Custom pharmacovigilance safety software

Abto Software
4 min readJun 21, 2023

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:

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:

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Abto Software

We empower customers business with innovative software by applying science, R&D, and own IP at abtosoftware.com