CTMS for small biotech
Clinical trial management software (CTMS) for small biotech companies
A small team, a first or second clinical program, and no time for a long software project. Protocol AI turns your protocol into a reviewed plan with tasks, milestones and owners, so the team can focus on the study.
1 · Extracted
Visit 3, Day 28 ± 3 days
§6.2, p. 42Approved12-lead ECG at Visits 1, 3, 6
§6.4, p. 45ApprovedPK sample, 2 h post-dose
§7.1, p. 51Needs review
2 · Study plan
Wk 0 to 80Site activation, 3 sites
CPM
First patient in
Sites
Visit 3 window tracking
CRA
PK sample logistics
Lab
Interim data review
DM
The reality
Clinical trial management challenges for small biotech companies
Small biotech companies often run clinical programs with a few operations staff, an outsourced CRO and a lot of spreadsheets. The same people plan the study, track vendors and report to the board.
Enterprise CTMS platforms are built for large sponsors. They can take months to configure and expect a dedicated team to run them.
Protocol AI starts from the protocol you already have. Your team reviews the extracted plan, approves it, and works from it, without building a system from scratch.
The problem
Clinical trial management without unnecessary complexity
When the runway is finite, every month of delay matters.
Start-up is long
Sites report an average of 31.4 weeks from site identification to study start-up.
Source: WCG, Decoding the Top Site Challenges of 2024: Study Start-Up (2024)
Amendments are costly
A substantial amendment has a median direct cost of about $141,000 in Phase II and $535,000 in Phase III.
Delay adds up
Direct trial costs are estimated at about $40,000 per day for Phase II and III studies.
What you get
Simplify clinical study planning
Early access capabilities for small sponsor teams. Roadmap items are confirmed per customer.
AI-assisted clinical protocol planning
Visits, windows, procedures and milestones pulled from the protocol, each with a section and page reference for review.
Manage clinical trial tasks and milestones
Every task has an owner, a due date and a status, tied to the milestones in the approved plan.
Improve clinical operations visibility
One view of progress, risks and deviations that the whole team and your CRO can see.
Budget tracking
A starting budget view tied to the plan, so cost and timeline questions come from the same source.
Guided onboarding
We set up the first study with you, starting from your protocol, instead of handing over an empty system.
Board reporting views
RoadmapProgram-level summaries suitable for board and investor updates.
How it works
From protocol upload to a reviewed study plan
Automation does the first draft. People make every decision that matters.
01
Upload the protocol
Start from the approved protocol PDF or Word file. Or hand it to our team during guided onboarding. No blank setup and no retyping the schedule of activities.
02
AI pulls out the study details
Visits, windows, procedures, eligibility points and milestones are pulled out, each linked to the section and page it came from.
03
Your team reviews and approves
A project manager or clinical lead accepts, edits or rejects each item. Nothing enters the plan without a named reviewer.
04
The study plan is generated
Approved items become a timeline, a task list with owners and a starting budget.
05
Run the study in one place
Track tasks, milestones, risks, issues and deviations as the study moves, with a history of who changed what.
Generated automatically
Draft extraction of visits, windows, procedures and milestones, each with a protocol section reference, plus a draft timeline and task list.
Requires human review
Every extracted item, every task owner and date, and the approved plan itself. Nothing is used until a named reviewer approves it.
Fit
Why small biotech teams should explore Protocol AI
Practical for teams without a dedicated clinical systems function.
- Pricing scaled to your study, with no long implementation project.
- Works beside your CRO and its systems.
- Plans stay linked to the protocol, which makes amendments easier to handle.
- Clinical operations services from the same team when you need extra hands.
Compliance
Documentation and compliance, stated plainly
Protocol AI keeps an audit trail of changes with user and time, limits access by role, and links every extracted item to its source in the protocol. It is designed to support 21 CFR Part 11 controls and the sponsor oversight expected under ICH E6(R3), showing who approved each part of the plan.
Compliance also depends on your procedures, so formal system validation is completed with each regulated customer rather than claimed in advance. Read the security and compliance overview for details.
FAQ
Frequently asked questions
Is Protocol AI too much system for a single study?
No. It is priced per study and set up from your protocol, so a single study is a normal starting point.
How long does it take to get started?
Onboarding is guided per study. The first step is uploading the protocol and reviewing the extracted items with your team, which we walk through together.
Is Protocol AI 21 CFR Part 11 compliant?
Protocol AI is designed to support 21 CFR Part 11 controls, including audit trails, role-based access and attributable changes. We do not claim validated or Part 11 compliant status. Before regulated use, validation and controls are assessed and agreed with you for your intended use.
How much does Protocol AI cost?
Pricing depends on your study, number of sites and the support you need. Book a demo or contact us and we will send a clear quote.
See your own protocol turned into a plan
Bring a protocol, or use our sample study. In 30 minutes you will see the extracted schedule, the generated plan and what your team reviews before anything goes live.