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Digitize pharmacovigilance safety operations through automation and analytics
Safety surveillance is the key component of efficient drug regulation, clinical care, and public health programs. Comprehensive post-market safety surveillance is fundamental to protect drug manufacturer, drug distributor, and end-consumer.
Speaking about pharmacovigilance compliance, we see many providers facing some industry-specific challenges associated with manual workflows, different sources of information, and ever-changing industry requirements. We see the opportunities in facilitating pharmacovigilance management in adopting end-to-end automation, enhanced by computational technology.
Safety compliance’ core challenges
Biopharmaceutical organizations are discovering and producing novel medications at an unprecedented rate. But still, with billions being invested in research and development, biopharmaceutical companies face some grueling challenges when bringing their products to the dynamic market.
The roadblocks can be reduced to:
Inconsistent and spontaneous reporting
Priorities shifted towards efficacy, not safety
Analytical limitations
Unstructured information
Lacking access associated with patient privacy
Reporting limitations
Sensible delays between occurrence and documentation
Poor documentation
Another factor to address is the increasing volume of information that originates from various external sources. In addition to the great pressure coming from numerous sources to be accurately reviewed, it is also the overhanging challenge of integration and management of instantly growing volumes of information.
Given these and other modern-day challenges, more and more leaders in the healthcare and pharma industries are adopting:
Suggested pharmacovigilance safety software
We are strongly confident that adopting digital transformation is privileging biopharmaceutical organizations. Handled automatically, data entry and processing, signal detection, case analysis and reporting, and submission can ensure utmost productivity.
Our services are wide-ranging, from chatbots to standalone and comprehensive management applications — no matter the complexity, our engineers can build custom pharmacovigilance safety software, precisely tailored to meet your needs and goals.
The solution we suggest might comprise:
Multi-tenant access
Role-based access
Data management
Signal detection and management
Data validation, cross-field checks
Case creation, modification, monitoring, and access
Dictionary updates (MedDRA, VeDDRA)
Statistical calculation (PRR, ROR)
Expedited and periodic reporting (E2B R2 & R3)
Aggregated reporting (PSUR, DSUR, PADER, PBRER)
Electronic signatures
Electronic submissions (built-in gateway)
The solution we have in mind should process structured and unstructured documents:
Full-text and abstract publications
Scientific literature (dissertations, theses)
Systematic reviews
Competitor analysis
Regulatory reports
Unpublished materials (case reports, clinical studies, safety findings, and more)
We see unlimited potential in leveraging computational technology to benefit biopharmaceutical companies. The outcomes are considerable and comprise resource and operational efficiency, performance optimization, and compliance with acknowledged regulatory standards.
Our expertise:
Machine and deep learning
Natural language processing (NLP)
Cognitive computing
Semantic search
Use your pharmacovigilance platform to mitigate potential obstacles — delayed approval and time-to-market, reputational damage, financial penalties, and deficient therapeutic efficiency.
Help your pharmacovigilance professionals keep focus on what matters most — patient health and safety — without compromising business productivity.
Safety software’ business benefits
End-to-end automation
Healthcare and biopharma organizations can minimize manual routines by implementing artificial intelligence to optimize data acquisition and generalization.
Digital transformation
Healthcare and pharmaceutical companies can enjoy increased productivity by leveraging advanced technology for accurate photo/audio/video recognition, anomaly and pattern detection, predictive analysis, and precise, data-driven recommendations.
Third-party integrations
By integrating the software with authoritative healthcare databases, disease registries, prescription resources, and functionary mortality databases, our team can ensure more accurate data capture.
Regulatory compliance
By sticking to the industry-specific standards and certifications, our engineers can help confidently detect, analyze, manage, and trace safety signals to ensure regulatory compliance.
Medical standards and certifications
Delivering solutions that process electronic protected health information, we prioritize regulatory compliance. Caring about patient safety, we cover risk assessment, data storage and minimization, appropriate disposal, encryption, authentication, disaster recovery, access control, and more.
HIPAA compliance
The HIPAA compliance requirements outline the safety standard for sensitive data protection in healthcare. Those companies that deal with sensitive data processing must implement physical, network, and process security measures to ensure HIPAA compliance.
Patient information to protect commonly comprises:
Names
Addresses
Contact information
Identifying numbers
Diagnosis and treatment information
And more
HL7 standard
The HL7 is representing the standards associated with data transfer between different healthcare providers. More specifically, the HL7 helps bridge existing gaps between various telehealth and telemedicine solutions, and optimizes data exchange.
FHIR standard
The FHIR is an integral part of HL7’s newest standard known as Fast Healthcare Interoperability Resources. More explicitly, the FHIR helps accelerate information retrieval, update, storage, and exchange to ensure streamlined interoperability between systems, and is thus essential to provide better management within a digital environment.
Key takeaways
With the right software, pharma organizations:
Seamlessly control safety signals
Continuously track submission deadlines
Assure uncompromising data reliability
Ensure compliance with the industry-specific standards
So that they achieve:
Cost and time efficiency
Operational efficiency
Productivity optimization
Regulatory compliance
Pharmacovigilance software is beneficial to strategic pharma companies moving towards business digitization. Modern technology automates adverse event monitoring, risk management, regulatory compliance, and other critical processes, eliminating potential reputational and financial damage.
Besides custom pharmacovigilance software, pharma companies might adopt: