The verdict in three sentences
Tracking 45 investigator sites in shared spreadsheets exposes a CRO to wrong investigator payments, missed monitoring visits and GDPR risk on health data. Market CTMS platforms cost EUR 40,000 to 120,000 a year and impose their own workflow, while a custom app hosted in the EU mirrors the CRO's real processes. Since the EU Clinical Trials Regulation 536/2014 became fully mandatory in January 2025, sponsors expect cleaner site-level data for CTIS submissions, which tilts the case toward a proper system.
What spreadsheets cost a 60-person CRO
The operations director of a Dublin CRO runs 12 active studies across 45 sites in Ireland, the UK and the EU. Each project manager keeps their own file, and month-end consolidation takes days.
| Activity | With spreadsheets | With a dedicated app |
|---|---|---|
| Monthly enrolment roll-up per site | 3 days per project manager | live dashboard |
| Monitoring visit planning | manual reminders, 5 to 10 % of visits slip | automatic alerts per visit window |
| Investigator fee calculation | 2 days a month, 3 to 5 % discrepancies | calculated per procedure and per patient |
| Deviations and CAPA tracking | separate files | single register with audit trail |
| Sponsor audit preparation | 5 to 8 days | export in a few hours |
| Change traceability | almost none | time-stamped log per user |
Across 8 project managers, consolidation alone takes 24 days a month, more than one FTE.
Market CTMS or custom app
Figures below are 2026 estimates for a CRO of 50 to 80 people.
| Criterion | Global CTMS vendor | SME-focused CTMS vendor | Custom app |
|---|---|---|---|
| Annual licence or subscription | EUR 80,000 to 120,000 | EUR 40,000 to 70,000 | none, hosting and maintenance only |
| Implementation | EUR 30,000 to 80,000 | EUR 10,000 to 30,000 | included in the project |
| Rollout time | 6 to 12 months | 3 to 6 months | 16 to 20 weeks |
| Fit with CRO processes | low, configuration only | medium | full |
| EU data residency | often optional | varies | built in from day one |
| Computerised system validation (GAMP 5) | vendor pack supplied | partial | to be produced, quoted separately |
| Ownership of data and code | vendor | vendor | CRO |
Patient data is pseudonymised (study subject number) and the app should never store identities without a legal basis. In Ireland, the Data Protection Commission and the Health Research Regulations 2018 add consent and safeguard requirements on top of GDPR.
One practical point for Irish CROs: since the EU Clinical Trials Regulation routes submissions through CTIS, sponsors increasingly ask for site-level status, enrolment and deviation data in a consistent format. A custom app can export these fields in the exact structure your sponsors use, which typically saves 1 to 2 days per study at each reporting cycle and reduces back-and-forth queries during inspections by the HPRA.
Kolonell's budget
Kolonell builds this type of app on its custom grid: simple, 2,500,000 to 4,000,000 FCFA (EUR 3,810 to 6,100), medium, 4,000,000 to 7,000,000 FCFA (EUR 6,100 to 10,670), complex, 7,000,000 to 15,000,000+ FCFA (EUR 10,670 to 22,870+). Multi-study tracking with sites, visits, enrolment, fees and audit trail sits in the complex band. EU health-grade hosting, the validation pack and eCRF connections are quoted separately. Timeline is 16 to 20 weeks, including acceptance on a pilot study. Maintenance at 35,000, 75,000 or 120,000 FCFA per month (EUR 53, 114 or 183) covers fixes and minor changes. See our web applications service.
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Siobhan, operations director of a 60-person CRO in Dublin, compares two options over 3 years. SME-focused CTMS: EUR 55,000 a year plus EUR 20,000 implementation, EUR 185,000. Custom app in the complex band, taken at around EUR 22,000, plus EU hosting estimated at EUR 6,000 a year and Premium maintenance at EUR 183 a month, about EUR 2,200 a year: 22,000 plus 3 times 8,200, EUR 46,600.
The 3-year gap is about EUR 138,000, before the validation pack and enhancements budgeted separately. Time savings come on top: 24 days of consolidation a month drop to 4, freeing 20 days, roughly one project manager FTE moved to sponsor invoicing.
FAQ
Is health-grade hosting required if patients are pseudonymised?
Pseudonymised data is still personal health data under GDPR. Hosting must offer EU residency, encryption and access logging, typically EUR 300 to 800 a month for an app this size.
Do we need GAMP 5 validation?
If the tool touches GCP-regulated data, sponsors expect a risk-based validation pack. For a management CTMS it usually runs 40 to 80 pages of specs and test scripts.
Can the app connect to our eCRF?
Yes, if the eCRF exposes an API, as most market solutions do. Syncing enrolments removes double entry for 100 % of recruited subjects.
How are investigator fees handled?
Each procedure (enrolment, visit, test) is priced from the site contract grid, and the app produces the quarterly statement. The 3 to 5 % spreadsheet discrepancies almost disappear.
How many users can it support?
The planned architecture handles 200 to 500 accounts comfortably, including restricted access for site research coordinators.
Let's scope your project. Send us your active study list and tracking spreadsheets, and we will scope an EU-hosted app deliverable in 16 to 20 weeks. Detailed quote within 48 h. WhatsApp +221 77 596 93 33.
Mohamed Bah
Fondateur, Kolonell
Passionate about digital and entrepreneurship in Africa, Mohamed has been helping Sénégalese businesses with their digital transformation since 2020. Founder of Kolonell, he believes every SME deserves a professional and accessible online présence.
