Happy New Year from AgilePV


Happy New Year to Patient Safety and Regulatory Professionals. You are responsible for massive amounts of data, and the stakes are high—yet every day you work to keep treatments safe and patients informed.

At AgilePV, our goal started five years ago—to create a suite of software that can unify your responsibilities, providing you with better oversight and audit-readiness. With that in mind, in 2017 we expanded our tools to include more functionality than ever before, bringing more safety and regulatory practices into the AgilePV fold.

So, this year as you’re updating your spreadsheets and emailing your distributed colleagues, think of us. Because whether you’re managing ICSRs, Safety Signals, Safety Concerns or Safety Variations: we want to be there, making sure that your process is validated and harmonized across the board.

Patient Support Programs: Eating the Elephant

Across the board, Pharmaceutical companies are looking to reduce the amount of effort they put into case processing. Case processing comprises a huge amount of manual effort in pharmacovigilance, and with cases projected to increase by 20% every year, there has never been a better time to simplify.

With such a large goal in mind, how do we “eat the elephant?” Today we’re serving up your first course: patient support programs.

About Patient Support Programs

Patient Support Programs have become a vital part of the pharmacovigilance landscape. When it comes to patient engagement, there is no better option. In fact, PSPs and similar programs are consistently tied to improved adherence to prescriber guidelines, increased efficacy of the treatment, enhanced safety of using the product, and can even reduce the all-around healthcare costs for patients.

As pharmacovigilance entities are striving to reduce the attention they give to high-volume activities like adverse event case processing and manual aggregation of reports, having a resource like PSPs that improve patient engagement, communication and all-around safety is increasingly valuable.

So, where’s the rub?

Patient support programs can introduce a lot of complexity into the daily operations of your pharmacovigilance team. For one, Patient Care Providers must report adverse events gathered through the patient support programs.  According to AgilePV’s research, these cases can account for 25-40% of your total caseload, and like many solicited events they are generally non-serious, expected and listed.

Essentially, in an attempt to increase the attention into patient engagement, your PV team is also increasing their workload when it comes to more menial tasks like processing these adverse events.

Additionally, the vast majority of Patient Support Programs are provided by vendors, who each have different methods of recording adverse event reports and sharing them with you. PSPs often create too much data from too many sources for your operational infrastructure—a classic vendor management problem.  How can you streamline data sharing and reduce friction around case intake and pre-processing?


Join our Webinar:
"Patient Support Programs Solutions – Your first step towards automation" 

August 15th at 10:00 AM EST

Join us as we discuss methods we’ve found for lessening the workload. There has never been a better time to begin “eating the elephant” when it comes to automation. Join us for our webinar August 15, where we’ll be serving up the first course: Patient Support Programs.

Risk Minimization in Modules V & XVI - Show, Don't Tell


Modules V and XVI are closely related regulations providing requirements for Risk Minimization Measures (RMMs) that you’ll need to account for in your RMPs.  Where Module V covers your routine requirements, Module XVI adds the additional punch—you now need to track not just implementation, but also the effectiveness of your RMP.  This can introduce complexity into your RMP strategy, especially given each of the EU member states’ varying requirements for RMM.  

Keeping an audit trail, tracking exactly what happened and when, can virtually eliminate the chances of audit findings, and goes a long way towards supporting Module XVI compliance.  Unfortunately, most companies are still using spreadsheets and Outlook reminders to track these obligations. In other words, since these organizations are still using manual processes, it is difficult to prove that the RMM tasks were done and done right.

Here’s 5 big things you can do to make auditing, tracking and managing RMM information easy: 

1.  Centralize Tracking

Creating one area where all stakeholders can update their own information reduces the work around tracking processes for compliance. Plus, by providing secure but simple access to that centralized information, stakeholders can upload and edit their information themselves.

2.  Automate Reminders

The first step to tracking your process is ensuring that users remember where and when to submit reports for the RMM. Automated reminders make sure that these materials are submitted on time—without the hassle of reminding your affiliates when Action Responsibilities are due.

3.  Find the Source of Truth

It isn’t enough to say a task is done. Managers need authoritative reports proving it has been completed on time. Making sure we know the Single Source of Truth for this information is key to Module XVI compliance.

