EDC platform review
Sealed Envelope Red Pill review
Red Pill is Sealed Envelope's online database for electronic data capture and ePRO, with randomisation built in from the company's randomisation service. It is mainly used by university clinical trials units and research groups running randomised trials.
- Our score
- 5.8/10
- Best for
- UK academic randomised trials needing UK-hosted data
- Pricing
- Per-study quote for Red Pill; randomisation services priced separately
- Vendor
- Sealed Envelope Ltd, London, UK
Unique feature
Built-in randomisation from a long-standing service
Randomisation is an integral part of Red Pill, drawing on Sealed Envelope's online randomisation service ("Internet randomisation since 2001"), which is also sold separately with published prices.
Fit
Who Sealed Envelope Red Pill suits
Best for
- Academic randomised controlled trials needing randomisation and CRF data in one system
- UK-based trials wanting UK-hosted data
- Trials collecting participant questionnaires via email or SMS links
Less suited to
- Studies requiring CDISC-format exports (not stated by vendor)
- Field work needing offline data collection on a mobile app (not described)
- Multinational studies needing translated forms (language support not stated)
Features
Key features
What the vendor documents publicly, checked against its own pages. “Not stated” means we could not confirm it, not that it is missing.
✓ Yes◐ Partly+ Add-on– No? Not stated
- ◐Vendor builds your databaseCustomer builds CRF; Sealed Envelope applies requested customisations
- ✓Build forms yourselfDrag-and-drop CRF Builder with test environment
- ✓Audit trailAudit trail logs data changes, randomisations, unblinding and downloads
- ◐Electronic signaturesPassword-confirmed declarations; e-signature feature not named
- ✓Edit checks at data entryValidation rules during entry; overrides need a justification
- ✓Queries and source data verificationQueries; forms can be marked validated after monitoring
- ✓RandomisationIntegral; web or telephone randomisation, code break
- ✓ePRO and participant self-entrySubject-entered forms via unique email/SMS links
- ?eConsent
- ?Offline mobile data collectionResponsive browser design for phones and tablets; no offline app described
- ?Forms in several languages
- ?CDISC export (ODM / SDTM)Exports CSV and Stata fixed format
- ✓Built-in reports and dashboardsStandard data-entry, query, visit and randomisation reports
- ?Built-in statistical analysis
- ?Numbered tables, figures and listings
- ◐APIUser guide lists a randomisation API; data API not stated
- ?Free or open-source optionRed Pill quoted; free tiers only for simple randomisation
Verdict
Strengths and limitations
Strengths
- Randomisation built in, with code break and SMS options
- UK hosting and ISO 27001:2022 certificate
- Published prices for the standalone randomisation services
Limitations
- No published pricing for Red Pill
- CDISC export, eConsent and multilingual forms not stated
- Data exports limited to CSV and Stata formats in documentation
Details
Pricing, hosting and regulation
Pricing
Per-study quote for Red Pill; randomisation services priced separately. Published prices: Red Pill: not published. Randomisation (ex VAT): Simple - free set-up and first 50, then £95 per 50; Simple + - £95 set-up incl. first 50, then £95 per 50; full service from £2,270 set-up (academic/non-profit, unblinded) and from £80/month (up to 100 randomisations).. Pricing source.
Hosting and security
Hosting regions: UK (Rackspace and AWS London), replicated to AWS Ireland for disaster recovery. Vendor-hosted; no self-hosting option stated.
Certifications: ISO 27001:2022 (vendor; Alcumus ISOQAR certificate, expires May 2027), Cyber Essentials (vendor), NHS Data Security and Protection Toolkit: Standards Met (vendor).
Regulatory support
Vendor cites ISO/IEC 27001, Cyber Essentials, NHS DSPT and UK/EU GDPR; 21 CFR Part 11 not stated.. Whatever the software offers, your own procedures, validation and training are still needed for a regulated study.
Scale and set-up
Vendor states its systems "have randomised thousands of patients in hundreds of trials"; client logos are mainly universities and research units.. Self-service CRF build in the CRF Builder, with a test environment available at any time; Sealed Envelope adds requested customisations after the CRF is built. Go-live time not stated..
Alternatives
Alternatives to Sealed Envelope Red Pill
Castor EDC
Self-built academic and MedTech studies, with UK, EU, US or Australian hosting.
Score 7.5/10 · Unique feature: Choice of EU, UK, US or Australian hosting
ResearchGuru EDC
Teams that want the database built for them, with TFLs and analysis included.
Score 8.6/10 · Unique feature: EDC, automated TFLs and automated analysis in one platform
OpenClinica
Small to mid studies wanting published prices or open-source software.
Score 7.7/10 · Unique feature: Open-source Community Edition
- Sealed Envelope: Red Pill
- Sealed Envelope home page
- Sealed Envelope pricing
- Sealed Envelope security and data protection
- Sealed Envelope ISO 27001 certificate (PDF)
- Red Pill and Randomisation help
- Red Pill user guide v25 (PDF)
- Red Pill: Subject entered forms (ePRO)
- Getting started with the CRF builder
- Red Pill customisations
- Newcastle University CONFORM-OH: Red Pill User Guide
- Sealed Envelope Red Pill help