors anticipate challenges and mitigate risks.
Competitive & Scientific Landscape Analysis
- Help Sponsors shape research questions that differentiate their product from competitors, by conducting competitive intelligence and literature reviews.
- Provide real-world and historical trial data to refine research hypotheses and optimize trial designs.
Trial Design & Statistical Modeling
- Utilize advanced statistical modeling and simulations to predict trial outcomes, helping Sponsors refine objectives.
- Assist in selecting appropriate randomization strategies, control groups, and adaptive trial designs.