Quality Assurance

Quality Oversight, Consistency and Integrity

At Exact Clinical Research, we know that true clinical excellence begins - and endures - with uncompromising quality. As a FLEX CRO, we deliver proactive, senior-led quality oversight that strengthens the integrity aspect of your research from first-in-human to late phase, pivotal clinical studies. Our approach is grounded in accuracy, transparency, and inspection readiness—ensuring that every element of your clinical program aligns with FDA, EMA, ICH-GCP, and global regulatory expectations. Whether you are preparing for early-stage operational build-out or scaling towards phase 2-3 execution, Exact’s quality framework is designed to protect participants, reduce operational variability, and ensure your data can withstand regulatory scrutiny.

A Trusted FLEX Partner for Quality Excellence

Biotech innovators and emerging sponsors partner with Exact to elevate their quality systems and instill confidence in every phase of clinical research. Our experienced team provides hands-on GCP support - from site qualification to final trial master file review to vendor oversight, monitoring quality, and full auditing programs. We identify risks early, implement corrective and preventative action plans, and guide teams through continuous improvement to keep your studies compliant, efficient, and inspection-ready.

With decades of experience in development, rare and complex disease studies, drug-device combinations, and late-stage global trials, Exact brings the judgment and operational precision needed to navigate the evolving regulatory landscape. As your FLEX partner, we ensure that quality is not just a function - it’s a strategic advantage that supports your milestones and accelerates your path to approval.

Quality Assurance Services

Exact Clinical Research delivers flexible, senior-led quality assurance solutions tailored to small biotech and emerging pharmaceutical companies. We operate as an extension of your internal team—strengthening your quality systems, supporting your GCP obligations, and ensuring that both your vendors and clinical sites meet the highest standards of compliance.

While our work often involves direct interaction with clinical sites and partners, we perform these activities on behalf of the sponsor, reinforcing your oversight responsibilities and protecting the integrity of your research program across all phases of development.

Why Choose Exact Clinical?

Our nimble contracting and trial startup processes allow us to set up your trial and activate sites in weeks, not months.
Pay only for the expertise you need—whether targeted monitoring or regulatory support, or an end‑to‑end program management.
Early‑stage innovators and mid‑sized sponsors trust us as their clinical services partner because we protect both runway and rigor.

In a sea of rigid, big‑box providers, Exact Clinical Research pioneered the flexible CRO model—delivering the depth of a full‑service organization with the agility your program deserves. We also have the ability to place single specialists for short-term engagements that larger CROs are unwilling to handle. Acting as an extension of your team, we scale support up or down in real time to keep budgets lean, timelines tight, and data exact.

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