In clinical research, managing complex data efficiently and accurately is crucial. Oracle InForm, a market-leading electronic data capture (EDC) system, is a robust solution used to support the development of groundbreaking medical advancements. With ClinDatrix, a company deeply invested in technology and quality assurance, Oracle InForm becomes a powerful tool for conducting your clinical trials with precision and compliance.
Ready to elevate your clinical trials with Oracle InForm and ClinDatrix’s expertise? Contact us today via phone or our online form, and let’s discuss how we can streamline your data management and enhance your study outcomes. Your journey to more efficient and compliant trials starts here.
What is Oracle InForm?
Oracle InForm stands as a premier electronic data capture (EDC) system, having played a pivotal role in the development of groundbreaking drugs. It has been instrumental in the approval of:
- 6 of the 8 FDA Fast Tracked Drugs
- 7 of the 8 First-In-Class Drugs
- 15 of the 22 Novel Drugs
(Source: 2016 FDA Approved Drugs)
Key Features of Oracle Inform
Versatile Study Design
Oracle InForm accommodates studies with multiple treatment arms and cohorts, each with varied assessment schedules. It allows for the definition of potential patient pathways through complex studies and displays only the relevant electronic case report form (eCRF) pages based on reported patient data.
Efficient Data Management
The system features embedded workflows that enable efficient management of discrepancies by Data Managers. Discrepancy data management capabilities systematically route information to specific study personnel.
Advanced Edit Checks
Oracle InForm supports sophisticated edit checks across all eCRF pages, catering to very complex studies. It also allows for defining the need for source data verification at the case report form (CRF) level to support risk-based monitoring.
Flexible Protocol Amendments
Mid-study protocol changes can be implemented without data migration, simplifying the process of rolling out amendments. Complete control over protocol amendments is provided, with the ability to stagger and schedule the rollout in accordance with local regulatory timelines. Study version assignments can be specified per site, allowing sites to upgrade to new study versions on their own schedule. In-place revisions can apply changes to all existing and new subjects.
Enhanced Reporting Capabilities
Oracle InForm offers outstanding reporting capabilities, including standard reports such as Audit Trail Reports, CRF Aging by Site, CRF Cycle Time Detail by Site, CRF Site Performance Summary by Site, CRF Status Detail by Site and Subject, CRF Status Detail by Visit and Site, CRF Status Summary by Site, and CRF Status Summary by User, among others. User-defined reports are quickly configurable, with over 150 operational reports available for self-service. Preprogrammed operational and clinical data models are provided for building ad hoc reports, graphs, and charts without requiring technical experience.
Data Viewer for Actionable Insight
The InForm Data Viewer enables users to assess and lock a site, multiple sites, or an entire trial within minutes. It includes a data comparison tool that reduces manual checks, with comparison views for adverse events (AE) and concomitant medications (Con Med) simplifying reconciliation. Users can review trends across clinical or operational data, view comments for clinical data, and export to Excel, reducing the need for programming support and allowing for ad-hoc reporting on both operational and clinical data without delays or change orders.
Global Library and Templates
Page elements can be saved in a Global Library for use in new studies. Study templates can be created using objects from the existing library, streamlining the creation of new studies.
Robust Data Export and Analysis
Data can be easily exported to SAS data sets for statisticians, supporting interim analysis. Built on powerful and robust Oracle technology, InForm has demonstrated proven scalability and performance, having successfully supported thousands of clinical studies across various development phases and patient populations worldwide.
Integrated Medical Coding
The system features integrated medical coding with the latest MedDRA and WHO Drug dictionaries. Coding is automatic but can be customized for drugs, therapeutic areas, sponsors, and geographic regions.
Oracle Technology
Utilizing state-of-the-art Oracle 11g 64-bit database technology, Oracle InForm ensures high performance and scalability. ClinDatrix performs annual dictionary upgrades under change control, maintaining full validation of the system.
Comprehensive Training
A self-paced e-learning system is used for training clinical site personnel, sponsors, and clinical research associates (CRAs) in the use of the system, ensuring thorough understanding and efficient use of Oracle InForm.
Why Choose Oracle InForm?
Oracle InForm’s robust features and scalability make it a trusted choice for thousands of clinical studies worldwide. Its advanced data management capabilities, flexible study design, and superior reporting functionalities provide a comprehensive solution to streamline clinical trials and enhance data accuracy.
Oracle InForm offers a solution that not only meets the demands of complex studies but also enhances the overall efficiency of the clinical trial process. Here’s why your organization needs Oracle InForm:
- Efficiency in Complex Studies: Oracle InForm’s ability to handle complex study designs, including those with multiple treatment arms and varied assessment schedules, makes it an indispensable tool for modern clinical trials. Its adaptability ensures that data is captured accurately, regardless of the study’s complexity.
