Strategic. Experienced. Exact.
Pioneering the Flex CRO Model
Your trusted partner for tailored solutions to manage and advance your most complex clinical programs.
Why Flex Matters
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.
Comprehensive Services
Functional Service Provider (FSP) & Full‑Service Solutions
Every offering can be engaged à la carte or woven into an integrated program—giving you true FSP clinical services without compromise.
Clinical Strategy and Operations
Project Management (Single Studies to Full Programs)
Data Management & Biostatistics
Safety Oversight & Pharmacovigilance
GCP Quality Assurance, Inspection Readiness and Quality Systems
Regulatory Affairs – strategy, FDA and ex‑US authority engagement, eCTD dossier development, submissions, and ongoing lifecycle management
Medical Writing & Publications
Competitive Intelligence & Commercial Assessment
Proven Experience
Our senior leadership averages 25+ years each – which translates into broad and in-depth experience guiding successful INDs, NDAs, and BLAs across oncology, rare disease, neurology, infectious disease and more. The result: precise planning, proactive risk mitigation, and seamless execution from first‑in‑human through approval.
Who We Serve
We provide unmatched expertise, support, and guidance to biotechnology, pharmaceutical and other life science companies, including:
Emerging Biotech Companies navigating first‑in‑human studies
Small to Mid‑Sized Pharmaceutical Companies accelerating Phase 1‑3 development
Academic & Government Sponsors advancing investigator‑initiated research
Global Health & Non‑Profit Organizations bringing innovation to underserved regions
Investors & Venture Funds seeking due‑diligence insights
Medical Device & Combination Product Developers requiring multifaceted expertise
Specialty Service Providers & CROs needing overflow or niche consulting
Trusted by Innovators