Digital Process Automation and Pharmacovigilance

Post by
Andrew Paier

Editor?s note: This guest post is the eighth in a series from Larry Taber, BP3?s Digital Strategy Officer for Life Sciences and Pharma.?Larry has over 32 years of deep pharmaceutical and biotech expertise ranging from discovery research to business development. He has over 17 years of leadership of international teams successfully partnering with over 100 companies. Larry is a proven business process problem-solving professional and trainer. He has completed Master Black Belt, Black Belt, and Malcolm Baldrige National Quality Award /Performance Excellence Examiner certifications. He is passionate about the incredible advances in medical science and the enablement that is being made possible for patients through digital technologies. He holds a M.S. in Medical Biochemistry from Indiana University Medical School and a B.S. in Chemistry (Magna Cum Laude) from Purdue University.]

Given the exponential rise in reported adverse events (AEs), automation in pharmacovigilance is now a necessity.? However, digital process automation (DPA) enables far more than just faster turns of the crank.? Let?s take a look.

It Does Reporting and Case Handling Better than Ever

DPA is already used by many for simple case reporting and processing.? It?s here to stay and it?s getting even better.? Digital multiple source channels can be used for intake of events.? What?s more, digital can solving one of the biggest issues, which is poor or incomplete information capture.? Smart forms and templates, dynamic questionnaires, and chatbots can ensure that patients and HCPs provide complete data ready for quasi-instant reporting to authorities in the correct E2B formats.? At the same time, duplicate reported events can be flagged.

Using DPA, case processing can be rapidly routed and that work can be executed either serially or in parallel for case triage, coding, medical evaluation, quality control. Simple tracking systems can also ensure that serious cases are expedited and reported within time limits.

Executing these fundamental processes of PV with digital technology allows companies to meet the growing volume of AEs, improve quality, and manage the cost of operations.

Adaptive Processing

DPA is useful for repetitive operations, but rules-based processing is where DPA really shines. ?For instance, DPA can utilize combinations of structured and unstructured data to perform ?cognitive routing.? This achieves adaptive processing according to a risk based approach so that the efforts of your medical and quality professionals are directed to the most important cases and highest risk products.

End-to-End Process Orchestration

Some companies are using digital technology at every step along the PV process.? When designed correctly, this allows for end-to-end process orchestration.? This also reduces effort and frustration for PV professionals by creating predictability and by facilitating easier access to information located in disparate databases.

Enhanced Communication and Collaboration

Digital process automation can serve as a means for facilitating collaboration during process execution.? Beyond general networking tools, purpose-built user interfaces, such as Brazos Portal, can be added as conduits through which stakeholders functions, global affiliates, partners, scientific teams, and HCPs interact in a more timely and seamless manner for task execution.? Within internal messaging, screen sharing, simultaneous authorship, sequential routings and reviews, and meeting planning can then be bundled according to process step or deliverable.

Visibility and PV Process Performance Management

Once digitally connected end-to-end, the entire process can be visualized using tools, such as the Brazos Portal.? Individual tasks, follow-up actions, can be assigned and tracked and readily visible to assignees and the overall process owner.? Overall work in process can be monitored for resource management purposes, and PV process performance metrics and other analytics can be continually collected and graphically displayed for improvement


Regulatory Reporting

Electronic submission of individual case records and aggregate reporting to regulatory authorities is the norm.? Doing so in conformance to the rapidly changing standards and guidelines is essentially impossible without digital technology and use of the cloud.


Enhanced Surveillance and Signal Detection

Extracting safety signals involves queries of large volumes of data residing in a large number of locations and a wide variety of data set types.? They include clinical trials, scientific literature, health care records, product literature and labels, and patient registries.? Most companies use digital automation for these tasks.

More recently, social media (e.g., Twitter, Facebook), physician Q&A sites (WebMD, MedHelp, Wellsphere, MDJunction), and quantitative self-help sites where patients voluntarily share and discuss their disease progressions and symptoms (Patientslikeme; MedHelp; CureTogether, SugarStats) have added to an already daunting process of surveillance and data mining.

This work is far, far beyond human capabilities.? It must be digitally automated and supplemented by Natural Language Processing and Artificial Intelligence.


Risk Management and Patient Reported Outcomes

Following on from the Surveillance and Signal Detection challenges noted above, experts believe that Risk Management and Patient Reported Outcomes will create the greatest transformation ever seen in pharmacovigilance.? Accordingly, companies need to act now to be digitally prepared.?The change is inevitable due to multiple driving forces:

  1. Higher regulatory standards regarding patient safety information
  2. New drug types and treatment modalities that are more targeted and genomic profile-dependent
  3. More direct use of patient reported data
  4. Accessibility of electronic health records
  5. Social media and greater emphasis by external stakeholders for value-based (real-world evidence driven) outcomes.

New Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), and their execution, will only be successful if PV professionals are enabled with digital solutions coupled with powerful statistical tools, such as artificial intelligence.

Deliberate incorporation of information from electronic health records along with more emphasis and access to patient reported outcomes completely reverse the paradigm of small amounts of spontaneously reported adverse events from patients, and changes the very nature of pharmacovigilance.

Digitally Integration with Other Systems - Internally and Externally

When digital processes are combined with business process management systems, it is possible to bridge to other business processes and quality systems, and COTS products such as Clintrace, ArisG, Argus, Trackwise, and Veeva. ?A recent scientific review found that there are over 108 ADE reporting systems containing 1782 unique reporting fields.? The sheer numbers of players and systems will drive the need to externally connect through secure means via the cloud.

DPA is the Only Path to the Next Generation of Pharmacovigilance Innovations

DPA is not about automating tasks.? It?s a new mental model for how companies think about the work they do and how they can remain agile.? The future for PV innovation will be driven by:

  • Data Mining of Multiple Big Data Sources
  • Artificial Intelligence
  • Cognitive and Predictive Analytics
  • Image and Natural Language Processing
  • Machine Learning Algorithms

Digital innovation is a necessary component of creating competitive advantage and bringing greater value.? In this case, it is about how PV professionals can extend their science and services across the entire pharmaceutical value chain, even at the C-suite level, by providing insight across the R&D value chain, safety in business development, and interactions with external stakeholders seeking improved outcomes.

Most importantly, it is about how you can supplement your team with the full potential of available technologies to improve the safety of patients.

What?s It Take to Make the Digital Transformation to the Next Generation of Pharmacovigilance?

Whether you are closing gaps in your legacy solution, bridging COTS pharmacovigilance products, or simply trying keep up with the fast pace of technologies, ?you need a partnership with a proven digital operations company that you can trust.? We are that company.

Contact us at if you would like to assess digital maturity or Pharmacovigilance process integrations.

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