DigiDyco specializes in the development of pragmatic digital applications for the clinical research sector.
Arco Information empowers DigiDyco in delivering these document and process driven e-solutions.
Dyco Flow is a Clinical Trial Reference System.:From the very start of a study until archiving status, all data that become available are stored in Dyco Flow via automatic and self-evident flows. A passage for online review through the Ethical Committee of the hospital is incorporated.
The application allows access for both sponsor and site personnel resulting in an open and effective communication tool.
It centralizes all study data and the submission requests through a single portal.
The process of submission and approval is automated.
The goal of Dyco Flow is
- to act as the reference system for the clinical projects due to its extensive and up-to date data pool
- to centralize the document submission (flow) of new trials/amendments via e-platform
- to ensure a continuous flow of the submission and approval of documents from the start up to the end of the study
- to guarantee study follow-up and reporting in a timely manner
- to control the user access and guarantee security
- under development: module for the management of study budget with follow-up of payments
- under development: communication on the study progress (inclusions) via e-CRF connection.
Some specific features for Dyco Flow:
- simple upload of documents
- restricted access for users : limited view of folders and in time
- visual control of the uploading process
- global access to your study and documents
- contract flow control
- digital signature
- reporting tool
Is a global interactive electronic Trial Master File with integration of the external investigator files.
Dyco Vision is a validated document management application to support the document collection in clinical research. With this Trial Master File, DigiDyco wants to cooperate to the global uniformization within clinical research.
Central focus during the creation was the simple and efficient design.
Thanks to the field experience of its creators, Dyco Vision offers a built-in answer to the daily inconveniences:
“We are convinced Dyco Vision allows all users to save considerable time during the conduct of your study, from start-up till archiving.”
Dyco Capture is our electronic randomization and case report form (eCRF).
The digital data collection allows availability of the data at all times and facilitates remote and risk-based monitoring.
We offer an optional independent and electronic online randomization tool for academic paper CRF studies, allowing the sites to randomise at high level.
It can be built with optional features:
• stratified block e-randomization
• patient surveys
• visibility according to role
• patient progress overview
• edit checks across forms
• CRF sign off e-signature
• reports of data
• data export
• interfacing possible
• GDPR conform, audit tracking in place
Available in 2021
Clinical research is always associated with drug safety and pharmacovigilance.
The processing of the safety information must be performed within the restricted timelines and with the highest security standards.
To deal with this requirement, Dyco Safe is under development, a secure platform to communicate the safety information.
Dyco Safe features:
- avoiding that sensitive information is communicated by e-mail over the internet
- ensuring the confidentiality of safety data by limiting access to the dedicated persons only
- audit tracking
- e-signature according to part 11
- remote oversight for managers
- full processing of SAE and follow-up
- easy and automated transfer of these safety data into Dyco Vision (the e-Trial Master File)
- in case of archiving requirements, the data can be transferred to Dyco Archive
Dyco Safe ensures that the collection, monitoring, follow-up and reporting of the clinical safety information run properly, easily and securely.
Available in 2020
Once a clinical study is at the final stage, the documents and data need to be stored for many years.
DigiDyco developed Dyco Archive, a digital platform to store all your project data in accordance with the archiving guidelines in force. For a paper study, DigiDyco can perform the scanning of the complete paper study filing.
The storage process is secured and the documents remain available for pre-defined user access.
If necessary, digital signatures along with the requisite certificates will be used to secure documents.