Full-service CRO for clinical trials: design, regulatory, monitoring, vigilance, data management, biostatistics and medical writing
ICTA – International Clinical Trials Assistance
Fontaine-lès-Dijon (France) · Dijon (France)New on Amplifa
About ICTA
ICTA is an international contract research organization (CRO) based in Fontaine-lès-Dijon in Burgundy, France. Founded in 1984 by Dr. Michel Hantzperg and Dr. Aline Hantzperg, the company employs more than 150 staff and supports pharmaceutical, biotech and medical device companies across the entire lifecycle of their products. The full-service portfolio covers study design and methodological consulting, regulatory affairs including submissions under EU Regulation 536/2014, centralized project management, risk-based monitoring (on-site, remote, centralized), pharmacovigilance and materiovigilance with the safety database Safety Easy®, data management in CDISC/SDTM format, biostatistics including adaptive and Bayesian methods, and medical writing. This is supported by the proprietary, scalable IT platform i-SIT® with modules for e-CRF, e-PRO, IWRS, i-TMS® and i-Report®. Through the freelance network FreeCRA and the subsidiary ICTA Iberia launched in 2026, ICTA additionally offers local study support in Spain, Portugal and other EU countries. The geographical focus lies on Europe.
- Site
- Fontaine-lès-Dijon, France
- Processes
- Clinical study design (protocols, synopses, CRFs), Regulatory affairs and submissions, Project management (full-service), Risk-based monitoring (on-site, remote, centralised), Vigilance / Pharmacovigilance / Materiovigilance, Data management (e-CRF, CDISC, SDTM, database lock), Biostatistics (frequentist, adaptive, Bayesian, data mining), Medical writing (study reports, articles, posters, abstracts)
- Materials
- Study Design, Regulatory Affairs, Risk-based Monitoring, Vigilance, Data Management, Biostatistics, Medical Writing
- Certificates
- ISO 9001:2015, ISO 9001
- Founded
- 1984
- Employees
- >150
- Industries
- Pharma (Top-20 and mid-size laboratories), Biotech, MedTech / Medical devices & diagnostics
- 01
Study Design & Methodology
- 02
Regulatory Affairs & Submissions
- 03
Feasibility & Site Selection
- 04
Project Management
- 05
Monitoring & Site Support
- 06
Vigilance / Pharmacovigilance
- 07
Data Management
- 08
Biostatistics
- 09
Medical Writing & Reporting
Services and Methods
Study Design
Development of protocols, synopses and CRFs for interventional and non-interventional studies, including adaptive and Bayesian approaches.
Regulatory Affairs
Regulatory strategies and submissions in accordance with national and European regulations, including EU 536/2014.
Risk-based Monitoring
On-site, remote and centralized monitoring based on risk-based monitoring plans with key risk indicators.
Vigilance
Pharmacovigilance and materiovigilance with the ICH-E2B-compliant database Safety Easy® and electronic reporting to EudraVigilance.
Data Management
From e-CRF development to database lock in a SAS® environment, CDISC/SDTM-compliant and in accordance with 21 CFR Part 11.
Biostatistics
Statistical planning and analysis, including data mining, machine learning and ISS/ISE for FDA submissions.
Medical Writing
Preparation of study reports, articles, posters and abstracts in line with international regulatory requirements.
Locations
Fontaine-lès-Dijon
FRHead office (Corporate Headquarters)
- Materials
- Full-service CRO services
- i-SIT® IT platform (e-CRF, e-PRO, IWRS, i-TMS®, i-Report®)
- Safety Easy® safety database
- SAS® environment for data management
- CTMS via i-SIT®
Dijon
FRHead office (original Burgundy location)
Service Areas
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Clinical study design (protocols, synopses, CRFs)Engineering | – | – | – | – | – |
| Regulatory affairs and submissionsEngineering | – | – | – | – | – |
| Project management (full-service)Engineering | – | – | – | – | – |
| Risk-based monitoring (on-site, remote, centralised)Testing | – | – | – | – | – |
| Vigilance / Pharmacovigilance / MateriovigilanceTesting | – | – | – | – | – |
| Data management (e-CRF, CDISC, SDTM, database lock)Engineering | – | – | – | – | – |
| Biostatistics (frequentist, adaptive, Bayesian, data mining)Engineering | – | – | – | – | – |
| Medical writing (study reports, articles, posters, abstracts)Engineering | – | – | – | – | – |
| Site support (CRAs / Site Study Coordinators)Assembly | – | – | – | – | – |
| Freelance CRA sourcing (Spain, Portugal, EU)Assembly | – | – | – | – | – |
| Real World Evidence / non-interventional studiesTesting | – | – | – | – | – |
| Early Access / Compassionate Use Programs (EAP/CUP)Engineering | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
ICTA is certified to ISO 9001:2015 for the management and development of national and international projects in clinical research. Project management follows ISO standards and is regularly confirmed through client audits; the processes integrate ICH guidelines, GCP/GEP, ISO 14155, GCDMP, GDPR as well as 21 CFR Part 11/EU Annex 11.
| Evidence | Fontaine-lès-Dijon |
|---|---|
| ISO 9001 |
Company History
- 1984
Founded by Dr. Michel Hantzperg (former Medical Director) and Dr. Aline Hantzperg (pharmacist) in Burgundy
- 2010
FreeCRA begins supporting sponsors in Spain and Portugal
- 2024
40th anniversary
- 2026
Launch of ICTA Iberia in cooperation with FreeCRA (full service in Spain/Portugal)