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Clinical Operations

The Engine Room of Clinical Development

While the Chief Medical Officer defines what needs to be proven, Clinical Operations owns the how, where, and when — translating scientific strategy into human data across all four NEG+ device programs.

The ClinOps Mandate

Operational Excellence & Strategic De-risking

In a biotech startup, Clinical Operations carries a dual mandate: executing the current trial with precision while simultaneously ensuring the trial design is actually doable — before resources are committed. This is what separates a lean startup ClinOps function from its large-pharma counterpart.

Pillar 1

Operational Excellence

Executing the current study on time, on budget, and in full compliance with GCP/ICH standards. Every site activation day saved, every query closed faster, every protocol deviation prevented — these are the KPIs that protect the data package and company valuation.

Pillar 2

Strategic De-risking

Pressure-testing protocol feasibility before it's too late. ClinOps owns the Probability of Operational Success (POpS) — identifying whether a protocol is too complex for sites to execute or too demanding for patients to enroll, before the trial starts.

Core Functions

Four Pillars of the ClinOps Remit

01

Strategic Feasibility & Protocol Architecting

ClinOps architects the strategy — not just executes it. Owns POpS and identifies operational failure points before they become costly.

Key Responsibilities

  • POpS Assessment: Pressure-test every protocol element — enrollment rate assumptions, visit burden, exclusion criteria breadth — against real-world site capacity before lock.
  • Site & Country Strategy: For the NEG+ PMUT-NIRS PNB device, identify medical centers with both the patient volume and multimodal imaging infrastructure to support early feasibility studies.
  • Complexity Mapping: Translate the CMO's scientific vision into an operationally viable protocol — flagging elements that will delay First Patient In or drive dropout rates above acceptable thresholds.
  • Endpoint Operationalizability: Ensure primary endpoints (e.g., first-attempt nerve localization success ≥85%) are measurable, reproducible, and defensible to FDA reviewers at the IDE stage.

Key Responsibilities

  • CRO Selection & Oversight: In a lean startup, ClinOps doesn't just outsource — it provides high-touch oversight to keep CRO timelines aligned with aggressive milestone gates (e.g., STTR Phase I submission, August 2026).
  • IRT/Randomization Vendors: Manage randomization and trial supply systems to eliminate stock-out and dispensing errors before they trigger protocol deviations.
  • Central Lab Management: Coordinate biospecimen logistics, assay validation, and data transfer agreements for multisite studies.
  • Specialized Imaging Read-outs: For PMUT and NIR-based devices, manage niche imaging core labs that can validate sensor performance against gold-standard anatomical references.
02

Vendor Ecosystem Management

ClinOps is the conductor of the virtual model — orchestrating CROs, central labs, IRT, and specialized imaging vendors as a single aligned orchestra.

03

Study Start-up & Patient Access

Speed is the primary currency of a startup. ClinOps owns the critical path to First Patient In (FPI) — the single most important operational milestone before any data exists.

Key Responsibilities

  • Site Regulatory Packages: Gather, quality-check, and submit site-level documents for IRB approval — clinical protocols, investigator brochures, informed consent forms, and site qualification packages.
  • Investigator Training: Ensure all site personnel are protocol-trained, GCP-certified, and device-proficient before first patient screening.
  • Recruitment Strategy: Design a data-driven patient journey. For the NEG+ PNB device, map where pudendal nerve block procedures actually occur — L&D units, urogynecology outpatient suites, pain centers — to align enrollment projections with realistic site productivity.
  • FPI Timeline Management: Maintain the critical path from contract execution to first patient screened, with escalation protocols when site activation milestones slip.

Key Responsibilities

  • GCP/ICH Adherence: Ensure every trial procedure — consent, randomization, data entry, adverse event reporting — complies with Good Clinical Practice and ICH E6(R2) standards. Non-compliance jeopardizes the entire data package.
  • Risk-Based Monitoring (RBM): Implement centralized statistical monitoring to identify data trends and site-level anomalies before they become systemic failures or FDA inspection findings.
  • Query Management: Track and resolve data queries within target timelines to maintain a clean database for interim analysis and dose-escalation decisions.
  • Audit Readiness: Maintain trial master files (TMF) in a perpetual audit-ready state — because acquirers and licensors will conduct due diligence on the data package before any exit transaction.
04

Quality & GCP Stewardship

Biotech value is built on data integrity. If the data package is messy, the IPO or acquisition fails. ClinOps is the last line of defense.

Performance Framework

ClinOps KPI Summary

Each ClinOps function maps to a measurable key performance indicator that directly impacts trial success, investor milestone triggers, and company valuation.

