The verdict in three sentences
A CRO tracking 25 studies and 140 investigator sites on spreadsheets faces a real inspection risk: no audit trail, multiple file versions, poorly pseudonymised patient data. An off-the-shelf CTMS costs EUR 40,000 to 120,000 per year in licences, whereas a custom app sized to your processes often pays back within 2 to 3 years. The project holds up if it builds in GCP traceability, electronic signatures, pseudonymisation and certified health data hosting from day one.
Why spreadsheets no longer pass an inspection
Good Clinical Practice (ICH E6 R3, applicable since 2025) requires computerised systems used to run a trial to be reliable, validated and traceable. In Europe, EU GMP Annex 11 principles and GDPR apply; for US sponsors, 21 CFR Part 11 is expected. A shared spreadsheet cannot show who changed a monitoring visit date or why. During a sponsor audit or a regulator inspection, reconstructing history becomes days of manual work.
| Regulatory requirement | On spreadsheets | What the app must provide |
|---|---|---|
| Audit trail (who, what, when, why) | missing or partial | immutable time-stamped log of every change |
| Electronic signature of approvals | print and sign by hand | identity-bound signature with reason and timestamp |
| Patient pseudonymisation | initials and date of birth in files | unique patient code, key table kept at the site |
| Health data hosting | file server or non-certified cloud | certified health data host (HDS in France, ISO 27001 at minimum elsewhere) |
| Access control | file shared with everyone | roles by study, site and function |
| Archiving | scattered folders | 25-year retention of essential documents, structured export |
For a 70-person CRO, a major inspection finding can cost an entire sponsor contract, worth several hundred thousand euros in revenue.
The functional scope of a CTMS built for a CRO
- Study portfolio: protocols, amendments, milestones, budget per study and sponsor.
- Investigator sites: 140 sites with contacts, contracts, selection and activation status, hospital agreements.
- Patient recruitment: screening, enrolment, withdrawals by pseudonymised patient code, with planned versus actual recruitment curves.
- Monitoring visits: scheduling, visit reports, corrective action tracking, automatic reminders to CRAs.
- Site payments: investigator fees calculated from completed visits, accounting exports.
- Sponsor dashboards: progress, protocol deviations, query resolution times.
Integration with the EDC and the eTMF runs through APIs or scheduled exports. System validation (validation file, documented tests) is part of the project and must be budgeted explicitly.
Off-the-shelf CTMS or custom app
| Criterion (2026 estimate) | Vendor CTMS | Kolonell custom app |
|---|---|---|
| Annual licence | EUR 40,000 to 120,000 depending on users and modules | no licence |
| Setup and configuration | EUR 30,000 to 80,000 | included in the build |
| Build | not applicable | complex: 7,000,000 to 15,000,000+ FCFA (EUR 10,670 to 22,870+), a full CTMS often lands above that, priced in the quote |
| Maintenance | included in licence | 35,000 to 120,000 FCFA per month (EUR 53 to 183) |
| Certified hosting | often included | in the quote depending on volume and host |
| Process fit | you adapt to the tool | the tool follows your SOPs |
| Timeline | 3 to 6 months | 5 to 8 months |
A vendor CTMS brings maturity and ready-made validation packs. A custom build wins when your SOPs are specific, when sponsors demand particular reports, or when the annual licence exceeds EUR 60,000. Validation files, EDC integration and certified hosting are priced in the quote.
A 5 to 8 month plan
| Phase | Duration | Deliverable |
|---|---|---|
| SOP and data flow mapping | 4 weeks | functional specs, risk assessment |
| Studies, sites, access and audit trail | 8 weeks | validatable core |
| Recruitment, visits, e-signatures | 6 to 8 weeks | CRA operational module |
| Site payments and dashboards | 4 weeks | accounting exports, sponsor reports |
| Validation and data migration | 4 to 6 weeks | validation file, 25 studies migrated |
Mini case study
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Antoine, head of operations at a 70-person CRO, compares two options over 5 years.
- Vendor CTMS: EUR 70,000 per year in licences for 45 users, plus EUR 50,000 of setup. Over 5 years: 70,000 × 5 + 50,000 = EUR 400,000.
- Custom build: assume a complex build quoted at EUR 120,000 including validation, EDC integration and certified hosting, plus Premium maintenance at EUR 183 per month (EUR 10,980 over 5 years) and an enhancement budget of EUR 20,000 per year. Over 5 years: 120,000 + 10,980 + 100,000 = about EUR 231,000.
Even with a cautious build assumption, the gap exceeds EUR 160,000. Antoine also saves about 6 hours per week per project manager on reporting: 8 project managers × 6 h × 46 weeks = 2,208 h per year.
FAQ
Can a custom app be validated under GCP?
Yes. Validation rests on specifications, a risk assessment and documented tests, whoever the vendor is. Allow 15 to 20% of project effort for the validation file.
Is certified health data hosting mandatory?
In France, as soon as the app stores personal health data on behalf of a third party, yes (HDS). Elsewhere in Europe, GDPR and sponsor requirements usually impose ISO 27001 hosting at minimum.
Does the electronic signature need to be qualified?
For internal CTMS approvals, a simple electronic signature with strong authentication, reason and timestamp is generally enough. Regulatory documents may require an advanced level, at EUR 1 to 3 per signature through a provider.
How long does migrating 25 existing studies take?
Between 4 and 6 weeks depending on how inconsistent the spreadsheets are. An ongoing study takes on average 1 to 2 days of cleaning and controlled import.
Can the app connect to our EDC?
If the EDC has an API or scheduled exports, yes, in 8 to 15 development days. Visit statuses and queries then flow automatically into dashboards.
Let's scope your project. Share your main SOPs and number of active studies, and we will scope a validatable build with a 5 to 8 month plan. 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.
