A clinical operations team, without the payroll.
Design the team on the Service Value Added Model (SVAM) tiers, select the right FSP partner, and govern delivery, so you pay for work completed, not headcount.
Molecule to approval.For emerging biotech leaders who cannot afford to get the first trial wrong.
For startup biotechs and emerging life science companies, we structure smaller, sharper engagements. Fractional clinical development leadership, pre-IND audits, project sprints, and board advisory. The same principal who has architected Phase I-IV programs across 30 countries and 22+ therapeutic areas, scaled to where you are.
Discovery & Preclinical
Clinical operations input to the IND-enabling plan, before the first dollar goes to tox.
- Clinical development plan input
- IND-enabling roadmap review
- Clinical operations readiness
- Preclinical-to-clinical CRO selection
IND / CTA Submission
The first regulatory file is also your first credibility statement to acquirers.
- Pre-IND meeting prep
- Clinical sections coordination
- Regulatory pathway analysis
- Multi-agency strategy
Phase I FIH
First-in-human is where startup discipline either compounds or unravels.
- Protocol & endpoint design
- Site & CRO selection
- Dose-escalation governance
- Safety review setup
Phase II POC
The proof-of-concept that triggers the next financing round or partnership.
- Adaptive trial design
- Biomarker strategy
- Interim analysis framework
- Investor & partner readouts
Phase III Pivotal
This trial is your company's valuation. The principal has directed an $875M, 10,101-patient Phase III program.Each month of delay costs an approved drug about $24M in lost sales (Tufts CSDD, 2024).
- Pivotal protocol architecture
- FSP / CRO governance
- Risk-based monitoring
- End-of-Phase II / SPA
BLA / NDA Submission
Submission readiness is decided long before the filing date.
- CTD module strategy
- Pre-NDA meeting prep
- Clinical operations readiness for submission
- FDA, EMA, PMDA coordination
Phase IV / Post-Market
Approval is the start, not the finish. RWE shapes label expansion and payer access.
- Post-marketing commitments
- REMS architecture
- Phase IIIb / IV design
- Pharmacovigilance setup
RWE / RWD Programs
Beyond the label: market access, payer dossiers, and the data engine behind them. See the RWE Doctrine.
- RWE study design
- Data-lake architecture
- HEOR & payer evidence
- Registry & observational
Pick the shape that fits your stage and runway.
When the CRO Is Off Plan
For emerging biotech leaders whose first trial is slipping: enrollment behind, change orders climbing, or the CRO team turning over. One accountable advisor diagnoses the study and delivers a recovery plan your board and your CRO can both run.
- Voice of the Client (VOC) and Seven Pains sponsor diagnostic
- Change-order review against the original SOW
- Stage-Gate recovery plan with named owners
- CRO governance reset
See the one path every rescue follows.
Pre-IND Strategic Audit
Independent assessment of your IND-enabling roadmap, clinical operations readiness, and regulatory pathway choice before you commit to a tox program or an agency meeting.
- IND-readiness scoring
- Regulatory pathway recommendation
- CRO / partner shortlist
- 12-month operational roadmap
Fractional Clinical Operations Oversight
The most common startup engagement. We serve as your fractional clinical operations oversight lead, sitting in your weekly clinical operations meetings, your partner conversations, and your board updates.
- Clinical operations leadership
- Regulatory strategy oversight
- Vendor & CRO governance
- Board and investor metrics reporting
Targeted Project Delivery
Single-deliverable engagements for specific milestones. IND filing, pre-NDA prep, FSP architecture, Phase III protocol design, or an acquirer-readiness diligence audit.
- IND / CTA operational readiness
- Pivotal trial design
- FSP / CRO RFP & selection
- Acquirer diligence prep
Scientific & Clinical Advisory Board
Lighter-touch role for early-stage companies where the board needs a senior clinical operations voice but the trial work has not started. Often the first step before a fractional engagement.
- Board-level clinical advisor
- Quarterly strategic reviews
- Diligence call support
- Partner / investor warmup
A Clinical Operations Team, Without the Payroll
For emerging biotech leaders who need a full clinical operations function but cannot hire one. Clinical TrialRx designs the team on the SVAM tiers, selects and onboards the FSP partner, and governs delivery, so you pay for work completed, not headcount.
- Right-size the team on the SVAM ladder, staff augmentation to strategic partner
- FSP partner selection and onboarding
- SOW, KPIs, and budget built right the first time
- Stage-Gate governance and monthly metrics reporting to your board
FSP delivery model built twice: once for a national staffing and workforce services company, once as a sponsor's first FSP architect. See the one path.
Tell us where you are.We will tell you what we would do next.
Every advisory call begins with a 30-minute conversation: where you are, what is coming, and the two or three operational decisions that will most shape the next 12 months. No deck and no pitch.
If we are a fit, we will propose a path. If we are not, we will tell you who is.
Five engagement tiers. Scale as far as your program needs.
