Our Services
Strategic Planning for Clinical & Regulatory Pathways
We develop tailored clinical and regulatory strategies that align with your product’s intended use, risk classification, and market goals. This includes determining the appropriate FDA pathway (510(k), PMA, De Novo), defining clinical study requirements, and mapping a clear timeline and milestones for both clinical and regulatory activities. Our goal is to help you avoid delays, minimize risks, and streamline the journey from concept to market clearance.
U.S. Site Identification & Qualification
Selecting the right clinical sites is critical to your study’s success. At SPMD Pathway, we connect you with trusted U.S. sites from our verified network, carefully matched to your product and protocol requirements for optimal study performance. We evaluate potential sites based on experience, infrastructure, patient population, and their track record with similar device trials. Through detailed site feasibility assessments and investigator vetting, we ensure that each selected site meets regulatory standards and aligns with your study’s clinical and operational needs.
Patient Recruitment & Enrollment Strategy
Enrollment is one of the most challenging aspects of any clinical study. We design recruitment strategies tailored to your target population and therapeutic area, optimizing site performance and minimizing delays. This includes working closely with sites on outreach plans, pre-screening tools, patient materials, and tracking recruitment KPIs to keep your study on schedule.
Clinical Staff Training
Your product is unique — and so is the training we provide. We develop and deliver customized training programs for site staff on your investigational product, ensuring consistent, high-quality study conduct. Our programs cover protocol-specific procedures, device handling, regulatory compliance, documentation standards, and Good Clinical Practice (GCP). By offering tailored, hands-on training, we minimize protocol deviations and ensure that each site operates at the highest standard from day one.
Study Startup & Kickoff Management
We manage all operational aspects of study initiation, including site contract coordination, IRB submission and support, regulatory document collection, and site readiness assessments. We lead comprehensive study kickoff meetings to align all stakeholders — sponsors, sites, vendors — ensuring clarity on timelines, deliverables, and operational expectations.
Oversight of Clinical Operations
As your boots-on-the-ground partner, we oversee the day-to-day operations of your clinical study, acting as the liaison between your team and U.S. sites. We work with your team and vendors to identify challenges early, address operational issues, and maintain seamless study progress.
Problem Solving During the Study
Unexpected issues are inevitable in clinical research — delays, deviations, or operational bottlenecks. We pride ourselves on our proactive, solution-driven approach. We troubleshoot problems as they arise, implement corrective actions, and keep your study moving forward while maintaining regulatory and protocol compliance.
Site Closeout & Post-Study Coordination
We manage the clinical closeout process from final data collection and query resolution to regulatory reporting and site documentation archiving. We ensure that sites complete all required procedures, and that final reports are prepared in accordance with FDA and IRB requirements. Post-study, we support activities like follow-up data collection, publication coordination, and preparation for regulatory submissions.
Regulatory & Clinical Strategy Alignment
Clinical and regulatory efforts must work hand-in-hand. We continuously align your clinical development activities with regulatory expectations, ensuring that the data you generate will support your intended FDA submission and commercialization plans. This includes early engagement with regulatory experts, risk assessments, and evidence generation planning to strengthen your market positioning.
Additional Tailored Support
Need something else? We’re here to collaborate, discuss, and map out any additional requirements you have. Let’s build the exact support you need together.