Clinical research support for Pharma & Biotech
Pharma & 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.
Your Challenges
What slows you down, and what we do about it
- Thin internal clinical teams without enough bandwidth
- Fractional study startup or clinical operations leads who run the work, not just advise on it.
- Sites that activate late and miss enrollment windows
- Site activation specialists who have worked site-side and know exactly where your package is getting stuck.
- Weak CRO oversight and accountability gaps
- CRO and vendor oversight support, including oversight documentation that holds up in an inspection.
- TMFs handed back incomplete at study close
- TMF management, health checks, and remediation before close-out, not after.
- Inspection readiness becoming urgent near submission
- Inspection Readiness Review and regulatory affairs support for the documentation behind your filing.
- ICH E6(R3) expectations raising the bar
- Risk-based quality and oversight documentation aligned to E6(R3), built into how your trial already runs.
- Investor and board milestone pressure
- Contract clinical trial managers and CRAs who start in days, plus dashboards leadership can actually read.
Roles We Place
Professionals who fit Pharma & Biotech
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.
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.
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.
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.
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.
Using cycle-time metrics to find activation bottlenecks
We tracked stage-by-stage cycle times across a multi-department activation portfolio, built dashboard reports, and surfaced the specific bottlenecks slowing study startup.
Read moreOncology: Phase 3Activating 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 Pharma & Biotech.
For Professionals
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