Choose the best clinical strategy with the help of our seasoned clinical drug development experts.…
Decentralised studies
Our three-fold expertise in the regulatory, digital, and logistics fields makes ICTA a partner of choice to conduct decentralised or hybrid studies.
We will advise you on the best set of solutions to choose to make your project feasible and optimize it.
– 2000 –
ALWAYS A STEP AHEAD AND WELL BEFORE DECENTRALISED STUDIES…
ICTA MOVES INTO THE DIGITAL AGE
For over 20 years, ICTA has been developing web-based digital tools dedicated to
THE MANAGEMENT OF CLINICAL STUDIES
i-TMS, eREPORT, i-COM, IWRS/RTSM
Tools validated according to 21 CFR Part 11, GAMP 5, and ISO 27001 and 9001 standards
THE SECURE COLLECTION OF CLINICAL DATA
eCRF fully integrated in Data Management activities, ePRO, eDiary, eCOA… hosted in our servers in France
Collected data anonymized or pseudonymised in accordance with CNIL and GDPR requirements
– 2016 –
DEVELOPMENT OF NEW DIGITAL SOLUTIONS
As 2016 onwards, new digital solutions dealing with personal data appear in the e-health sphere:
Connected objects
Electronic consents
Video consultations
Electronic and share medical records
– 2018 –
The implementation of GDPR regulates the processing of personal data.
– 2020 –
COVID19 PANDEMIC BOOSTS THE DIGITALISATION OF CLINICAL TRIALS
With the COVID-19 pandemic, the need for continued patient care has encouraged the use of these digital solutions, and, as a consequence, their use in clinical studies:
- Patient recruitment
- Information on the study and signature of informed consents
- Follow-up visits as scheduled in the protocol
- Dispensing of study treatments
- Remote monitoring of clinical data
– AT THE SAME TIME –
At the same time, since 2020, the ANSM and the EMA have been adopting new positions and have been publishing guidelines for the implementation of decentralised studies and the use, under certain conditions, of these digital tools. These guides, which are regularly updated, define a regulatory framework that we integrate in our developments.
– 2021 –
ICTA, PARTNER OF CHOICE
FOR YOUR DECENTRALISED STUDIES
Developing digital solutions requires the support of a wide range of expertise. This is why ICTA’s IT department has entered into strategic partnerships and offers a complete range of secure, configurable and easy-to-use solutions, enabling the full or partial decentralisation of your clinical studies in compliance with the regulations in force.
Electronic consents
Teleconsultation
Telemonitoring
(secure file sharing)
These applications process directly identifiable sensitive data, and guarantee the secure management of your clinical studies (validated tools, GDPR compliance, data stored in health data hosting companies). Tested during the pandemic period, they facilitate close monitoring of investigational sites and patients, real-time control of data and their rapid analysis.
These effective technical tools are of course only fully effective if backed up by responsive, experienced and supportive operational teams. The new digital solutions are tools that facilitate clinical research and the follow-up of patients in their healthcare journey. They offer real opportunities in cases where the feasibility of traditional approaches is limited.
DIGITAL SOLUTIONS
PROJECT
MANAGEMENT
i-TMS
eREPORT
SECURE
COMMUNICATION
i-COM
RANDOMISATION /
TRIAL SUPPLY MANAGEMENT
IWRS / RTSM
DECENTRALISED CLINICAL TRIALS WILL INCREASE
ICTA is at the forefront of technology by offering a range of secure solutions, ensuring data protection and consistency.
DATA COLLECTION
e-CRF / e-PRO
Connected tools
DIGITAL
SOLUTIONS
Patient enrollment
Patient information
Electronic consent
Teleconsultation
Telemonitoring
Built on decades of operational experience and extensive therapeutic experience, ICTA can assist you in navigating the assessment, the planning and execution of decentralised and hybrid clinical trials.
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Decentralised studies
Our three-fold expertise in the regulatory, digital, and logistics fields makes ICTA a partner of…