The twelve service lines on the Capabilities page can be deployed at any tier of engagement. The Service Value Added Model (SVAM) lets sponsors scale from targeted staffing augmentation through full strategic partnership, transparent upgrade paths, outcome-aligned pricing, bid commitments carried into delivery. For biotechs without an internal team, SVAM is also the blueprint for building an FSP from scratch.
Why SVAM exists: SVAM was developed while leading the FSP delivery practice for a national staffing and workforce services company, as it moved from staff augmentation to a true service-line model. The five tiers below are the path mapped then, and the path every sponsor can now follow.
Staffing
Targeted resource augmentation through the partner you select, with role specifications, vetting, onboarding, and performance metrics overseen by Clinical TrialRx.
- Interim CPM / TPM / Ops leads
- CRA / monitoring surge
- Regulatory & submission specialists
- Rapid deploy · 2–4 wk
Limited Service
Scoped functional deliverables, discrete work packages with defined SOW, timeline, and acceptance criteria.
- Start-up & site activation rescue
- Data-lock readiness reviews
- Amendment review and governance
- Risk-based monitoring oversight
Personnel
& Governance
Managed teams with embedded governance, the most common rescue entry point. Full-functional or cross-functional team under our delivery oversight.
- FSP team deployment
- Full CRO oversight & metrics
- Client Delight COE active
- Stage-Gate governance
Operational Partnership
End-to-end study or program delivery, trial rescue from diagnosis through data-lock, submission-ready evidence, and close-out.
- Accountable oversight of the full trial turnaround
- Portfolio-level PM-COE
- RWE/RWD COE standards
- Regulatory submission support
Strategic Partnership
Multi-program, multi-year, operating as the sponsor's extended clinical operations leadership with shared outcome accountability.
- Fractional CCO / Head of Ops
- Annual Operating Plan alignment
- Portfolio-wide delivery metrics
- Advisory & board-level support
Build it. Transfer it. Exit on schedule.
Start with one therapeutic area.
Many consulting engagements build and then stay. BTE is designed to exit. Build-Transfer-Exit (BTE) builds an AI/ML-enabled clinical operations capability that your team owns and runs, with Clinical TrialRx out of the building on a date written into the contract. It starts small, proves itself on your own numbers, and scales only when the results earn it.
4 to 6 weeks · Fixed scope
One therapeutic area's data-lock and start-up workflow mapped end to end, with the days and dollars being lost measured. The deliverable is a business case built on your own data.
About 6 months · One therapeutic area or one study
Build and Transfer run on a narrow scope. Days saved and costs avoided are measured against your baseline, and your team is trained and certified.
12 to 18 months · Only after the pilot proves out
Full Build-Transfer-Exit across the portfolio, scoped from the pilot's measured results. The IP transfers to your team, followed by a clean exit with an optional advisory retainer.
the Timeline
Avoided
a Month Sooner
Build
The principal, as accountable lead, working with your technology vendors or vetted engineering partners, architects the data-lock orchestration platform, integrated with your EDC, CTMS, eTMF, and PV systems. Deploy live in pilot therapeutic area. Co-author governance with sponsor's Head of Clinical Operations.
- AI/ML model architecture + training
- System integration & pilot TA live
- Governance framework co-authored
- Quarterly board reviews initiated
Transfer
Sponsor team trained, certified, and progressively assumes operations. Delivery moves from side-by-side, to shadowing, to fully handed off. IP transferred under sponsor ownership. Internal champions identified and elevated to platform leadership.
- Sponsor team trained & certified
- Operations handed off by TA
- Full IP transferred to sponsor
- Internal champions in platform lead roles
Exit
Sponsor owns and runs the system end-to-end. We provide quarterly advisory only. Time and cost results validated to the board, ROI measured, internal team fully autonomous. Clean exit with optional ongoing advisor retainer.
- Sponsor fully autonomous
- ROI validated to board
- Days and dollars measured against plan
- Optional advisor retainer only
Straight answers, before the first call.
When does an FSP model fit an emerging biotech?
When you need a clinical operations team without carrying the payroll. Clinical TrialRx designs the team on the SVAM tiers, selects and onboards the FSP partner, and governs delivery, so you pay for work completed, not headcount.
Can a startup biotech start with a small, fixed scope?
Yes. Engagements start small: a 30-day Biotech Rescue when the CRO is off plan, a 4 to 6 week Pre-IND Strategic Audit, or a monthly fractional clinical operations oversight retainer.
What does fractional clinical operations oversight include?
It is the most common startup engagement: on a monthly retainer, the principal serves as your fractional clinical operations oversight lead, sitting in your weekly clinical operations meetings, your partner conversations, and your board updates. It covers clinical operations leadership, regulatory strategy oversight, vendor and CRO governance, and board and investor metrics reporting.
Does Clinical TrialRx support pivotal Phase III programs?
Yes. The principal has directed an $875M, 10,101-patient Phase III program and has architected Phase I to IV programs across 30 countries and 22+ therapeutic areas.
Your trial is off-course.
We put it back on target.
Start with a no-obligation rescue assessment. We will diagnose where your program has drifted, map the VOC and Seven Pains failure points actively dragging it, and show you a governed path to recovery in 30 minutes.
Pittsboro, IN 46167