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About Baseline Plus
Baseline Plus is a compliance management software from Cisiv that supports organizations in managing and assessing their regulatory obligations. It provides features such as risk assessment tools, documentation management, and reporting capabilities so users can ensure compliance and mitigate risks effectively. The software is designed to help organizations keep track of ever-changing regulations and maintain accurate records, improving overall compliance management. With Baseline Plus, users can simplify their compliance processes, reduce manual tasks, and increase accountability. Key capabilities: risk assessment tools documentation management reporting capabilities customizable workflows audit trail Best for: compliance officers that need to manage regulatory requirements systematically.
Cisiv's Baseline Plus is a comprehensive and highly specialized software platform engineered for the complex world of real-world late-phase research. Its core purpose is to enable pharmaceutical companies and clinical research organizations to efficiently capture and manage data from observational studies, patient-centric solutions, eConsent, and surveys. Unlike traditional clinical trial management systems that are often rigid, Baseline Plus is built from the ground up to address the unique challenges of real-world data, such as variable schedules and data sources. The user interface is consistently praised for being simple, clear, and intuitive, a critical design choice that reduces the burden on users, including healthcare professionals who may be less familiar with research software. This user-friendly approach not only improves data quality at the source but also helps to maintain engagement over the long duration of real-world studies. Its functionality is robust and highly configurable, featuring a powerful electronic data capture (EDC) system, an integrated safety module for adverse events, and seamless support for patient-reported outcomes.
Pros & Cons
- +Designed specifically for real-world late-phase research
- +Fully integrated platform with a complete set of tools and workflows
- +Configurable and customizable to meet diverse challenges
- +Supports large-scale studies with up to 20,000+ patients
- +Compliant with global regulatory standards
- −Pricing details not publicly available
- −No information on an in-app marketplace
- −Limited information on community support options
- −No details on product documentation or knowledge base
- −No information on chatbot or live chat support
Features
Key features
- Real-world electronic data capture
- Enables collection of observational data in real-world late-phase research.
- Patient-centric solutions
- Provides tools focused on improving patient experience and engagement.
- eConsent
- Supports electronic informed consent processes for studies.
- Surveys
- Facilitates creation and distribution of patient surveys.
- Expanded and managed access programmes
- Manages access programmes for treatments beyond clinical trials.
Additional features
- Real-world electronic data capture
- Enables collection of observational data in real-world late-phase research.
- Patient-centric solutions
- Provides tools focused on improving patient experience and engagement.
- eConsent
- Supports electronic informed consent processes for studies.
- Surveys
- Facilitates creation and distribution of patient surveys.
- Expanded and managed access programmes
- Manages access programmes for treatments beyond clinical trials.
- Randomisation tool
- Allows random assignment of patients to study groups.
- Source Data Verification (SDV) module
- Ensures accuracy and integrity of collected data.
- Role-based access control
- Assigns user permissions based on roles for security.
- 2-factor authentication
- Adds an extra layer of security for user login.
- Audit trail and access management
- Tracks user actions and manages data access.
- Compliance with GAMP, GCP, ISO 9001
- 2015, 21 CFR Part 11: Ensures adherence to industry regulatory standards.
- Data privacy and security compliance with GDPR, HIPAA, ISO 27001
- Protects patient data according to international regulations.
- Multilingual support
- Supports multiple languages for global usability.
Pricing
Countries & Languages
Interface languages
Billing currencies
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About Baseline Plus
Baseline Plus is a compliance management software from Cisiv that supports organizations in managing and assessing their regulatory obligations. It provides features such as risk assessment tools, documentation management, and reporting capabilities so users can ensure compliance and mitigate risks effectively. The software is designed to help organizations keep track of ever-changing regulations and maintain accurate records, improving overall compliance management. With Baseline Plus, users can simplify their compliance processes, reduce manual tasks, and increase accountability. Key capabilities: risk assessment tools documentation management reporting capabilities customizable workflows audit trail Best for: compliance officers that need to manage regulatory requirements systematically.
Baseline Plus Details
Baseline Plus's In-App Market Place
Does Baseline Plus have an in-app market place?
Yes
How many Mini-Apps in the marketplace?
1
Mini Apps
N/A
Pricing Options
Accepted Payment Currencies
USD ($), EUR (€), GBP (£), AUD (A$), CAD (C$), JPY (¥), CHF (Fr)
Pros & Cons
- Designed specifically for real-world late-phase research
- Fully integrated platform with a complete set of tools and workflows
- Configurable and customizable to meet diverse challenges
- Supports large-scale studies with up to 20,000+ patients
- Compliant with global regulatory standards
- Pricing details not publicly available
- No information on an in-app marketplace
- Limited information on community support options
- No details on product documentation or knowledge base
- No information on chatbot or live chat support
Baseline Plus's Support Options
Email Address
info@cisiv.comContact
+44 (0)20 8939 8470Baseline Plus's Alternatives
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