Cloud-Based Pharmacovigilance Safety Software

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ABTO Software

Safety surveillance is the key component of efficient drug regulation. It is fundamental to protecting drug manufacturers, drug distributors, and end-consumers.

Safety surveillance is the key component of efficient drug regulation, clinical care, and public health programs. Comprehensive post-market safety surveillance is fundamental to protecting drug manufacturers, drug distributors, and end-consumers.

The quality and efficiency of new pharmaceutical products must be demonstrated before their approval. Despite this, many adverse drug effects – including morbidity and mortality – have been detected when some pharmaceutical products have been used. It is therefore crucial that safety compliance of new medicine be monitored during both clinical trials and the medicine’s launch on the market. But how do you ensure alignment with the stringent regulations of authorities such as the EMA and FDA?

Safety Requirements in the United States and Europe

The established pharmacovigilance system is an extensive system primarily designed to ensure patient safety. It includes the detection, assessment, understanding, and prevention of adverse drug effects and other medication-related problems.

The acknowledged pharmacovigilance system in the European Union is governed by the European Medicines Agency (EMA), which has been established to:

– gather information from all available sources (case reports, epidemiological analysis)

– analyze data

– identify signals

– assess risks.

The EMA obliges marketing authorization holders (MAHs) to conduct imposed post-authorization compliance studies. Regarding certain authorized medicinal products, responsible MAHs might have additional requirements to monitor pharmacovigilance databases, which can include gained findings in a relevant PSUR (Periodic Safety Update Report).

In the United States, the responsible pharmacovigilance system is the Food and Drug Administration (FDA). The FDA requires manufacturers, packaging providers, and distributors to establish and maintain accurate records and submit those to the FDA so that it can monitor unexpected effects associated with pharmaceutical products

The FDA requires manufacturers to submit post-authorization safety reports on a regular basis.

  • Quarterly for the first 3 years after approval
  • Annually thereafter

Post-Authorization Reporting Data Management

The identification and management of so-called safety signals is essential for marketing authorization holders. The inability to detect safety signals hinders further safety assessment. Most commonly, responsible MAHs use the following sources.

  • Databases containing medical records, which include patient age, gender, morbidity, and other data
  • Databases containing administrative claims

An electronic healthcare database with systematic or automated data collection presents an alternative source. It can be integrated with official disease registries, prescription databases and functionary mortality registries to ensure more accurate data capture. Within the framework of MAHs’ compliance management, this approach might ensure:

  • continuous monitoring of relevant pharmacovigilance data
  • data quality, integrity, accuracy, and legibility
  • source verification
  • endpoint validation
  • right selection of techniques, linkage methods, and search strategies
  • justified assumptions
  • data management and coding
  • record validity.

Core Challenges for Safety Compliance

Biopharmaceutical organizations are producing and distributing efficient medicines at an unprecedented rate. Still, with billions being invested in research and development, bringing brand-new high-quality medication to the pharmaceutical market comes with grueling challenges.

The main compliance roadblocks can be reduced to:

  • inconsistent and spontaneous reporting
  • priorities shifting towards efficacy, not safety
  • analytical limitations
  • reporting limitations.

Another roadblock is the ever-increasing volume of information originating from different sources, along with the increasing pressure to carefully review such sources.  And then there’s the demand for integration and management of ever larger amounts of data that are used to evaluate safety signals.

These challenges are hindering regulatory compliance, causing:

  • low competitiveness
  • detained growth
  • reputational damage
  • financial loss

AWS-Based Pharmacovigilance Safety Software

The platform we suggest is cloud-based SaaS safety software providing access to multiple virtual databases to facilitate data processing for subsequent data analysis and reporting.

  • Data management
  • Signal management
  • Data validation and cross-field checks
  • Case creation, modification, monitoring, and access
  • Advanced analytics
  • Expedited and periodic reporting (in both E2B (R2) and E2B (R3) formats)
  • Electronic signatures
  • Electronic submission
  • PSUR submissions, PBRER and DSUR documentation
  • eMDR XML file creation

By incorporating useful tools, customized AWS-based SaaS safety software can help 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 other content)

The concept we suggest conjugates multiple smart and scalable products to leverage the potential of modern cloud technologies, such as AWS-based pharmacovigilance safety software by Abto Software.

Some of the services that might be integrated to harvest maximum benefit include the following.

