Using artificial intelligence (AI) during intake and triage supports real-time insights to the nature and severity of cases being reported. It helps to categorize and prioritize, especially when there are adverse events (AEs).
What are adverse events?
Whether preventable or unpreventable, AEs are harmful or negative outcomes related to medical devices and pharmaceutical, biotechnology, and cosmetic products. They have a wide range of severity and are often associated with medication errors, medication side effects, equipment failure, or device failure.
Serious adverse events are a subset of AEs that pose significant risk like:
- Congenital anomalies
- Inpatient or prolonged hospitalization
- Significant or persistent incapacity or disability
- Death
Why Adverse Events Must Be Reported
Pre- and post-market studies result in safeguards for public health. Reporting adverse events and collecting safety data after products have been released on the market helps regulatory agencies evaluate product safety. AE reporting of rare effects, delayed effects, and effects in vulnerable populations provide valuable information for those evaluations.
For example, the U.S. Food and Drug Administration (FDA) provides resources to help investigators, sponsors, and contract research organizations (CROs) comply with laws and regulations for good clinical practice (GCP).
Similarly, Medical Device Reporting (MDR) is a post-market surveillance (PMS) tool used by the FDA to monitor device performance, detect potential safety issues, and conduct product assessments.
How are Cases Triaged in ProcessX?
ProcessX helps you optimize individual case safety reports (ICSRs) and PMS workflows and use advanced analytics insights to cultivate higher-quality operations. For example, in a safety intake scenario for pharmacovigilance and complaint handling, AI and machine learning are used to categorize and assess risk during AE intake. Natural language processing (NLP) redacts personal information based on permissions. AEs are consolidated into a single platform, then generative AI analyzes large datasets and non-structured outputs to compile reports.
Documenting an adverse event requires a case report form. An AE workflow can be created in ProcessX by the patient, a friend or caregiver, or a healthcare professional. Steps include:
- Reporter information
- General information
- Patient information
- Risk information
- Product details
The information gathered helps to determine if the AE could be related to an intervention. ProcessX uses AI and machine learning to categorize and assess risk during intake and to determine whether an AE should be reported to the FDA.
Using ProcessX, AEs are consolidated into a single platform, repetitive tasks and data entry are automated, and you’ll achieve greater efficiency and cost savings.
Best Practices for Adverse Event System Implementation
The ability to meet regulatory requirements for adverse event reporting can be a major pain point. Your reporting process may lack standardization or a single system for visibility and compliance. Best practices for implementing an adverse event system include:
- Analyze the “as-is” state of your current system and process
- Conduct a data review and clean it up before migrating data
- Identify errors and continue data clean up during the migration process
- Incorporate automation for case intake and triage
Still, AE case volume can be overwhelming. Multiple intake channels and languages require a throng of people to transcribe information to legacy safety systems.
ProcessX automates AE intake from sources like spreadsheets, phone calls, texts, emails, and social media. It uses language support to ingest data and streamline the triage process. AI helps to simplify event management and ensure that safety teams are used efficiently.
To support your digital transformation effort and scalability, ProcessX effectively handles adverse event reporting and management. AE workflows can be integrated into your current PMS workflows, complaint handling system, or safety database. (Or a combination of these systems.)
ProcessX includes early risk detection and an effective mitigation plan. It also helps your organization:
- Enable more efficient intake and reporting
- Exchange safety information in a timely manner
- Eliminate rework due to missing or inaccurate information
- Provide real-time AE status and supporting information on individual and collective cases
Choose USDM as Your GxP Managed Service Provider
Whether you’re considering outsourcing your adverse event management or you need help establishing comprehensive GxP-compliant processes, USDM delivers unparalleled domain expertise and service.
Clinical
Safety, efficacy, and integrity are non-negotiable in clinical trials. From Phase I trials to successful regulatory submissions, the experts at USDM have decades of industry experience to help make your clinical endeavors compliant with FDA regulations and international regulations like the European Medicines Agency (EMA).
Manufacturing
To implement the best manufacturing solutions in your organization and deliver products that are safe, effective, and free from potential harm, it’s time to automate. USDM helps you streamline processes and optimize your cloud-based GxP-ready technologies to achieve safety, quality, and reliability in pharmaceutical and medical device manufacturing.
USDM Cloud Assurance
USDM Cloud Assurance is a managed service subscription that incorporates decades of global regulatory experience and best practices to help your organization minimize its validation burdens. Especially helpful for the Computer Software Assurance (CSA) methodology, Cloud Assurance does extensive automated testing.
The Cloud Assurance managed service for ProcessX includes:
- An annual audit of ServiceNow
- The initial validation of ProcessX on the Now Platform
- Ongoing release management and automated testing for customer-specific ProcessX deployment
You also get the full story on your validated state using the Cloud Assurance Digital Experience (Dx) web application. It helps you clarify the complex by measuring, monitoring, and managing the compliant state of your cloud-based GxP systems.
To learn how ProcessX can be integrated with your existing quality system and automate your case intake and triage process, contact USDM today.
