Baseline Plus
Cisiv's Baseline Plus is a highly flexible, fully intergrated platform with a complete set of tools and workflows configured to meet the highly diverse challenges of real world late phase research.
What is Baseline Plus?
What makes Baseline Plus unique?
How can Baseline Plus address your post-marketing needs?
Why should you trust Cisiv?
Frequently asked questions
Is the system validated according to GAMP?
Cisiv’s policies and procedures have been defined according to industry’s regulatory standards
Quality Management System
• GAMP
• GCP
• ISO 9001:2015
21 CFR Part 11 compliant
• E-signatures
• Audit trail
• Access management
• CSV / GAMP
Data Privacy & Security
• GDPR
• HIPAA
• ISO 27001
Audited annually:
• ISO
• UK patient information governance
• Sponsor/partner audits
What are the license costs? Is it possible to purchase packages of licenses valid for a specific period?
Yes, you can have a license per period. License costs for the study conduct are monthly. They are proportional to the number of patients in the study and number of modules.
License costs are generally per study.
We can also license out the designer tool if you want to build studies in-house. There is a fixed cost per year regardless of the number of studies you build.
Does the system allow to set different roles within the eCRF? Are they customisable? If yes, what privileges can be set?
Yes. We have a configurable set of roles and permissions that can be applied per study. There is a hard separation between site roles (enter data about a patient), patient / carer roles (enter your own data) and admin roles (all study management). Within this separation we can configure as many roles as necessary and assign permissions to them. Typically, we defined one or more standard templates with a customer that are applied to all studies.
Is it possible to set strong authentication in the system?
Yes. We support 2 Factor authentication.
Is there a randomisation tool?
Yes, we have a randomisation which is based on randomising a known number of patients. It can be applied to randomise within a site, country or study as a whole.
Is it possible to perform Source Data Verification?
Yes. The source data verification is managed by a monitor role. Baseline Plus has an SDV module designed around the way SDV is commonly carried out (if at all) in Late Phase.
Is it possible to localise your platform to other languages?
Yes. Cisiv is able to localise all modules, including the EDC, ePRO, eConsent.
Is it possible to set PV alert to send to certain roles? Does the system produce follow-up alerts in case of data edit?
As standard we configure a PV alert when an AE is submitted or updated. We configure the target emails for the alerts and whether all AEs send an alert of only serious.
We can also configure more sensitive triggers based on the data in the AE.
Follow up alerts/notifications can be set up to go to sites if AEs are still open or if they are pending signature (if AE signature is required).
