About Ofni Clinical
Ofni Clinical is a clinical data management tool from Ofni Systems that rapidly creates and implements secure, regulatory compliant clinical trial databases. It combines project management, document generation, and gathering requirements so clinical researchers can effectively manage their trial data. Designed for efficiency, Ofni Clinical supports the entire data lifecycle, ensuring compliance with industry standards. With features like FastVal Details and a dedicated support line, it provides users with necessary resources for successful clinical trial management. Key capabilities: project management document generation gathering requirements FastVal Details secure database implementation Best for: clinical researchers and organizations that need reliable data management solutions for clinical trials.
Ofni Clinical, developed by Ofni Systems, is a specialized clinical data management tool designed to facilitate the creation and implementation of 21 CFR Part 11 compliant clinical trial databases. The software aims to provide a secure, efficient, and cost-effective solution for clinical trial data management, making it particularly useful for organizations that need a reliable system to capture, validate, and manage clinical data. By supporting both electronic and paper-based data collection, Ofni Clinical allows researchers to transition smoothly from traditional paper Case Report Forms (CRFs) to a digital environment, thereby streamlining data handling and reducing administrative burdens. The software is built with a strong emphasis on regulatory compliance, ensuring adherence to critical industry standards such as 21 CFR Part 11, Annex 11, and HIPAA, which makes it suitable for organizations dealing with highly sensitive patient data. One of the standout aspects of Ofni Clinical is its rapid implementation capability. Unlike many clinical trial management systems that require extensive setup and customization, Ofni Clinical can be implemented within a short timeframe—often less than a month.
Pros & Cons
- +Ensures compliance with 21 CFR 11, Annex 11, and HIPAA regulations.
- +Rapid implementation, often within a month.
- +Supports both paper-based and electronic data capture (EDC).
- +Automates query resolution and facilitates data cleaning.
- +Customizable to match existing Case Report Forms (CRFs).
- −Limited public information on integration with other clinical trial management systems.
- −Primarily focused on regulatory compliance, with fewer advanced analytics features.
- −No mention of cloud-based or SaaS deployment options.
- −May require initial training for full utilization.
Features
Key features
- Rapid Database Creation and Implementation
- Enables quick development and deployment of clinical trial databases.
- 21 CFR Part 11 Compliance
- Ensures adherence to regulatory requirements for electronic records and signatures.
- Electronic Case Report Forms (eCRFs)
- Supports electronic data capture, reducing reliance on paper CRFs.
- Automated Data Queries
- Automates the creation, review, and resolution of data queries.
- Data Validation and Edit Checks
- Includes extensive features to identify and correct data entry errors.
- Flexible Customization
- Allows for tailoring the system to specific trial needs.
Additional features
- Clinical Data Management Tool
- Designed for managing clinical trial data.
- Secure Database Creation
- Creates secure and compliant clinical trial databases.
- Regulatory Compliance (21 CFR 11, Annex 11, HIPAA)
- Adheres to industry regulations for data security and management.
- Comprehensive Search and Report Features
- Includes tools for searching and reporting on trial data.
- Strong Data Validation and Edit Check Options
- Offers various options for data validation and error detection.
- Flexible Customization Tools
- Allows for adapting the system to specific study requirements.
- Cost-Effective Implementation
- Designed for quick and economical implementation.
- Paper and Paperless Data Capture
- Supports data capture from paper CRFs or as a fully electronic system.
- Case Report Form (CRF) Matching
- Aligns with existing CRFs to minimize training costs.
- Double-Data Entry Support
- Facilitates double data entry for improved data quality.
- Data Cleaning and Remediation Tools
- Provides tools for cleaning and correcting data.
- Intuitive User Interface
- Designed for ease of learning and administration.
- No Special Software or Annual License Fees
- The sponsor owns the system and the data.
- Electronic Case Report Forms (eCRFs)
- Enables electronic data capture.
- Edit Checks
- Includes features for data validation and error detection.
- MedWatch Form 3500A Support
- Supports the generation of MedWatch forms.
- Service and Support
- Offers customer support and assistance.
- Frequently Asked Questions (FAQ)
- Provides answers to common questions.
- Benefits Information
- Highlights the advantages of using Ofni Clinical.
Pricing
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Available in
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About Ofni Clinical
Ofni Clinical is a clinical data management tool from Ofni Systems that rapidly creates and implements secure, regulatory compliant clinical trial databases. It combines project management, document generation, and gathering requirements so clinical researchers can effectively manage their trial data. Designed for efficiency, Ofni Clinical supports the entire data lifecycle, ensuring compliance with industry standards. With features like FastVal Details and a dedicated support line, it provides users with necessary resources for successful clinical trial management. Key capabilities: project management document generation gathering requirements FastVal Details secure database implementation Best for: clinical researchers and organizations that need reliable data management solutions for clinical trials.
Ofni Clinical Details
Ofni Clinical's In-App Market Place
Does Ofni Clinical 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$), Jpy (¥), Chf (Fr), Cny (¥), Inr (₹), Rub (₽), Brl (R$), Hkd (Hk$), Sgd (S$), Krw (₩), Try (₺), Zar (R), Mxn ($)
Pros & Cons
- Ensures compliance with 21 CFR 11, Annex 11, and HIPAA regulations.
- Rapid implementation, often within a month.
- Supports both paper-based and electronic data capture (EDC).
- Automates query resolution and facilitates data cleaning.
- Customizable to match existing Case Report Forms (CRFs).
- Limited public information on integration with other clinical trial management systems.
- Primarily focused on regulatory compliance, with fewer advanced analytics features.
- No mention of cloud-based or SaaS deployment options.
- May require initial training for full utilization.
Ofni Clinical's Support Options
Contact
(919) 844-2494Ofni Clinical's Alternatives
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