- Data Integrity and Compliance: With embedded data management workflows and sophisticated edit checks, Oracle InForm ensures data integrity throughout the trial. This capability, along with risk-based monitoring and protocol amendment features, keeps your study compliant with regulatory requirements.
- Scalability for Global Studies: Oracle InForm’s proven scalability means it can support your studies, regardless of their size or geographic scope. Whether conducting a small, single-site study or a large, multinational trial, Oracle InForm provides the reliability and performance you need.
- Actionable Insights: The advanced reporting capabilities of Oracle InForm give you the insights you need to make informed decisions throughout the study. With over 150 operational reports and the ability to create ad-hoc reports, Oracle InForm provides a comprehensive view of your study’s progress and outcomes.
How ClinDatrix Enhances Oracle InForm
While Oracle InForm is a powerful tool, its full potential is realized when integrated into the robust infrastructure provided by ClinDatrix. ClinDatrix has invested heavily in proven and proprietary systems to ensure the safety, integrity, and reliability of client data. Here’s how ClinDatrix takes Oracle InForm to the next level:
Quality Assurance and Compliance
At ClinDatrix, quality assurance is not just a priority—it’s a fundamental aspect of our operations. Our clinical research systems, including Oracle InForm, are fully validated (IQ/OQ/PQ) to meet all regulatory agency requirements. This validation ensures the system operates within a secure, parallel processing environment that complies with Good Clinical Practice (GCP).
Rigorous Change Control
We govern all computer systems manipulating clinical data at ClinDatrix with stringent change control procedures. These procedures, which include documented SOPs and strict approval processes, ensure that any changes to the system, even minor ones, are carefully managed to maintain system validation and data integrity.
Secure and Validated Environment
ClinDatrix operates in a fully secured facility that complies with FDA regulations and GCP standards. Our GxP systems, including Oracle InForm, are protected by documented safeguards, ensuring your clinical trial data is secure, validated, and compliant with all relevant guidelines.
Disaster Recovery Planning
To further safeguard client data, ClinDatrix maintains an active disaster recovery planning and testing program. Our disaster recovery site, located 240 miles from our primary facility, ensures that data is protected and can be recovered quickly in the event of an emergency.
Expert IT Support
ClinDatrix employs a dedicated team of IT specialists who are responsible for sustaining our systems’ validation, reliability, and functionality. This expertise ensures that Oracle InForm operates at peak performance, supporting your clinical trials with the highest level of accuracy and efficiency.
Why You Should Turn to ClinDatrix
While Oracle InForm provides the technological foundation for successful clinical trials, partnering with ClinDatrix ensures you get the most out of this powerful system. Here’s why you should turn to ClinDatrix:
- Unmatched Expertise: ClinDatrix’s team of IT specialists and clinical research professionals bring a wealth of experience to every study. Our expertise in system validation, quality assurance, and data management ensures that your clinical trials are conducted with the highest level of accuracy and compliance.
- Commitment to Quality: At ClinDatrix, quality is at the core of everything we do. Our rigorous change control procedures, secure facilities, and validated systems provide the foundation for successful clinical trials. We go above and beyond to protect your data and ensure your study complies with all regulatory requirements.
- Tailored Solutions: ClinDatrix understands that every clinical trial is unique. That’s why we offer tailored solutions that meet your study’s specific needs. Whether you require advanced reporting, risk-based monitoring, or protocol amendment support, ClinDatrix has the expertise and technology to deliver.
- Full-Service Partner: ClinDatrix provides comprehensive support throughout the clinical trial process, from study design to data analysis. Our partnership with Oracle InForm ensures you have access to the best technology and the most experienced professionals in the industry.
- Ongoing Support: At ClinDatrix, our commitment doesn’t end with implementing Oracle InForm. We provide continuous support throughout your clinical trial journey, ensuring your data remains secure, your systems stay validated, and address challenges swiftly. Our team of experts is always available to assist with system updates, protocol changes, and any other needs that arise, giving you peace of mind and the confidence to focus on what matters most—advancing your research.
Partner with ClinDatrix for Clinical Trial Success
Oracle InForm is a market-leading EDC system that offers unparalleled adaptability, efficiency, and compliance for clinical trials. Combined with the expertise and infrastructure of ClinDatrix, it becomes a powerful tool that can help you achieve your goals. By choosing ClinDatrix, you’re investing in technology and partnering with a team dedicated to the success of your clinical trials. Let us help you navigate the complexities of clinical research with confidence and precision.
ClinDatrix Technology
