Visit 4 · Day 28 ± 2
v7 or v8?
Intelligent infrastructure for clinical trials
Trials don’t stall on science. They stall in the gaps.
Between teams, documents and systems, a trial’s decisions get copied, re-keyed and lost. Trialynx carries every one of them in a single, unbroken thread, from synopsis to first patient in.
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Winner · 2026 Idol Disrupt -
Winner · 2026 SCOPE × TransCelerate Digital Protocol Review Challenge -
Semifinalist · 2026 Life Science / Health IT
01 · The gap
One trial. Dozens of documents. Hundreds of handoffs.
Every copy-paste is a chance for the story to split. Every departure takes a decision’s reasoning with it. Every late change ripples into files nobody remembers to update.
0 inconsistencies found
Visit 4 · Day 30
Mismatch
Primary endpoint · Week 12
Protocol says Week 16
Visit 4 cost · #REF!
Broken link
52 replies · 9 people
Decision unclear
Blocked on final protocol
6 weeks idle
Rationale: see Sarah
Sarah left in March
02 · The turn
Now pull the thread. Everything falls into line.
Trialynx builds your study as structured data first, so every document is generated from the same source. Protocol, consent, SAP, budgets and the EDC build stay aligned, and every decision keeps its reasons, even as people, plans and vendors change.
- Scientific rigor
- Operational feasibility
- Aligned documentation
- Digital data flow
03 · What makes Trialynx different
Build the digital trial, not just the protocol.
One study definition becomes the foundation for everything your trial needs to run, from the science to the operations that execute it.
Single source of truthOne study definition
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Science
- Protocol
- Statistical analysis plan
- Sample size and power
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Operations
- Budget
- Timeline
- Enrollment plan
- Vendor evaluation and selection
- Sample management
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Oversight
- Clinical monitoring plan
- Data management plan
- Data and safety monitoring plan
- Quality and risk management plans
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People
- Informed consent
- Site forms
- Participant burden
- Site burden
- ICH M11 compliant
- USDM standard format
The pitch that won DPHARM Idol Disrupt 2026
“The industry and the FDA are moving toward real-time clinical trials, and you cannot run a real-time trial on paper.”
Trialynx aligns with the CDISC USDM and ICH M11 protocol standards, the digital foundation for the real-time trials the FDA is now piloting.
Idol Disrupt · Winner 2026
Chosen by a panel of 12 judges from six finalists at the 16th annual DPHARM conference in Boston.
Read the announcement ↗ 04 · The thread
From synopsis to first patient in. Nothing re-typed. Nothing lost.
01
Synopsis
Start from a one-page idea. Trialynx turns it into a structured study you can build on.
Idea → structure02
Evidence
References surfaced from ClinicalTrials.gov and PubMed. Every design choice keeps its rationale.
Rigor, recorded03
Feasibility
Patient burden, site burden and cost are scored while the design is still easy to change.
Risk, found early04
Documents
Protocol, consent, IB, SAP, monitoring plans, budgets and 25+ site forms. 90% complete first drafts, all aligned.
20+ documents05
Data
Structured study data flows into EDC and CTMS setup. Nothing is typed twice.
Digital data flow06
Change
Amend once and every document and system follows. The thread holds, even when the team changes.
Continuity05 · Continuity, demonstrated
Change it once. Watch it change everywhere.
Your study design is data, not prose. Try it: edit the source and see what follows.
Study design · single source of truth
0 updates · 0 copy-paste
Visit 4 occurs on Day 28 (± 2 days)
Participants aged 18 to 65 years
Your fourth visit is about 4 weeks
You must be 18 to 65 years old
V4 window D28 ±2
Screening age 18–65
V4 stipend scheduled D28
Eligible range 18–65
VISIT4 TARGET_DAY=28 WIN=2
IE01 AGE BETWEEN 18,65
Time on study 11.2 h
Population 18–65
Official Study TitleSource of truth
- ICH M11 Protocol 2 places · Draft
- Title page
- ICH M11 §1.1 Protocol synopsis
- Diversity Action Plan 3 places · Draft
- Title page
- Signature page
- ICH M11 §1 Study overview
- Statistical Analysis Plan 2 places · Draft
- Title page
- ICH M11 §1 Introduction
- Informed Consent 1 place · Draft
- Title page
- Clinical Monitoring Plan 2 places · Draft
- Title page
- ICH M11 §1 Scope
- Investigator’s Brochure 2 places · Draft
- Title page
- Signature page
- Quality Management Plan 2 places · Draft
- Title page
- Signature page
- Risk Management Plan 2 places · Draft
- Title page
- Signature page
- Project Management Plan 2 places · Draft
- Title page
- Signature page
- Data & Safety Monitoring Plan 2 places · Draft
- Title page
- Signature page
- Data Management Plan 2 places · Draft
- Title page
- Signature page
- Protocol Summary 1 place · Draft
- Title page
06 · Document Impact Explorer
Every document a change touches, mapped instantly.
