Key capabilities include:

  • Clinical Trial Management – central command of planning, resource allocation, timeline control, and cross‑functional oversight across Phase 1–4 programs.

  • Site & Investigator Identification / Qualification – data‑driven feasibility, infrastructure checks, and performance history reviews to secure high‑performing sites.

  • Study Start‑Up – contracts, regulatory outsourcing for IRB/EC and FDA submissions, vendor selection, and system activation—positioning us as your fast trial startup CRO.

  • Investigator Meetings & Site Training – engaging site(s) and personnel, protocol‑specific sessions that embed GCP fundamentals and unify study conduct across multiple sites.

  • Contract & Budget Negotiation – transparent, early engagement, institution‑aligned terms launched early to keep finances off the critical path.

  • EDC Configuration & Data Management – CRF design, system validation, user training, real‑time data issue resolution.

  • Study Monitoring – senior CRA‑led on‑site and remote strategies calibrated to address the risk profiles and country requirements of each trial.

  • Site Management & Patient Recruitment – proactive recruitment tactics to keep enrollment on track, ongoing site staff engagement, and KPI dashboards to hit milestones.

  • Investigational Product (IP) Management – supply forecasting and inventory management, shipping logistics, unblinded oversight, and destruction protocols.

  • Trial Master File (TMF) Management – eTMF system set-up and management, inspection‑ready, real‑time documentation stewardship from first document to archival.

  • Study‑Specific Plans – monitoring, safety reporting, risk mitigation, data management, communications plans, and more tailored to each protocol.

  • Clinical Document Development – high-quality authoring and QC of clinical protocols, ICFs, IBs, DSMB charters, study manuals, training materials and more.

  • Vendor Management – selection, contracting, and performance oversight for all project vendors (e.g. central and specialty laboratories, home visit nurses, drug packaging and distribution provider, etc.) and other specialty vendors.

Clinical Operations

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 Functional Service Provider (FSP) clinical services or fully integrated program oversight, our approach stays the same: Strategic, Experienced, Exact. 

A Trusted Biotech and Biopharma FLEX 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 service provider 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.

WHAT SERVICES DO I RECEIVE?

We provide proactive, end-to-end support for comprehensive clinical strategy and operations needs. Our seasoned clinical group can orchestrate every moving part of your study while preserving data integrity and patient safety.


Expert Talent, Seamless Execution

Every trial is personally staffed by leaders who average 20+ years in therapeutic‑area execution and global submission delivery. Their depth of knowledge empowers us to spot red flags before they escalate, align stakeholders quickly, and maintain the scientific spirit that sparked your program in the first place.

Advancing your next study may not be an exact science, but it CAN be an  “Exact” journey!

From first‑in‑human proof of concept trials to large, multi‑center Phase 3 pivotal studies, Exact Clinical Research stands ready to flex. Discover how our strategic guidance, proven operational expertise, and unwavering commitment to partnership can keep your clinical program on time, on budget, delivered with high quality, and on the path to approval.

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Strategic. Experienced. Exact.