Clinical trial software for Munich and Martinsried biotech
A small team with a first-in-human study to open does not need a six-month EDC procurement. Capture is a self-serve EDC hosted in Frankfurt that you can build and test free before the first dose.
- Hosted in Frankfurt, EU
- No enterprise contract to start
- Free sandbox
Free sandbox · No credit card · 21 CFR Part 11 compliant
Study region
Munich area, Germany
- Typical start
- First-in-human or Phase 1 / 2a
- Team
- 2 to 10 people, no dedicated IT
- Authorities
- BfArM or PEI, plus ethics committee
- Data law
- GDPR, BDSG and Bavarian supervision
- Hosting region
- EU (Frankfurt), chosen at study setup
Key points for a Munich-area biotech
- The Munich region, with its life-science campus at Martinsried south-west of the city, is one of Germany's densest clusters of early-stage biotech. Public sources describe university institutes and an incubator on site; confirm current details locally.
- Typical needs are small: a first-in-human or Phase 1 study at one or two sites, a lean clinical team, and an investor timeline that does not wait for software procurement.
- German studies face close data protection scrutiny and an authority plus ethics committee review. Read clinical trial software in Germany for the authorities; this page does not repeat them.
- Capture is hosted in Frankfurt, is ISO 27001 certified and GDPR compliant. It has no Munich office, partner or local data centre.
- Language support is not claimed here. Ask us before you plan German-language participant screens.
The local picture
What a hub biotech really needs from its EDC
Companies spun out of nearby universities and research institutes usually reach the clinic with a lean team, a small number of clinical sites and a financing round that funds one study at a time. The clinical operations person is often also the data manager, and the biostatistician is a contractor. For that team the useful EDC is the one they can configure themselves in days, test with realistic data, and hand to a site without a training programme.
Capture is built for that pattern. Upload the protocol and the AI study builder drafts the visit schedule and forms for your review. Nothing is saved without a human check. Then add edit checks that raise auto-queries when a site enters an out-of-range value, calculated fields such as QTcF and eGFR for the safety assessments an early-phase study leans on, and a blank eCRF PDF for the ethics submission. See EDC for first-in-human studies and EDC for Phase 1 clinical trials.
Two cities, one pattern
Other European hubs face the same constraint of a thin team and a fixed runway. Our Basel biotech page and the DACH overview cover neighbouring markets, which matters if a study will later add Swiss or Austrian sites.
- IRB/EC approved12-Aug-2026
- Contract executedConfirmed
- Site initiated / SIV completed02-Sep-2026
- Delegation log completeConfirmed
Pre-launch readiness
1 site activated
1 form not yet approved
Speed to first participant
Where a lean team loses weeks, and what removes the delay
| Typical delay | Why it happens | What removes it | In Capture |
|---|---|---|---|
| EDC procurement | Sales cycle, contract, security review | Self-serve start; reviewer tests the product directly | Free sandbox; ISO 27001 certificate and other documents on request. |
| Form build | Vendor builds from specification | Team builds from the protocol | AI drafts visits and forms; human review before saving. |
| Ethics package | Needs blank CRFs and consent | Export from the same system | Blank eCRF PDF; eConsent templates. |
| Site start-up | Training and accounts | Simple roles, one portal per site | Site coordinator portal, site-level numbering, QR enrolment. |
| Safety review | Out-of-range values found late | Checks at entry | Edit checks raise auto-queries; AE and lab forms. |
| Data for the statistician | Manual dataset work | Standard exports | CSV/Excel with data dictionary; SDTM as SAS XPT with Define-XML. |
Timelines depend on your protocol, sites and the authorities. This table shows where software typically adds or removes steps, not a promise of weeks saved.
Set up the study before the first site meeting
Upload the draft protocol to the free sandbox, review the generated forms and walk the investigator through them.
Data protection
Answering the German data protection questions early
Hospital data protection officers and ethics committees in Germany ask where data is stored, which sub-processors are involved and who can see identifying data. Capture hosts in Frankfurt when EU hosting is chosen, segregates names from study data, and gives sponsor users coded IDs. Data is encrypted with AES-256 at rest and TLS in transit. A data processing agreement is available on request.
Which supervisory authority applies to a Bavarian company or to a university hospital depends on the type of body, so ask your data protection officer rather than assuming. Pseudonymised data is still personal data, so document the key holder. See GDPR compliant clinical trial software and the GDPR DPIA template.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
A first-in-human plan
From draft protocol to first dose with a small team
- 1
Draft forms from the protocol
Upload PDF, DOCX or DOC. Review visits, vital signs, ECG, labs and adverse events.
- 2
Add checks and calculators
Edit checks for safety ranges, QTc and eGFR calculators, per-field source data verification where your monitoring plan needs it.
- 3
Dry-run with the investigator
Enter fake participants in the sandbox, including a failed screening and a serious adverse event.
- 4
File and go live
Submit the blank eCRF PDF, approve the forms to lock them, then enrol the first participant at the site.
Before the first site
Hub biotech checklist
Protocol and data list
A near-final protocol and a one-page variable list.
Authority and ethics route
Confirm the German authority and committee with your regulatory lead. See clinical trial software in Germany.
Vendor file
ISO 27001 certificate, validation package and data processing agreement, all available on request.
Roles
Investigator, coordinator, monitor and sponsor accounts, with two-factor sign-in turned on for staff. See multi-factor authentication in EDC.
CRO plan
If a CRO will monitor, share the sandbox early so they can review the forms.
Does Capture have an office or data centre in Munich?
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia) and has no Munich office, partner or local data centre.
Is Capture suitable for a first-in-human study?
Yes. Capture suits Phase 1 to Phase 3, with edit checks, calculated safety fields, adverse event forms and a blank eCRF PDF for submission.
Do we need a sales call or contract to start?
No. You can sign up, build and test a full study in the free sandbox. You pay only once you go live with real participants.
Can participants use German-language screens?
This page does not claim multilingual questionnaires or consent. Contact us about current language support before you plan German-language screens.
Which German authority reviews our trial?
It depends on the product type and study design, with the BfArM or the Paul-Ehrlich-Institut plus an ethics committee. See our Germany page and confirm with your regulatory lead.
Is the platform GDPR compliant?
Yes. Capture is GDPR compliant, can host in Frankfurt, and offers a data processing agreement. Your own data protection documentation still needs to describe your use.
Can a CRO work in the same study?
Yes. Add CRO monitors and data managers as users with role-based access, and every change they make carries their identity in the audit trail.
Keep exploring
Related pages
Clinical trial software in Germany
Authorities, ethics and GDPR.
Clinical trial software in DACH
Germany, Austria and Switzerland.
Clinical trial software for Basel biotech
A neighbouring biotech hub.
EDC for first-in-human studies
Early-phase safety data.
EDC for Phase 1 clinical trials
Lean Phase 1 set-up.
Best EDC systems for small biotech
What to compare.
Pricing
Free sandbox.
Open your first study in the free sandbox
Draft the forms from your protocol and test them with your investigator before any fee.