Change one fact in the study definition and see every document and section it affects, so your team reviews what changed instead of rereading everything.
Explore the platform →07 · Choose your lens
Six seats at the table. One shared thread.
CEO · Founder · President · CFO
“Will this get us to data before the money runs out?”
Get to data before the runway ends.
What keeps you up
- Every month of delay is a month of burn without a readout
- Amendments nobody saw coming, each one costly and avoidable
- Weeks of billable document work that should take days
What changes
- Synopsis to an aligned study package in days, not months
- Operational risk surfaced before the protocol is final
- Do it yourself, or have our experts deliver it for you
CMO · CSO · Head of Clinical Development
“Will this make the science stronger, or just faster?”
Every decision, with its reasons attached.
What keeps you up
- A protocol that is elegant on paper and impossible to enroll
- Design rationale buried in someone’s inbox when the FDA asks why
- Protocol, IB, consent and SAP quietly disagreeing
What changes
- Evidence from ClinicalTrials.gov and PubMed behind every choice
- Rationale captured and preserved for every design decision
- AI proposes. Your experts decide. Everything is recorded.
VP Clinical Ops · Head of Study Startup
“Will this finally stop the fire drills?”
Change it once. It changes everywhere.
What keeps you up
- Twenty documents kept in sync by copy-paste and hope
- “Which version is final?” and fifty-reply email threads
- Site burden discovered after finalization, then the amendment
What changes
- The protocol becomes data; every downstream document follows it
- Decisions survive turnover, vendor handoffs and amendments
- Fits around your team, templates and systems. No rip-and-replace.
CEO · COO · Head of Medical Writing
“Can we deliver more studies with the same team?”
Your experts, multiplied.
What keeps you up
- Scarce, expensive writers and demand that never arrives evenly
- Bids lost to faster competitors
- Fixed-fee margin eaten by rework and avoidable amendments
What changes
- Your templates and SOPs, generated in perfect alignment
- First drafts that are 90% complete, so experts spend time on judgment
- A partner model that strengthens your offering in every bid
Site Network CEO · Research Director · Dean
“Can our investigators run their own research?”
Turn your investigators’ ideas into running studies.
What keeps you up
- Great ideas that die waiting for a protocol, budget and consent
- Sponsor protocols that overload sites and patients
- Lean research offices and constant coordinator turnover
What changes
- From idea to fundable, launch-ready study, with experts on call
- Patient and site burden treated as first-class design inputs
- Real-time collaboration across roles and institutions
CIO · CDO · Head of Clinical Innovation
“Does this make our data stack stronger, and is it safe?”
The protocol stops being a document. It becomes infrastructure.
What keeps you up
- The source of all study data still lives in a Word file
- Every downstream system re-keyed by hand
- Confidential protocols pasted into public chatbots
What changes
- Structured, reusable study data that flows to EDC and CTMS setup
- Your data is never used to train AI models
- Encrypted, sandboxed and role-based, built on ICH, NIH and FDA frameworks
08 · Proof
0
customized protocols delivered
0%
faster first drafts
0%
fewer draft revisions
0h
to first draft
“Trialynx can transform clinical trials by turning fragmented, document-based study design into an intelligent, structured digital workflow that enables faster, better-informed and more efficient trials.”
“We completed 56 fully customized protocols and our trials launch weeks ahead of schedule.”
“It makes building studies and writing documents effortless. I wish I’d had it earlier; it would’ve saved me countless hours.”
Trusted by teams at
09 · However you work
Bring us in, or bring it in-house. The thread holds either way.
Tech-enabled services
Our experts build it with you
Discovery, study design and the full document package, delivered in days by clinical research experts running on Trialynx. No large internal team required.
Explore services →The platform
Your team, supercharged
Design, collaborate and generate in real time with your own templates and SOPs. Your team keeps full control; Trialynx keeps everything aligned.
Explore the platform →Built for the people who have to defend it
- No model trainingYour data never trains AI models. Ever.
- Human in commandAI proposes. Your experts review, decide and sign off.
- Decision trailEvery choice keeps its rationale, ready for review or inspection.
- EncryptedAES-256 at rest, TLS 1.2 or higher in transit.
- Role-based accessSandboxed workspaces. People see only what they need.
- Standards-alignedBuilt on ICH, NIH and FDA frameworks from day one.
Patients are waiting.
Angie Schwab, Founder & CEO
Let’s take the gaps out of your next trial.