The type of clinical study you conduct shapes everything from design, timeline, site requirements, and data strategy. Whether you are working toward regulatory approval or generating post-market evidence to support reimbursement, understanding the clinical research landscape and study types is key for sponsors making developmental decisions.

This guide walks through the five core study types Proxima supports, with context on what distinguishes each and where execution complexity tends to emerge.

1. Feasibility Studies

Feasibility studies are early-stage investigations designed to answer one central question before committing to a larger trial: Can this work, and is it safe?

In the context of medical devices and diagnostics, feasibility studies help sponsors evaluate whether a device performs as intended in a clinical setting, identify preliminary safety signals, refine the protocol, and inform the design of a pivotal trial. They are often first-in-human or early use studies with small patient populations and flexible exploratory endpoints.

The precision required in site selection can make feasibility studies complex. Sites must have the clinical expertise, patient population access, and investigator willingness to engage with an early-stage, often unproven technology. Misjudging site readiness at this stage can distort your early data and delay the pivot to a more formal trial.

Proxima's site-centric model has been built on long-standing relationships with 125+ specialized clinical research sites. We give feasibility sponsors an advantage in identifying sites that are equipped to handle investigational-stage work. Learn more >>

2. Pivotal Trials

Pivotal trials are central to most regulatory submissions. These are controlled, endpoint-driven studies designed to generate the primary safety and efficacy evidence regulators require to approve or clear a product for market.

For medical device sponsors, pivotal trials often support a PMA (Pre-Market Approval) or De Novo submission with FDA. For drug and biologic sponsors, they are typically Phase 3 studies. The design of a pivotal trial — endpoints, comparators, sample size, study duration — is negotiated carefully with regulators, often following a Pre-Submission (Q-Sub) or pre-IND meeting.

Execution risk in pivotal trials is high. Enrollment delays, protocol deviations, and poor site performance can have direct regulatory consequences. This is where site startup speed and quality are non-negotiable.  

Proxima's clinical trial startup process includes rigorous site assessments, thorough feasibility evaluations, and strategic site selection — helping sponsors reach enrollment faster without sacrificing site quality. Learn more >>

3. Post-Market Surveillance & Ongoing Post-Market Clinical Studies

Your clinical journey extends post-regulatory approval. For medical device manufacturers operating under EU MDR and IVDR, post-market clinical follow-up (PMCF) is a mandatory and ongoing obligation. In the U.S., FDA increasingly expects post-approval studies (PAS) as conditions of approval for high-risk devices.

Post-market surveillance (PMS) and ongoing post-market clinical studies serve several functions:

• Confirming long-term safety and performance in real-world populations
• Identifying rare adverse events not captured in pre-market studies
• Supporting label expansions and changes in indications for use
• Generating evidence for payer and HTA bodies

These studies require sustained site relationships, longitudinal data infrastructure, and a regulatory team that understands how post-market evidence requirements continue to evolve.  

Proxima's regulatory affairs expertise supports sponsors in designing PMCF plans and post-approval study protocols that satisfy both U.S. and EU expectations. Learn more >>

4. IVD Clinical Studies

In vitro diagnostic (IVD) clinical studies have their own regulatory pathway, study design requirements, and site capabilities. Whether a sponsor is pursuing 510(k) clearance, De Novo classification, PMA approval, or CE marking under IVDR, the clinical evidence requirements for diagnostics differ meaningfully from therapeutic device or drug studies.

IVD clinical studies may involve:

• Analytical studies assessing precision, accuracy, and interference ‍
• Clinical performance studies evaluating sensitivity, specificity, and predictive values against a reference standard ‍
• Clinical utility studies demonstrating that the diagnostic information improves clinical decision-making or patient outcomes

The right sites for IVD studies are often clinical laboratories, academic medical centers with specific testing infrastructure, or pathology departments — not the same sites used for therapeutic device trials.  

Proxima's network includes sites with specialized IVD capabilities, and our team understands the specimen handling, workflow, and reference standard considerations unique to diagnostic development. Learn more >>

5. Real-World Evidence (RWE)

Real-world evidence studies use data generated outside of controlled clinical trial settings (including electronic health records, claims data, registries, and pragmatic trials) to answer questions about product safety, effectiveness, and value in routine clinical practice.

RWE has become increasingly central to regulatory, reimbursement, and market access strategy. FDA's Real-World Evidence Program has expanded guidance on acceptable RWE methodologies, and payers in both the U.S. and EU are actively incorporating RWE into coverage decisions.

For sponsors, RWE studies require site engagement focused on data infrastructure, EHR interoperability, and registry participation rather than protocol-specific procedures. They also require rigorous study design to ensure the evidence meets regulatory and payer standards for quality and relevance.

Proxima supports RWE study design and execution with attention to the methodological rigor that distinguishes evidence that moves the needle from data that doesn't. Learn more >>

Site Startup Across All Study Phases

Regardless of study type, one of the most consistent sources of delay in clinical development is site startup. Regulatory document collection, IRB/EC submissions, contract negotiations, and staff training all happen before the first patient is enrolled — and they all take longer than sponsors anticipate.

Proxima's clinical trial startup process is built to reduce that friction. Our approach includes:

• Rigorous site assessments to evaluate investigator experience, patient population access, and operational infrastructure ‍
• Thorough feasibility evaluations aligned to your protocol requirements and enrollment targets ‍
• Strategic site selection from our network of 125+ specialized clinical research sites

We specialize in complex trials that other CROs aren't built for — early-stage devices, combination products, AI/ML-enabled diagnostics, and studies in underserved therapeutic areas. That specialization is why sponsors who come to us after struggling elsewhere tend to stay.

Choosing the Right Partner for Your Study Type

The types of clinical studies a CRO supports, and how well they support them, varies significantly. Feasibility studies demand early-stage site relationships and regulatory flexibility. Pivotal trials demand execution discipline and enrollment velocity. Post-market studies demand sustained infrastructure and regulatory awareness. IVD studies demand diagnostic-specific expertise. RWE demands methodological rigor and data credibility.

Proxima is built to support sponsors across all of these, with the site relationships, regulatory depth, and operational experience to match.

Ready to discuss your study? Connect with our team →