Clinical trial software for women's health research
Cycles, pregnancy, postpartum and menopause studies depend on frequent, private, self-reported data. Capture puts phone diaries, eConsent and a site-side eCRF in one study with one audit trail.
- Daily phone diaries by link
- Coded IDs for analysts
- Free sandbox
Free sandbox · No credit card · 21 CFR Part 11 compliant
| Assessment | Screen | Cycle 1 | Cycle 2 | Cycle 3 | Follow-up |
|---|---|---|---|---|---|
| eConsent | |||||
| Daily symptom diary | D | D | D | ||
| Clinic assessment (eCRF) | |||||
| Wearable sync (if enabled) | D | D | D | ||
| Adverse events |
D = daily entry on the participant's phone, x = done at the visit
What women's health studies ask of a data system
- Most of the evidence is self-reported and frequent: bleeding, pain, mood, sleep, symptoms, test results at home. The tool must make a daily entry take seconds on a phone.
- The data is intimate. Cycle, fertility, pregnancy and menopause records are health data under the GDPR and, in the US, protected health information when a covered entity is involved. Access by role matters more than usual.
- The studies are often small and sponsored by young companies with no IT department. A tool they can build, test and launch themselves is the difference between starting this quarter and next year.
- Participants can change status during a study: a pregnancy, a diagnosis, a decision to stop. Consent, withdrawal and safety reporting need a clear, dated record.
- This page covers the programme level. Single-condition pages are linked below for IVF, endometriosis and PCOS, and menstrual cycle tracking.
The shape of the work
Why women's health studies strain generic survey tools
Teams in this area often start with a survey tool and a spreadsheet. It works for a pilot and fails at the first regulatory question: who changed this value, when, and why? A cycle-length value corrected by hand with no reason recorded is a data integrity problem, not a typo. An EDC records the old value, the new value, the user and the reason on every change, and the record cannot be edited through the interface. See audit trail software for clinical trials.
Frequency is the second strain. A study with daily entries for three cycles produces dozens of tasks per participant. Capture sends questionnaires to the participant's phone by link, with no app to install, and uses a reminder ladder so a missed entry gets a prompt without a coordinator phoning anyone. Question types cover scales, sliders, yes/no, single and multiple choice, dates, times and free text, which is enough for bleeding scores, pain scales and symptom checklists.
Private by role, not by promise
Site coordinators see names for their own site and researchers see coded participant IDs. Row-level security enforces the split at the database. Data is encrypted with AES-256 at rest and TLS in transit, and you choose EU (Frankfurt) or US (N. Virginia) hosting when you set up the study. Capture is GDPR compliant and HIPAA compliant, with a data processing agreement and a business associate agreement on request.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Programme map
Women's health study types and what each needs in Capture
| Study area | Typical data | Cadence | How Capture covers it |
|---|---|---|---|
| Cycle and fertility tracking | Cycle day, bleeding, ovulation test results, temperature | Daily | Phone diary with cycle-day logic; optional wearable sync. See menstrual cycle tracking study software. |
| Fertility treatment | Stimulation response, procedures, outcomes | Per visit | eCRF for clinic data. See EDC for IVF and fertility trials. |
| Endometriosis and PCOS | Pain, symptom burden, hormone panels | Weekly or daily plus visits | ePRO plus lab table forms. See EDC for endometriosis, PCOS and fertility trials. |
| Pregnancy and postpartum | Visit measures, mood, sleep, infant feeding | Visits plus short check-ins | eCRF plus phone check-ins. See EDC for postpartum depression trials. |
| Menopause and midlife | Vasomotor symptoms, sleep, quality of life | Daily or weekly | Sleep and symptom diaries with scales and sliders. |
| Contraception and device studies | Use, adverse events, satisfaction | Monthly | Adverse event forms with seriousness fields; export for analysis. |
Study areas are examples, not a claim that Capture holds any validated instrument. Check licensing for any questionnaire you use.
