Clinical research expertise, on demand
We have worked both sides of the trial. Now we work yours.
Clinical research professionals who have run study startup at academic cancer centers and activated sites for a global sponsor. We keep your trials moving and inspection-ready.
The clinical difference
Both sides of the table.
Our clinical research lead ran study startup at a top NCI-designated cancer center and a leading academic medical center, then activated sites for a global pharmaceutical sponsor. We know why sites stall and what sponsors need, because we have been the person stalling and the person asking.
One team that can translate between the two, and fix activation from both ends.
Site side
Academic medical centers and cancer centers
- Why a budget sits in Finance for six weeks
- Which ancillary committee quietly owns the critical path
- What a coordinator carrying five protocols actually needs from a sponsor
Sponsor side
Global pharmaceutical sponsor
- What leadership needs on a dashboard before funding another site
- What an incomplete essential-document package costs three steps downstream
- How ICF negotiation stalls across countries, and how to unstick it
And the rest of the model
Expert-led, not a pipeline
Big staffing firms send resumes. We are led by an operator who has run startup portfolios, trained teams, and built the SOPs. Every contractor is vetted and managed by her.
Fast to start, flexible terms
Engagements start in days. Contract, fractional, or fixed-scope project. No long-term lock-in and no permanent placement fees.
Whole-lifecycle coverage
Feasibility through close-out, not just one slice. We cover the full trial lifecycle.
Metrics-driven
We measure activation cycle time stage by stage, find the bottlenecks, and fix them.
Oncology depth, all-area coverage
Phase I through III across hematologic malignancies, BMT, GU, thoracic, gynecologic, neuro-oncology, and GI oncology, with non-oncology experience in infectious disease, behavioral, and medical physics studies.
Services
Organized by the trial lifecycle
Feasibility through close-out. Starred areas are where our hands-on depth runs deepest and where we lead.
Planning & Feasibility
Get ahead of delays before they start. We review your protocol for operational risks and help select sites that can actually enroll.
- Feasibility assessments and site selection support
- Protocol operational review: spotting regulatory, budget, contract, and institutional dependencies early
Study Startup & Site Activation
CoreOur deepest expertise. We run activation from feasibility through first-patient readiness, keeping every site on track.
- End-to-end activation from feasibility through site readiness
- Essential document collection and quality review
- Site regulatory packages and activation packages
- IRB/EC and ancillary committee submissions (radiation safety, institutional biosafety)
- Investigational product (IMP) release readiness
- Milestone tracking, risk escalation, and corrective actions
- Rapid activation programs for high-priority trials
Regulatory Affairs
CoreIND documentation, IRB submissions, and regulatory file maintenance that stays inspection-ready from day one.
- IND-related documentation, amendments, and annual reports
- IRB submissions, continuing reviews, and modifications
- Regulatory file and regulatory binder setup and maintenance
- Sponsor-investigator support for investigator-initiated trials
- ICH-GCP, FDA, and IRB/EC compliance guidance
Informed Consent
CoreConsent forms that patients can actually read, negotiated across sites without slowing you down.
- ICF writing and editing in plain language
- Site-specific ICF negotiation and harmonization across sites
- Budget/ICF harmonization workflows
Contracts & Budgets
Contract and budget roadblocks are one of the most common reasons trials open late. We clear them.
- Coordinating CTA and budget dependencies between sponsor, site, finance, and legal
- Removing contract and budget roadblocks that delay activation
Trial Conduct & Clinical Operations
Keep your trial running. Fractional study managers, monitoring, site coordination, and vendor oversight.
- Fractional or contract clinical trial and study managers
- CRA monitoring through our vetted network
- CRC support at sites
- CRO and vendor oversight
- CTMS data management, dashboards, and status reporting
TMF, Quality & Inspection Readiness
Your Trial Master File is your proof that the trial was run correctly. We keep it that way.
- TMF/eTMF setup, maintenance, health checks, and remediation
- Inspection-ready regulatory files
- Audit and inspection preparation support
- SOPs, work instructions, job aids, and training programs
Operations Improvement
CoreWe measure activation cycle time stage by stage, find the bottlenecks, and fix them.
- Activation cycle-time analysis: measuring time at each startup stage and finding bottlenecks
- Standardized tools: site-readiness checklists, regulatory review logs, escalation pathways
- Training and mentoring for startup and regulatory staff
Close-Out
Clean close-out with reconciled documentation and proper archiving.
- Site close-out support, final TMF reconciliation, and archiving
Who We Serve
Sites and sponsors, because we have been both
Each audience has its own page with the pain points we see, what we do about them, and the roles that fit.
Academic Medical Centers, Cancer Centers & Research Hospitals
Your teams are stretched thin, activation backlogs are growing, and high-priority trials need to open yesterday. We have sat in your chair.
How we help AMCs & Cancer CentersPharma & Biotech Sponsors
Thin internal teams, sites that activate late, and milestone pressure from investors and boards. We know what sites need from you to open on time.
How we help Pharma & BiotechContract Research Organizations
Surge demand for qualified staff, sponsor expectations for speed, and TMF quality under scrutiny.
How we help CROsIndependent Research Sites & Site Networks
Small teams wearing many hats. Regulatory submissions and budget negotiations are slowing everything down.
How we help Independent SitesRoles We Place
Clinical research professionals across the full trial lifecycle
Every role is available as contract or C2C, fractional, or project-based. No permanent placement.
Study Startup & Regulatory
- 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).
- Study Start-Up Manager
- Leads the full startup process for one or more studies, from site selection through activation. Sets timelines, manages the startup team, removes contract, budget, and regulatory roadblocks, and reports progress to leadership.
- 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.
- Regulatory Coordinator
- Prepares and maintains IRB submissions, regulatory binders, and essential documents at the research site.
