PHARMACOVIGILANCE AUTOMATION – Improving CRO Efficiency Through Automation


INTRODUCTION

Big Pharma drives demand for contract resource organiza­tions (CROs) by outsourcing up to 45% of research and develop­ment (R&D) activities. The global biotechnology and pharmaceutical services outsourcing market is set to grow to $108 billion by 2030 to meet these rising demands, putting pres­sure on CROs.

Many CROs believe they’ve reached a breaking point as they work to keep up with rising case volumes, data complexities, and changing regulations. To combat these pressures, CROs need ac­cess to modern pharmacovigilance (PV) automation that pro­motes flexibility, scalability, efficiency, and cost-effectiveness.



TRADITIONAL SAFETY PROCESSES AREN’T ENOUGH

Many CROs rely on tedious, outdated manual methods to handle the influx of safety data and process cases. Those tradi­tional workflows make it more challenging for CROs to accom­plish the following essential tasks:

Efficiently Process Data – The first steps in safety case processing involve extracting safety case attributes from source documents and populating that data into a database. Traditional, manual approaches typically require PV teams to carefully read incoming documents and forms before re-keying the data into a case-in­take system. This process involves expending manual efforts on redundant data entry and requires multiple stages of manual re­views and quality checks, resulting in an error-prone and monot­onous data entry flow.

Scale Cost-Effectively – Traditional workflows impair a CRO’s ability to process hierarchies, adjust to changes in volume, and introduce new services. In turn, this drawback makes it harder to scale operations and become a one-stop-shop vendor. While using legacy systems, CROs have to throw more human resources at increased case volumes, which isn’t sustainable long-term.

Identify Safety Signals – Discovering safety signals is a critical aspect of pharmacovigilance. A manual review of individual cases or data may make it challenging for PV teams to efficiently identify patterns, trends, or potential safety concerns. Organiza­tions may miss essential signals or face delays in detecting and acting upon emerging safety issues.

Meet Complex Global Operations – PV operations are subject to strict regulatory requirements and reporting obligations. Tra­ditional workflows may lack built-in compliance checks and au­tomated reporting mechanisms, making it harder for CROs to ensure compliance with evolving standards and regulations. Re­liance on manual processes can introduce errors, data inconsis­tencies, and delays in meeting regulatory deadlines.

By embracing modern tools and technologies, CROs can overcome these limitations and optimize their PV activities, lead­ing to the delivery of more value to their clients.

AN INDUSTRY NEED FOR AUTOMATION

Recent trends across the life sciences industry also create a need for faster and more accurate adverse events (AEs) reporting. Safety caseloads are increasing 15% year over year (YOY), on average. This increase can be attributed to a number of factors, including the following:

Changing Regulations – The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) continually up­date their safety data reporting require­ments. Increased regulatory scrutiny to ensure patient safety will continue driving the need for more PV capabilities and for organizations to review and revise their safety cases.

Rising Clinical Trial Complexities – More clinical trials require larger patient popu­lations due to the increasing prevalence of chronic diseases and the need for addi­tional data to support the approval of new treatments and drugs. Larger patient pop­ulations make clinical trials more complex as PV teams manage and track a large number of patients. Clinical trials are also becoming more globalized, with CROs conducting trials across study sites in mul­tiple countries. This reach requires coordi­nation between different teams and compliance with varied regulations. Addi­tionally, CROs are conducting clinical trials in numerous diverse therapeutic areas, which require a broader range of expertise.

Increasing Adverse Event Data – More cases – or patients experiencing “an AE of interest” – are emerging during post-ap­proval drug safety surveillance. During the monitoring of the safety and effectiveness of drugs currently available to the public, PV teams identify a need for preventive ac­tions, like changes in product labeling in­formation and, rarely, the re-evaluation of an approval decision.

Advanced technology in the life sci­ences industry also contributes to in­creased AE data. More organizations use electronic data capture (EDC) systems, al­lowing for the efficient collection of more data. Patients are also using social media platforms to report AEs. Social media em­powers patients to take an active role in their health by providing an outlet to share their experiences with treatments. This un­solicited RWD systematically adds valuable context to signals found in reported AE data sets. However, because technology makes reporting easier, there’s also a rise in the number of false or incomplete re­ports that need to be logged and processed.

Given these challenges, CROs need intelligent and innovative technology to help with growing case volumes.

DIFFERENT TYPES OF AUTOMATION

When considering which technology capabilities best align with their PV efforts, CROs should look at the following three types of automation:

Rule-Based Automation – Applies man-made rules to store, sort, and manipulate data. Rule-based automation best handles repetitive tasks, like duplicate checks.

Knowledge-Based Automation, ie, Artifi­cial Intelligence (AI), Natural Language Generation, or Machine Learning (ML) – Unlocks insights into large data sets re­lated to compliance and patient safety. Knowledge-based automation contains sophisticated algorithms that perform tasks requiring cognitive reasoning, visual perception, speech recognition, and deci­sion-making.

Knowledge-Assisted Automation, ie, Nat­ural Language Processing (NLP) or Ma­chine Translation – Combines the power of automation with human insights and expertise to achieve more efficient and ef­fective outcomes. Knowledge-assisted au­tomation addresses increased case vol­umes and can better handle structured or unstructured case sources. Examples of knowledge-assisted tasks include causality assessments or literature database screen­ings.

Modernizing Pharmacovigilance

Automation increases efficiency and provides benefits like greater process con­sistency, improved data quality, and the opportunity to shift resources to higher-value initiatives like PV analytics and ben­efit-risk assessment. However, technology shouldn’t replace all the work humans do. Instead, it should act as a means to help humans do their jobs better and transform safety from a cost center to a strategic pil­lar of innovation.

