Clinical research support for CROs
Contract Research Organizations
Surge demand for qualified staff, sponsor expectations for speed, and TMF quality under scrutiny.
Your Challenges
What slows you down, and what we do about it
- Surge demand for CRAs and startup staff
- Contract and C2C startup specialists, regulatory coordinators, TMF specialists, and CRAs from a vetted network, ready in days.
- Sponsor pressure on site relationships and activation speed
- Site-relationship repair and activation support from people who have been the site contact on the other end of the call.
- Proving TMF quality and sponsor oversight
- Project-based TMF QC and sponsor-oversight documentation that survives a sponsor audit.
Roles We Place
Professionals who fit CROs
Clinical Research Associate (CRA)
Visits sites, on-site or remotely, to verify data, patient safety, and protocol compliance.
Study Start-Up Specialist
Gets trial sites ready to enroll patients. Collects and reviews essential documents, prepares IRB/EC submissions, tracks approvals, and coordinates with sites so each one opens on time and in compliance with Good Clinical Practice (GCP).
Regulatory Affairs Specialist
Handles communication and paperwork with regulators such as the FDA. Prepares and submits applications (such as an IND), amendments, and annual reports, and keeps the trial compliant from start to finish.
TMF Specialist
Manages the Trial Master File (TMF), the official record that proves a trial was run correctly. Keeps it complete in the eTMF system, runs quality checks, and prepares for audits and inspections.
Clinical Trial Manager
Oversees a whole trial or program: budget, timeline, vendors, and study team, from planning through close-out.
Clinical Trial Assistant (CTA)
Supports the study team with document filing, CTMS tracking, meeting coordination, and records.
Fixed-Scope Packages
Defined deliverables when you need an outcome, not a headcount
Site Activation Sprint
Full startup support for one or more sites through activation.
Regulatory Start-Up Package
Regulatory binder, IRB/EC submission, and essential documents, quality-checked.
ICF Development & Harmonization
Plain-language consent form plus site-specific negotiation across your trial sites.
TMF Health Check
Completeness and quality review of your Trial Master File with a remediation plan.
Inspection Readiness Review
Gap assessment of regulatory files and TMF before an audit or inspection.
Activation Cycle-Time Assessment
Stage-by-stage analysis of your startup timeline, the bottlenecks, and a fix-it plan.
Coverage & Backfill
A time-boxed regulatory coordinator or CRC for leave coverage or open roles, with a documented handover.
Fractional Clinical Lead
A senior startup or clinical operations lead, part-time, embedded in your team.
From Our Team's Experience
Related work
Work our clinical research lead has led in prior roles, presented to show the depth behind the practice.
Activating sites for a global Phase 3 oncology trial
We led multi-country site activation for a Phase 3 trial in a hard-to-treat gastrointestinal cancer, building reusable startup standards along the way.
Read moreMulti-therapeutic area trialsBuilding startup standards for a global sponsor
We built scalable startup tools and standardized processes for a global pharmaceutical sponsor, improving consistency and issue resolution across countries and studies.
Read moreGet Started
Need clinical research support?
Tell us about your trial and timeline. We will scope support sized for CROs.
For Professionals
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Experienced clinical research professionals. Tell us about your background.