Clinical Consulting
Jump to: Strategy & Evidence Development | Clinical Ops & Study Management
Strategy & Evidence Development
We partner with sponsors to design clinical programs that align regulatory expectations, scientific rigor, and business objectives. Our focus is ensuring that studies are structured correctly from the start to minimize risk and support successful submissions.
Trial Design
We design studies that align regulatory requirements, clinical evidence needs, and business objectives. Working closely with biostatistics and key stakeholders, we structure endpoints, methodologies, and data strategies to ensure studies are scientifically sound, operationally feasible, and positioned for regulatory success.
Protocol Development & Writing
We develop comprehensive, submission-ready protocols grounded in scientific clarity and operational detail. From literature review and background development to safety definitions, reporting requirements, and schedules of assessments, we ensure each protocol supports both regulatory expectations and efficient study execution.
Database Selection & Design Optimization
We guide the selection and configuration of EDC platforms to ensure the study’s data infrastructure supports its endpoints and compliance requirements. By aligning database design with study objectives — including PROs, Core Lab reads, device accountability, and site management — we help ensure clean data collection and analysis readiness from day one.
Additional strategy services
Evidence strategy development
Case Report Form (CRF) creation aligned to endpoints
Table shell development (listings and figures)
Clinical compliance assessments
Clinical Study Report (CSR) development and writing
SOP creation (IDE, IND, MDR alignment)
Vendor/supplier qualification frameworks
Regulatory-aligned data planning
Clinical Operations & Study Management
Operational support for all phases of your clinical study. We provide structured oversight, vendor coordination, and site engagement to ensure compliant and efficient execution.
Study Startup & Planning
We establish the operational foundation necessary for successful study execution. This includes development of Study Management Plans, Monitoring Plans, Data Management Plans, recruitment strategies, and Trial Master File structures. We align timelines, budgets, and risk mitigation strategies to ensure studies launch efficiently and remain on track throughout their lifecycle.
Site Qualification & Training
We support site selection and readiness to ensure investigators and coordinators are fully prepared to execute the protocol. From defining qualification criteria and vetting principal investigators to delivering protocol, EDC, Core Lab, and device training, we help establish consistency, compliance, and operational clarity across study sites.
Vendor Oversight & Study Management
We provide ongoing oversight of vendors, sites, and supporting teams to ensure coordinated and compliant study execution. This includes recruitment tracking, risk identification and mitigation, budget management, and development of clear status communications. Our goal is to maintain visibility, accountability, and steady progress throughout the study.
Additional operations services
Vendor oversight and coordination
Recruitment and enrollment support
Timeline and status reporting
Communication materials (slides, updates, reports)
IRB submission preparation
Informed Consent Form (ICF) development
Site monitoring coordination
Ongoing study management and performance tracking
Design your study with confidence
We’ll help position your program for regulatory approval and operational success.
