Phase I Clinical Trial Protocol: Safety and Tolerability of Eye Drops in Healthy Volunteers
Budget
This trial is estimated to require a total budget in the range of **$250,000–$300,000**. The
following table outlines the primary cost categories with estimated expenses:
Category
Estimated Costs (USD)
Description/ Notes
Study Personnel
$75,000
Costs covering the Principal
Investigator (PI), clinical
research coordinator, data
manager, study nurses, and
support staff. Estimated for trial
duration.
Investigational Product &
Clinical Supplies
$50,000
Manufacturing and formulation
of three concentrations of
Ubiquinol eye drops,
packaging, labeling, and
related supplies such as
disposable equipment.
Participant Recruitment &
Screening
| $30,000
Recruitment materials,
advertising, screening
procedures (including
ophthalmologic exams and
blood tests), and participant
compensation.
Clinical Site Costs & Monitoring
$40,000
Expenses related to site fees,
regular monitoring visits, data
recording systems, and
oversight during patient visits.
Regulatory & Ethical Fees
| $10,000
IRB submission fees,
regulatory submission costs,
and Data & Safety Monitoring
Board (DSMB) related
expenses
Data Management & Statistical
Analysis
$20,000
| Data collection system setup,
database management, and
statistical analysis support.
Overhead & Administrative
Costs
| $20,000
| Institutional overhead,
administrative support, and
other related costs.
Contingency (Unexpected
Costs)
$15,000
Reserved funds to handle
unanticipated expenses (e.g.,
additional monitoring visits or
supply issues).
Total Estimated Budget
$260,000
This figure represents an
overall estimation and may be
adjusted based on final
negotiations, cost
confirmations, and funding
availability.
Budget Justification
Study Personnel
Investigational Product & Clinical Supplies
Participant Recruitment & Screening
Clinical Site Costs & Monitoring
Regulatory & Ethical Fees
Data Management & Statistical Analysis
Overhead & Administrative Costs
Compensation accounts for the portion of
effort contributed by research staff over the
trial period. It covers salary support for
project management, clinical assessments,
and data management.
This includes costs associated with sourcing
high-quality Ubiquinol, formulation
optimization for ocular delivery, and ensuring
Good Manufacturing Practice (GMP)
compliance.
To ensure a smooth recruitment and
screening process, funds are allocated for
advertising, consent processes, and essential
diagnostic tests.
Clinical sites must be adequately equipped
for patient visits and adverse event
monitoring. This category also covers travel
costs for on-site monitors and periodic
auditing.
The trial’s ethical integrity is maintained via
IRB oversight and adherence to regulatory
submissions.
A robust data management system is crucial
for safely collecting and analyzing clinical
data, supporting both safety and preliminary
PK/efficacy assessments
Institutional fees cover administrative
support, trial coordination, and facility-related
costs.
Contingency
A reserve is necessary for any unforeseen
circumstances that may arise during the trial.