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 has been created, 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.