- ICF Writer & Editor
- Writes and edits informed consent forms so they are accurate, easy for patients to understand, and compliant. Negotiates site-specific changes with hospitals and ethics committees.
- Feasibility Specialist
- Helps choose the right countries and sites by assessing whether they have the patients, staff, and resources to enroll successfully.
- Site Contracts & Budget Specialist
- Negotiates clinical trial agreements and budgets between sponsors and sites. Delays here are one of the most common reasons trials open late.
Clinical Operations
- Clinical Trial Manager
- Oversees a whole trial or program: budget, timeline, vendors, and study team, from planning through close-out.
- Clinical Research Associate (CRA)
- Visits sites, on-site or remotely, to verify data, patient safety, and protocol compliance.
- Clinical Trial Assistant (CTA)
- Supports the study team with document filing, CTMS tracking, meeting coordination, and records.
Site Staff
- Clinical Research Coordinator (CRC)
- Runs the study at the hospital or clinic: recruits and consents patients, schedules visits, collects data, and acts as the link between patients, doctors, and the sponsor.
Documentation, Quality & Data
- 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 Data Manager
- Makes sure trial data is accurate, complete, and ready for analysis. Resolves discrepancies with sites.
- Medical Writer
- Writes protocols, investigator brochures, clinical study reports, and other key documents.
- Clinical QA / GCP Auditor
- Audits sites, vendors, and processes against GCP and helps teams prepare for FDA and health authority inspections.
- Drug Safety / Pharmacovigilance Specialist
- Collects, reviews, and reports side effects and safety events so patients stay safe and regulators are informed on time.
Fixed-Scope Packages
Defined deliverables, defined timeline
Competitors rarely package this work clearly. We do. Each package is scoped with you before we start.
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.
How We Work
Three ways to engage
Common to all three: engagements start in days, month-to-month terms, no long-term lock-in, and one accountable point of contact. We do not offer permanent placement.
Contract / C2C staffing
A vetted clinical research professional placed in your team for a defined term, billed hourly. Direct or corp-to-corp through staffing partners.
Best for: Coverage, backfill, surge demand, and defined-term roles.
Fractional / embedded expert
A senior lead, such as a fractional study startup lead or clinical operations lead, who works inside your team part-time and scales up or down as needed.
Best for: Thin internal teams that need senior judgment without a full-time hire.
Project-based (fixed scope)
Defined deliverables on a defined timeline. See the fixed-scope packages below.
Best for: Activation sprints, TMF health checks, assessments, and inspection prep.
Track Record
Nearly every role we place, we have done
Our clinical practice is led by a practitioner, not a recruiter. The experience behind the network, in plain terms.
- More than a decade of clinical research experience across academic medical centers, a top NCI-designated cancer center, and a global pharmaceutical sponsor
- Phase I through III experience with an oncology specialty: Phase I, hematologic malignancies, bone marrow transplant, GU, thoracic, gynecologic, neuro-oncology, and GI oncology, plus infectious disease, behavioral, and medical physics studies
- Hands-on experience in nearly every role we place: CRC, regulatory coordinator, senior regulatory coordinator, study startup specialist, senior manager of study startup, and sponsor-side site activation specialist
- Managed and mentored startup managers and trained regulatory and startup staff
- Led a rapid activation program with a 45-day target
- Global multi-country site activation experience
- Expertise in ICH-GCP, FDA requirements, IRB/EC processes, IND documentation, and inspection readiness
- MS in Biotechnology with a Regulatory Affairs concentration from Johns Hopkins University
From the Blog
Operational writing for research teams
Coordinator turnover: keeping trials running when your CRC leaves
CRC turnover disrupts enrollment, data quality, and site compliance. Here's how to prepare for it, create handover documentation, and keep your trials running.
ReadWriting informed consent forms patients actually understand
Most informed consent forms are written for regulators, not patients. Here's how to write ICFs that meet regulatory requirements and are still readable.
ReadTMF health check: 10 signs your Trial Master File isn't inspection-ready
Is your Trial Master File inspection-ready? Here are 10 warning signs that your TMF has problems and what to do about each one before an auditor finds them.
ReadFAQ
Common questions
What does "both sides of the table" mean in practice?
Our clinical research lead spent most of her career site-side at academic medical centers and a top NCI-designated cancer center, then moved sponsor-side to activate sites for a global pharmaceutical company. That means we know why a site is slow from the inside and what a sponsor needs to see to move. We use both to fix activation from both ends.
Do you place staff at research sites, or only with sponsors and CROs?
Both. We staff CRC, regulatory coordinator, and study startup roles at academic medical centers, cancer centers, and independent sites as readily as clinical trial manager, CRA, and TMF roles at sponsors and CROs.
Are your clinical professionals GCP trained?
Every professional we place has current, documented GCP training (CITI or a TransCelerate-recognized program) and hands-on experience in FDA-regulated trials. We verify training and experience before anyone joins the network.
What therapeutic areas do you cover?
All therapeutic areas, with an oncology specialty: Phase I, hematologic malignancies, bone marrow transplant, GU, thoracic, gynecologic, neuro-oncology, and GI oncology. Our non-oncology experience includes infectious disease, behavioral, and medical physics studies.
Do you offer permanent placement or direct hire?
No. We work on contract and C2C staffing, fractional embedded leads, and fixed-scope projects. Engagements start in days, run month-to-month, and have one accountable point of contact.
How quickly can someone start?
Typically within days. Coverage and backfill roles, in particular, are designed to start fast with a documented handover on the way in and the way out.
Get Started
Need clinical research support?
Tell us about your trial, your sites, and your timeline. We will scope the role or the package.
For Professionals
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CRAs, CRCs, study startup, regulatory, and TMF professionals. Reviewed by a practitioner who has done your job.