The Taboos of Implementing Automation in Pharma

Debunking the Top 5 Taboos of Automation in Pharmacovigilance

The volume and type of safety data that needs to be collected, analysed and reported continues to rise annually.

These heavily manual processes rely on people to have not only received initial training, in order to process reports, but continued training to ensure up to date activities are being performed globally. This places strains on Pharma and any outsource Partner to ensure high quality and costly training to ensure data accuracy and timeline compliance.

In the world of drug safety, the topic of innovation and Pharmacovigilance Automation is often met with great scepticism, underpinned by long-standing myths that can be found across numerous industries governed by strict legislation, where unforeseen problems have resulted in more failures than successes.

Understanding the taboos of implementing automation in pharma is key to upgrading legacy workflows. For Global Pharma to truly evolve and enhance global patient safety within the modern era, it is essential to demystify these taboos in order to leverage the benefits that automation offers.

Overcoming the Taboos of Implementing Automation in Pharma:

Understanding the main taboos of implementing automation in pharma allows safety teams to take a pragmatic approach to digital transformation:

• Cost: Perceived high initial investments deter companies, ignoring long-term savings and efficiency gains. Implementations do not have to be expensive, especially when targeting Pharma Process Optimisation.

• Time: Concerns about lengthy setup and onboarding periods often overlook the eventual optimisation and streamlining of processes. Setting up Pharmacovigilance Automation does not need to be lengthy or require large numbers of internal staff to move into production.

• Effort: The perceived complexity of integration and training can seem daunting, but this is more fear of the unknown than the actual effort required.

• Benefit-Risk: Apprehension towards potential risks that automation may introduce instead of focusing on the tangible benefits, with no consideration for risk mitigation strategies. Utilising performance statistics to compare the rewards of automation versus the previous manual process not only demonstrates the decision to automate but demonstrates to higher management enhanced compliance, data accuracy, and cost-savings.

• Culture: Resistance to change and adopting AI in Drug Safety can hinder progress. Fundamentally, in any Organisation is the insight to evolve in order to improve and not become extinct.

Addressing the taboos of implementing automation in pharma head-on ensures these barriers—which stem from simple misconceptions—can be overcome by strategic planning and a focus on both short- and long-term advantages. By demystifying the taboos of implementing automation in pharma, the following strategies for success can help your Company move towards a more effective, streamlined approach that enhances patient safety.

Strategies for Success:

• Clear Implementation Roadmap: Creating a clear implementation roadmap involves drafting a comprehensive plan that outlines each step of the automation integration process. This roadmap should detail the objectives, timelines, and responsible parties for each milestone, as well as setting realistic, achievable goals that can be adjusted in line with progress reviews. This may also involve a phased introduction so that the implementation matches the specific Company needs – rather than a more generic application.

• Stakeholder Engagement: Stakeholder engagement is vital in overcoming barriers when tackling the taboos of implementing automation in pharma. This involves fostering an environment of open dialogue and collaboration amongst all parties impacted by the automation process to ensure the implementation is personalised to the type of products the Company has (e.g. Drugs, Devices, vaccines etc…). This includes employees, management, regulatory bodies, and technology providers.

• Phased Approach: Adopting a phased approach to implementing AI in Drug Safety enables organisations to manage change more effectively, allowing for each stage of the process to be optimised before moving to the next. This facilitates continuous learning, adjustment, and improvement, whilst also reducing the risk of disruption and enabling more precise tailoring of the system to meet specific drug safety needs.

• Comprehensive Training: Prioritising comprehensive training programs is crucial for ensuring employees are well-equipped to effectively utilise any new automated system. This involves designing robust training that covers both the technical aspects of the new tools and operational changes made to existing processes.

• Performance Monitoring: Performance Monitoring involves establishing key performance indicators (KPIs) to assess the efficiency and effectiveness of Regulatory Compliance in Pharma. This approach facilitates continuous oversight of system performance, whilst also ensuring the automated solution meets or exceeds the outlined objectives for safety data management (accuracy; compliance; ease of use; cost-saving).

• Risk Assessment and Mitigation: Risk assessment and mitigation in the context of implementing automation within drug safety involves the early identification of technical, operational, and regulatory risks. Maintaining strict Regulatory Compliance in Pharma requires detailed mitigation plans addressing issues such as system compatibility, data security, and user adoption.

• Change Management: Implementing change management involves strategic planning and communication that fosters a culture embracing innovation. Drive Pharma Process Optimisation by engaging with stakeholders at all levels to understand and address potential concerns and provide clear information on the benefits and impacts of the automated solution.

• Regular ROI Assessment: The implementation of regular ROI (Return on Investment) assessments is critical when validating the financial and operational value provided by automated solutions. By periodically measuring the ROI, Companies can ensure the automated solution aligns with both commercial and safety objectives.

Overall, overcoming the taboos of implementing automation in pharma is essential for achieving the objectives and goals being set by governing bodies worldwide.

As an innovative provider of global clinical and post marketing drug safety services, our team is well versed in the benefits of automation – we even have our very own automated solution: R.A.P.T.A.R.® Reporting! Naturally, R.A.P.T.A.R.® encompasses all of the aspects discussed above to ensure that any implementation is quick, comprehensive, simple, and cost-effective.

Contact Us today for an introductory meeting or learn more about our core Pharmacovigilance Services and Regulatory Intelligence solutions.