Software Development Using Artificial Intelligence/Machine Learning Models

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HOW AUTOMATION BENEFITS CROS

Before taking steps to implement au­tomation, CROs should consider the ad­vantages specific to their operations, which could include the following:

  • Reducing manual efforts and repetitive tasks.
  • Helping CROs comply with changing regulations while reducing the risk of in­consistencies and errors.
  • Ensuring distribution protocols adhere to each region’s regulatory require­ments.
  • Streamlining PV operations and reduc­ing the expenses and time associated with linear data processing.
  • Dissolving data silos that keep CROs from gleaning insights.
  • Allowing data streams from other sources or systems to connect, leading to better risk assessment and decision-making.

In practice, CROs use automation to extract information from inbound data forms, discover relevant safety data points, and annotate those data points from liter­ature articles. Leveraging automation to take care of those manual tasks frees PV teams to redirect their attention toward more valuable activities like understanding what those data points mean. Resources with high levels of specialization can be alerted when cases fall outside of prede­termined thresholds, which require hu­mans to make a decision using their judgment.

CHALLENGES OF ADOPTING AUTOMATION

Automation can be a valuable tool for CROs, but automating PV workflows isn’t always simple. CROs may have to navi­gate the following obstacles:

Training – PV teams must go through train­ing to strengthen their knowledge of auto­mated systems. This education can be a challenge if employees are under time constraints due to heavy caseloads or re­sist change due to a “we’ve always done it that way” mentality.

Integration – CROs must integrate auto­mated systems with existing PV systems and processes that often involve multiple teams, which can be complex and time-consuming.

Maintaining Data Quality – CROs need clean, accurate, and complete data to en­sure automated processes produce reli­able results. The best safety solutions include intelligent automation pre-trained with an incredibly extensive data set.

Ensuring Compliance – CROs must ensure their automated systems comply with reg­ulatory requirements, including those re­lated to safety reporting and data privacy.

Despite these challenges, CROs can successfully adopt automation with careful planning and the right automated safety solution.

SAFETY PRIORITIES FOR CROS

When replacing traditional workflows with a modern safety solution, CROs should seek a versatile cloud-based solu­tion that enables a single source of truth for improved data quality. An automated end-to-end solution should include the fol­lowing qualities:

Flexibility – Adapts to an organization’s unique requirements with flexible configu­ration of workflows, dashboards, and re­ports.

Speed – Increases the rate at which spe­cialized treatments effectively make it to market. With automation, CROs can see a 30% reduction in time to complete clinical site monitoring reports.

Scalability – Strengthens a full-service model with seamlessly scalable post-mar­ket safety operations.

Efficiency – Delivers more with the same resources with end-to-end production-ready automation. CROs can achieve up to 30% efficiency gains using automation solutions.

Always Up-to-Date Global Compliance – Expands a CRO’s serviceable market with support for all current and upcoming reg­ulatory standards.

Additionally, the fact that clinical trials are increasingly global can add to data challenges. A complete cloud-based clini­cal trial management system makes it easy for CROs to manage data centrally and thereby achieve cost savings.

TIPS FOR ADOPTING AUTOMATION

After choosing the right safety solution for their needs, CROs can follow these tips for adopting automation:

Assess Current Processes – CROs should assess the specific needs and pain points within their PV operations. By understand­ing current processes, CROs can start to pinpoint areas where automation can bring the most significant benefits, such as data entry, case processing, or reporting.

Start Small – CROs shouldn’t try to auto­mate everything at once. Instead, PV teams can start with a few key processes and scale up as they gain experience. A slower pace keeps employees from feeling overwhelmed and facilitates successful au­tomation adoption.

Provide Training & Support –
CROs must provide comprehensive training to employees who will work with automation tools. Education is crucial to ensure staff members understand automation’s benefits, know how it works, and can effectively leverage its capabilities. Ongo­ing engagement and communication throughout the implemen­tation process will address concerns and promote buy-in from all stakeholders.

Monitor & Evaluate – PV teams have to continuously monitor and evaluate the performance of their automation solutions. Key met­rics like processing times, error rates, compliance adherence, and resource utilization will help identify areas for optimization and improvement. Regularly assessing automation’s effectiveness in achieving defined objectives will facilitate necessary adjustments.

Embrace Continuous Improvement – CROs should also continu­ously seek opportunities for improvement by leveraging feedback from users and stakeholders. Regular assessment of automation’s impact on operations will identify areas for refinement or expan­sion. Embracing a culture of continuous improvement will maxi­mize the benefits of automation in CROs’ operations.

SUMMARY

More CROs realize the powerful impact PV automation can have on their operations. In fact, nearly 75% of life sciences or­ganizations say that the opportunity to have automated risk man­agement and safety signal detection would be beneficial or even game-changing.

With automation, organizations can designate fewer re­sources to process and sift through the majority of cases and data. CROs realize better outcomes because PV teams can work faster and smarter with reliable data at their fingertips.

Emmanuel Belabe, better known as “Manny,” has worked within ArisGlobal in a number of different roles throughout his 18 years with the company. During this time, he developed an approach that sought to educate clients on best practices for leveraging ArisGlobal products while advocating the best way to deliver additional value through the implementation of additional ArisGlobal solutions. This led to his current role of Product Owner for Safety Solutions, where he is responsible for implementing tightly integrated tools that fit within the company’s vision of providing a unified platform across all R&D domains.