Clinical Strategy & Operations

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Navigating Complexity with a Flex CRO™ Mindset

At Exact Clinical Research, clinical operations are the heartbeat of our flexible CRO model. By combining decades of sponsor‑side and CRO‑side experience, we lead with foresight—anticipating obstacles, crafting pragmatic solutions, and guiding every stakeholder toward first‑patient‑in and last‑patient‑out with confidence. Whether you need à‑la‑carte FSP clinical services or fully integrated program oversight, our approach stays the same: strategic, experienced, Exact.

A Trusted Biotech and Biopharma CRO Partner 

Emerging biotech innovators, mid‑sized pharma teams, academic investigators, and global‑health nonprofits alike rely on us because we balance rigor with resource stewardship. As an affordable CRO for biotech and biopharma, we scale support to your budget without compromising quality, tapping senior talent only when—and where—it adds demonstrable value. The result is a smoother path to proof of concept and a faster hand‑off to pivotal studies.

Clinical Operations Services

We provide proactive, end-to-end support on a comprehensive packet of clinical operation needs. Our clin op group orchestrates every moving part of a study while preserving data integrity and patient safety.

Highly Experienced Clinical Trial Monitoring

Monitoring is a critical component in the successful execution and oversight of a clinical trial. It involves verifying that data entered in the electronic data capture (EDC) system are accurate and consistent with the source data in the medical records at clinical sites. Monitoring also ensures that all study procedures and assessments are followed consistently through the life of the study and conducted in accordance with the approved study protocol.

The professionals responsible for these monitoring activities are known as Clinical Research Associates (CRAs), or monitors. CRAs serve as the primary point of contact for clinical site research staff, providing study guidance, oversight and support, while conducting both onsite and remote monitoring visits to ensure data integrity and protocol compliance. CRAs are the main and only constant site contact for each Sponsor; they emulate the culture, goodwill, and ethics of the industry.

Exact Clinical is a specialized consulting group with a team of senior-level CRAs, each with over 10 years of monitoring experience.  Our team provides high-quality, flexible monitoring services tailored to the needs of our clients, including:

  • Onsite and remote Site Qualification Visits (SQVs)

  • Onsite and remote Site Initiation Visits (SIVs)

  • Clinical site activation

  • Ongoing site management and communication 

  • Onsite and remote Interim Monitoring Visits (IMVs)

  • EDC data review and query resolution 

  • Onsite Close-Out Visits (COVs)

  • Investigational drug and Pharmacy oversight 

Exact support’s Phase I to Phase IV clinical trials across a range of therapeutic areas. Our services are designed specifically for biotech, small to mid-sized pharma companies, and academic sponsors conducted in North America.  

With a team of highly experienced CRAs strategically located throughout the country, Exact Clinical ensures your trials are executed with the highest standards of quality and regulatory compliance. As a boutique organization with minimal overhead, we are able to offer exceptional service at a more competitive price point than traditional CROs.   

  • I may work for the sponsor, but on site, I’m part of the study team. I love that sense of shared purpose — and SDV is how I help uphold the integrity of the entire trial.

    Sr. CRA, Irvine, CA

  • No matter how digital we get, nothing replaces the value of being on site — seeing the study in action, building trust with the site team, and verifying the data at its source. That’s where the real story of the trial unfolds, and I still love being part of it.

    Sr. CRA, Atlanta, GA

  • Being on site keeps me connected to the heart of the study. Source data tells the patient’s story and verifying it firsthand reminds me why our work matters.

    Sr. CRA, Chicago, IL

Why Choose Exact Clinical?

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

  • 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.

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Comprehensive Services

Experience Matters

Connect with Exact Clinical Research today and discover how strategic, experienced partners can move your next study forward with certainty.

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