Scope
Pick EU countries where your trial will run.
Countries
Germany✓
France
Spain
Italy
Netherlands
Poland
Trial EU submission
drafted in 10 minutes
Go from protocol to fully drafted CTIS Part II documentation in minutes and save weeks of work for each EU country
- ✓Participant information
- ✓Informed consent form
- ✓Recruitment arrangements
- ✓Site suitability
- ✓Investigator suitability
- ✓Site contracts
Upload Protocol
AI Analysis
Submission plan
Download package
Protocol
Submission plan
Germany
PISICFSites
France
PISICFSites
Spain
PISICFSites
Italy
PISICFSites
Netherlands
PISICFSites
Poland
PISICFSites
Germany
Participant informationReady
Informed consent formReady
Recruitment arrangementsReady
Site suitabilityReady
Investigator suitabilityReady
Compliance statementsReady
文Multiple languages
◎Country-specific formatting
✓Robust expert-designed templates
⇩Download as editable Word (.docx) files
Designed to fit your trial
Trial agents draft trial documents that match your study design, drug modality, and therapeutic area.
- Aligned with the trial design and protocol
- Therapeutic-area-specific content
- Adapted for vulnerable & higher risk populations
Trial Design
Drug Modality
Participant Population
Therapeutic Area
Clinical Endpoints
I/E Criteria
Trial
Submission
Submission
Approved
DE
FR
ES
IT
PL
Patienteninformation und Einwilligung
Notice d'information et consentement
Hoja de información al paciente y consentimiento
Informativa per il paziente e consenso
Informacja dla pacjenta i zgoda
Built around CTIS country requirements
TrialAgents creates country- and language-specific CTIS Part II drafts using local templates and regulatory guidance.
- Country-specific CTIS formatting
- Cross-country consistency
- Designed for ethics committee and competent-authority requirements
How it works
From protocol to submission package in 3 steps
Pick your countries, review the AI's plan, and download fully drafted documents — country by country.
Protocol
TrialAgent analyzes your trial protocol and recommends a submission plan.
Study populations
● Adult participants — single dose● Adult participants — multiple ascending dose● Adolescents 12–17● Pregnant partners of participants● Healthy adult volunteers
Download
TrialAgent generates CTIS Part II document drafts for your trial.
Germany · 13 docs
Recruitment-arrangements_DE.docxComplete
PIS-ICF_adult-SAD_DE.docxComplete
PIS-ICF_adult-MAD_DE.docxComplete
PIS-ICF_parents_DE.docxComplete
PIS-ICF_adolescents_DE.docxComplete
Everything in your submission package
Per country, drafted in the local language, ready to download as editable .docx.
Participant-facing documents
Participant-facing documents
▤Subject information & informed consent for adult participantsIncluded
▤Subject information & informed consent for healthy adultsIncluded
▤Subject information & informed consent for parentsIncluded
▤Subject information & informed consent for adolescentsIncluded
▤Subject information & informed consent for childrenIncluded
▤Subject information & informed consent for pregnant partnersIncluded
▤Subject information for optional biosample collectionIncluded
▤Collection of biological samplesIncluded
Regulator-facing documents
Regulator-facing documents
▤Recruitment arrangementsIncluded
▤Site suitability formIncluded
▤Data protection statementIncluded
▤CV Principal investigatorIncluded
▤DoI Principal investigatorIncluded
▤Participant compensationIncluded
Custom templatesBring your own templates
A few examples: branded submission templates, site contracts, vendor / CRO contracts, statements of work, internal documents.
Pricing
Pricing
Choose the level of support your study needs. Every package is priced per country.
Personal
Individual submissions
€150per countryComplete CTIS package, generated by TrialAgents
- Complete Part II package
- All EU countries
- Local regulatory requirements
- Local-language documents
- Study & population tailoring
- Pre-signed NDA
Business
Sponsors & CROs
€390per countryTrialAgents + your organization's requirements
- Complete Part II package
- All EU countries
- Local regulatory requirements
- Local-language documents
- Study & population tailoring
- Pre-signed NDA
- Organization NDA
- Custom company templates
- Dedicated support
Full Service
Teams wanting a finished package
€1,200per countryAI generation + regulatory expert review
- Complete Part II package
- All EU countries
- Local regulatory requirements
- Local-language documents
- Study & population tailoring
- Pre-signed NDA
- Organization NDA
- Custom company templates
- Dedicated support
- Regulatory expert review
- Issues identified and resolved
- Final package checked against protocol & country requirements
| Package | PersonalIndividual submissions | BusinessSponsors & CROs | Full ServiceTeams wanting a finished package |
|---|---|---|---|
| Price | €150per country | €390per country | €1,200per country |
| Package approach | Complete CTIS package, generated by TrialAgents | TrialAgents + your organization's requirements | AI generation + regulatory expert review |
| Complete Part II package | ✓ | ✓ | ✓ |
| All EU countries | ✓ | ✓ | ✓ |
| Local regulatory requirements | ✓ | ✓ | ✓ |
| Local-language documents | ✓ | ✓ | ✓ |
| Study & population tailoring | ✓ | ✓ | ✓ |
| Pre-signed NDA | ✓ | ✓ | ✓ |
| Organization NDA | – | ✓ | ✓ |
| Custom company templates | – | ✓ | ✓ |
| Dedicated support | – | ✓ | ✓ |
| Regulatory expert review | – | – | ✓ |
| Issues identified and resolved | – | – | ✓ |
| Final package checked against protocol & country requirements | – | – | ✓ |
File control
Control over your files
Keep control of your CTIS document files and make final edits before submission.
Downloadable NDA
Available before protocol upload
Protocol deletion
Automatic deletion after document generation
File security
Security controls for your files
Full flexibility
Editable Docx downloads for full flexibility