Function Strategic Contribution Key Metric (KPI)
Project Management Keeps the clinical program on the critical path — directly tied to milestone triggers for Series A and STTR Phase II funding. Timeline Adherence
Site Management Builds above-trial relationships with top-tier PIs; converts KOLs into clinical champions for publications and conference presentations. Site Activation Time
Financial Oversight Manages burn rate of NIH SBIR/STTR grants and venture capital against milestone deliverables — protecting runway. Budget Variance
Supply Chain Ensures each device (PNB, Colpotomizer, POP-Q sleeve) is at the right site, qualified, and available at the right time for each patient visit. Stock-out Rate
Data & Query Oversight Ensures data is clean for interim analysis, dose-escalation decisions, and FDA pre-submission meetings — protecting the regulatory dossier. Query Resolution Time
Regulatory Logistics Coordinates site-level IRB, informed consent, and investigator file maintenance — the operational side of FDA/IDE compliance. IRB Approval Cycle
Recruitment Operations Closes the gap between projected and actual enrollment — the single biggest driver of trial delay and cost overrun at the early feasibility stage. Enrollment Rate vs. Plan
The Startup Model

ClinOps in a Startup vs. Large Pharma

In a large pharma company, ClinOps is often a siloed execution arm. At NEG+ Innovations, the ClinOps lead functions as a mini-COO for the clinical program — directly impacting company valuation by hitting the milestones that trigger the next funding round.

Large Pharma

Siloed Execution

  • Receives fully developed protocol from Medical Affairs or CMO office
  • Executes against pre-defined timelines set by steering committees
  • Escalates budget issues through multi-layer approval chains
  • CRO managed by dedicated vendor management department
  • Site activation measured in months; regulatory submissions handled by separate RA team
  • Audit readiness maintained by QA department; minimal ClinOps overlap
NEG+ Innovations — Startup ClinOps

Mini-COO for the Clinical Program

  • Co-architects the protocol with the CMO — owns POpS and feasibility assessment from day one
  • Sets and defends timelines directly tied to investor milestone gates and grant deliverables
  • Has direct P&L visibility on STTR/SBIR grant burn; flags variances immediately
  • Selects, contracts, and provides high-touch oversight of CROs — acts as primary CRO interface
  • Drives site activation as a competitive advantage; IRB submissions managed in-house with RA partnership
  • Owns TMF quality and audit readiness as a core function — protects data package for acquisition due diligence
NEG+ surgical team — precision clinical execution in the operating room
Clinical Execution
Precision in Every Procedure

NEG+ ClinOps integrates site-level rigor with startup agility — building the evidence package that converts regulatory milestones into acquisition-ready inflection points.

Program Application

ClinOps Across All Four NEG+ Programs

Every ClinOps function applies differently to each device program, reflecting distinct regulatory pathways, trial designs, and milestone gates. Here is how ClinOps maps to each program.

Device 1 · Surgical Access

Belotte Colpotomizer™

ClinOps priority: multicenter human factors validation and colpotomy time study. Site selection targets high-volume MIGS programs (>100 TLH/year). IRB and IDE coordination with Q-Sub FDA meeting preparation.

FDA 510(k) · FPI Target 2027
Device 2 · Pelvic Diagnostics

POP-Q AutoSense™

ClinOps priority: STTR academic partner site coordination, IRB approval, and REDCap survey logistics for Phase 0. Drives NICHD/NIBIB submission timeline. Manages POP-Q sleeve supply chain across multi-site EFS.

510(k) + SaMD · STTR Phase I 2026
Device 3 · Interventional Analgesia

Pudendal Nerve Block Device™

ClinOps priority: site identification for PMUT-NIRS cadaveric validation and IRB-approved EFS. Multi-specialty enrollment (OB/GYN, Pain, Anesthesia) demands tailored recruitment strategy per specialty group.

FDA 510(k) · EFS Target 2027
Device 4 · Intrapartum Monitoring

MUMS™

Milestone-gated: ClinOps engagement contingent on Q-Sub FDA outcome. Phase I FIH planning initiated at SBIR Phase I award. Site selection focuses on academic L&D centers with MFM research infrastructure.

De Novo / PMA · Milestone-Gated
Cross-Program

Data Integrity & TMF

Centralized trial master file architecture and risk-based monitoring protocol applies across all four programs. Single QMS framework (ISO 13485 / 21 CFR Part 820) ensures consistent GCP standards regardless of trial phase.

Ongoing · All Programs
Cross-Program

Grant & Milestone Management

ClinOps tracks STTR Phase I and SBIR Phase I deliverable timelines against investor milestone gates. Budget variance reporting integrates NIH grant burn with VC runway — protecting the capital efficiency story for Series A.

Ongoing · Investor-Facing

Interested in Clinical Collaboration?

We actively engage academic medical centers, urogynecology KOLs, and clinical research organizations aligned with our STTR and IDE programs.

Contact ClinOps Team View R&D Pipeline →