  • AWS Lambda — data processing
  • AWS KMS — key creation and management, data encryption, HMACs generation
  • Amazon CloudWatch — infrastructure and application monitoring
  • Amazon OpenSearch — real-time monitoring, log analytics, and search
  • Amazon Cognito — easy and secure authorization
  • Amazon Kendra — unified search across multiple structured and unstructured repositories
  • Aurora repository — a fully managed, simple, reliable, and cost-efficient database
  • Darktrace vSensor — cyberthreat detection
  • Amazon Comprehend Medical — data capturing and processing (medical records, discharge summaries, test results, and other supportive documentation)
  • Document Understanding Solution — data search, discovery, filtering and extraction along with workflow automation

Safety Software to Boost Business Growth

Cloud-based compliance software might automate manual routines, providing for increased productivity. The AWS-driven safety solution can help you handle clinical trials (from small Phase I to large Phase III and IV), as well as adverse post-marketing events ensuring adherence to good pharmacovigilance practices (GVP).

When adopting computational technology, you leverage the following.

  • Cloud Computing

Enjoy accessibility, accelerated flexibility and scalability, optimized collaboration, advanced security, and other business benefits that come with adopting advanced technology in healthcare and pharma.

  • Process Automation

Significantly minimize manual activities by incorporating artificial intelligence, in particular machine learning and natural language processing.

  • Data-Driven Decision-Making

Easily access valuable insights from diverse data sources to leverage data-driven decision-making.

  • Regulatory Compliance

Confidently detect, analyze, manage, and trace safety signals to ensure regulatory compliance.

Safety Software Business Value

Cost Efficiency

A cloud-based compliance software might diminish operational expenses by optimizing waste management and budget reinvestment.

Operational Efficiency

The AWS-driven safety solution might boost overall performance by providing:

  • reduced time and cost
  • increased performance and interoperability
  • streamlined communication and collaboration
  • eliminated bottlenecks.

Productivity Optimization

As stated by McKinsey, about 60% of productivity could come from digitalization and automation of processes.

Post-authorization analysis and reporting can be notably improved by implementing computational technology to handle the identification of risks, as well as the evaluation of measures to be taken.

Risk Management

According to recent research, the cost of adverse medication events to global healthcare systems is estimated at over $42 billion. The majority of adverse drug events related to VTE treatment are hospital-acquired, with costs estimated to range between:

– €1,5 to €13,5 billion in the European Union

– $7,5 to $39,5 billion in the United States.

By adopting computational technology, responsible authorities can eliminate financial damage by quickly detecting, investigating, and remediating emerging issues.

Compliance

A pharmacovigilance service platform can turn obligatory reporting into an efficient and convenient practice by helping companies immediately respond to incidents and problems using automatically synchronized runbooks. Companies can also seamlessly support compliance processes using automation, best practices, and templates.

Security

The suggested service platform can optimize operational security by:

  • encrypting data
  • filtering data to restrict content access
  • gathering data in the form of logs, metrics, and events
  • analyzing data to quickly identify threats.

Continuous Workflows

Computational technology ensures instant, uninterrupted monitoring without human surveillance. The solution might accurately gather information from all available resources, analyze data, identify signals, assess risks, and create comprehensive reports.

Advanced Analytics

Modern tools easily detect relevant patterns and deliver valuable insight without constant human intervention. The solution can streamline data collection and analysis providing for data-driven decision-making.

Employee Satisfaction

According to Kofax’s research, about 22% of productive employee time is wasted on repeated manual tasks. Utilizing the suggested pharmacovigilance safety software, a company can optimize employee performance, improving employee satisfaction and motivation.

Business Sustainability

According to DownToEarth’s publication, an increase from about $150 billion in 2019 to over $1 trillion by 2030 in clean energy investment is needed to put the world on track to reaching net-zero emissions by the year 2050. Using AWS-based software means minimizing the amount of water commonly used to cool data centers, respectively returning more water to communities.

Final words

In general, there are numerous opportunities pharmaceutical organizations might leverage.

  • Business automation (ERP and CRM platforms)
  • Telemedicine and telehealth solutions (for example, smart chatbots)
  • Predictive analytics (enterprise tools for discovering data patterns and making accurate predictions)
  • Recommendation systems (EMR and EHR systems)

What’s more, pharma companies can enhance operational processes by adopting the following.

  • Artificial intelligence (ML, DL, and NLP)
  • Computer vision
  • Optical character recognition (OCR)
  • Blockchain technology

Regarding regulatory compliance, most businesses are under great pressure to control large workloads and evaluate numerous sources of information. They also have to manage rapidly changing requirements. All of this has to be done with limited resources. Pharmacovigilance management software can help:

  • seamlessly control safety signals
  • continuously track submission deadlines
  • assure uncompromising data reliability
  • ensure compliance with industry-specific standards.