Build a practice study with fake participants
Draft the diary, consent and clinic forms in the free sandbox and run a week of entries before you submit to ethics.
Self-reported data
Diaries that participants actually finish
Compliance drives the value of a diary study. Each participant gets a link that opens the day's questionnaire in their phone browser. Reminders escalate on a schedule you set, so missed entries get a prompt without staff chasing everyone.
- Link-based entry with no app install.
- Reminder ladder instead of manual chasing.
- Entries are time-stamped, so late entries are visible rather than hidden.
When due
18:00
Your evening diary is open
Next day
18:00
Reminder: your diary is still open
Final notice
21:30
Last chance before the window closes
Quiet hours
22:00 to 08:00 in the participant's time zone
Stops
As soon as the task is completed
Consent and change of status
Consent that records what the participant agreed to, and when
Capture eConsent takes the participant's on-screen signature with an emailed one-time code. The investigator countersigns with password re-entry, and each signature is hashed to the exact document. When circumstances change, for example a participant becomes pregnant in a study that needs to know, the record shows what she consented to at the time and the audit trail shows what changed afterwards.
- Signed PDF with timestamps for the trial master file.
- Witness and legally authorised representative signatures where needed.
- A consent template library to start from.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Launch plan
From protocol to first participant
- 1
Upload the protocol
The AI study builder drafts visits and forms. Your team reviews each before anything is saved.
- 2
Add the diaries
Build or adapt a daily symptom diary. Set the schedule and the reminder ladder.
- 3
Test with fake participants
Run entries, edit checks, consent and an adverse event end to end in the sandbox.
- 4
Submit to ethics
Export the blank eCRF PDF and attach the consent text.
- 5
Go live
Approve the forms, which locks them for live use, then invite participants by link or QR code.
Readiness
Before you enrol the first participant
Data list
One page naming every variable, who enters it and how often.
Privacy documents
Data processing agreement, hosting region and a role matrix. See GDPR compliant clinical trial software.
Instrument licences
Check the rights holder's terms for any named questionnaire. Capture records licence details on patient questionnaires but does not verify them.
Safety plan
Who reviews adverse events and how a pregnancy or other reportable event is escalated.
Wearable plan
If a device is used, confirm with us which devices are enabled before you commit to one.
Can Capture run a women's health study with daily diaries?
Yes. Participants receive a link that opens the day's questionnaire on their phone, with reminders on a schedule you set.
Is cycle, pregnancy and fertility data protected?
It is health data, and Capture applies role-based access, PII segregation, AES-256 encryption at rest and TLS in transit. Capture is GDPR compliant and HIPAA compliant, with EU and US data hosting.
Can I sync a wearable?
Capture connects wearables by native OAuth sync where the study team has enabled a device. Which devices are available changes, so ask us before you plan around one.
Do you supply validated questionnaires?
No. Capture does not supply licensed instruments or their wording and does not verify licences. You add your instrument, and for patient questionnaires you can record licence details.
Is this only for fertility companies?
No. It suits any sponsor in women's health research, including academic groups, femtech companies and clinical teams. Single-condition pages are linked for IVF, endometriosis and PCOS, and cycle tracking.
Is there a participant-language option?
This page does not claim multilingual questionnaires. Contact us about current language support before you plan screens in other languages.
What does it cost to try?
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants.
Keep exploring
Related pages
Menstrual cycle tracking study software
Cycle-day logic and ovulation tests.
EDC for IVF and fertility trials
Clinic-side fertility data.
EDC for endometriosis, PCOS and fertility trials
Symptom-led conditions.
EDC for postpartum depression trials
Postpartum mood studies.
Patient diary software for clinical trials
Daily entries by link.
eConsent software for clinical trials
Signatures and countersignature.
Pricing
Free sandbox.
Start your women's health study in the free sandbox
Build the diary, consent and clinic forms and test them with practice participants before any fee.