4.  Quick metrics

A pharmacovigilance system should provide quick ways to look into your process, with dashboards and reports, helping you find which areas need the most attention quickly.  This way, we can appropriately address oversights, CAPA events and miscommunications before they are ever found by an auditor.

5.  Validate, Validate, Validate

Finally, a validated system will tell you what information has been added and when—vital to proving your company’s Module V and XVI compliance.

Thoughts? Email Katherine.Long@agilepv.com

Tracking your signals in EVDAS

So you found a potential safety signal in Eudravigilance EVDAS.....now what?

The EMA recently introduced and made available (to MAH's and national competent authorities) the Eudravigilance Data Analysis System (EVDAS). This is great news for companies and agencies who need advanced signal detection for post market surveillance. Included in EVDAS are tools to review case counts by demographics and even disproportionality analysis algorithms available for data scientists. 

Once your organization identifies a signal, then, to comply with Module IX Signal Management, you must pursue the signal and track your activities. Many organizations have experience with a signal management tool as either bundled with the in-house signal detection platform or most commonly just an Excel spreadsheet. Yet with EVDAS, there is no included signal management component. 

At AgilePV, we provide an online Module IX compliant signal management solution. Your organization can track all signals, activities, meetings, and even documents pertaining to your safety signal processes. So when you are searching for potential signals in EVDAS and need to start managing the upcoming tasks, take a look at the Safety Signal Tracker from AgilePV. 

Case Processing Evolution — Where do you fit?

In a webinar I gave last week, “Over Outlook? Simplify your PV mailbox with NLP technology,” I introduced a scale that I call “Case Processing Evolution.” These five steps cover what we’ve found repeatedly at pharmaceutical companies—where they’ve come from and where they’re going on the road to automation.  

In case you missed it, here are the five steps to automation.


1. Any Means Necessary

When companies are just starting out, they may find themselves in the “Any Means Necessary” Phase. You may be in this phase if:

  • Your company has no standardized way to accept reports—you’re just trying to manage them wherever they come in.

  • Your team is manually processing these reports— data validation is near impossible and your process takes a lot of manual work and direct monitoring.

  • You often feel that you’re just too busy to compile metrics or optimize the process

If this sounds like you, then it’s time to take a step back and start working toward the next phase.

2. Low Hanging Fruit

It’s not perfect, but it’s a lot better! These companies may not be using the newest technology, but they’re finding ways to make their process more effective:

  • Your company has started automating a few of their intake methods by adding electronic data entry from your vendors
  • Manual Processes are still there, but they’re getting smarter—e.g. personalized email folder on your shared inbox, color-coding incoming cases and other quick fixes

3. Process Automation and Fine-Tuning

This is where it starts getting good. Not only is your AE Intake Process fully digital, its also fully validated!

  • You have standardized processing with robust integrations with other data sources
  • Your process works on its own without a lot of clerical effort
  • Your centralized and digital process is easy to query for reports—or better yet, reports are fully automated as well.

4.  Incorporating AI

In the evolution of technology, AI (Artificial Intelligence) pops up towards the end of our timeline—but that doesn’t mean that it can’t support your processes in other stages of evolution. A well thought-out Natural Language Processing application can help you triage new cases for language, seriousness, and completeness without painful infrastructural changes.

5. Total Automation

In an ideal world, anything that could be done by a machine would be—from intake, translation through verification—the software would handle processing and only require human intervention when they’re needed most.

As we all know, today’s technology hasn’t gotten there – and neither have our regulations. That won’t stop us from dreaming though!

Thoughts? Email Katherine.Long@agilepv.com

Validated computer systems – a must for life sciences

For leaders in Pharma looking to implement a technology solution, one of the first considerations is validation—Can the system be validated, should it be validated, and what steps does it take to validate?

What does Validation mean?

Computer System Validation can be a complex topic—subject to many international regulations, proprietary internal policies, and industry best practices.

At risk of oversimplifying, it means that measures are put in place to ensure that the system or software produces accurate and consistent results. For software that handles certain important records, it also means that information is maintained with a full history of any changes, and an audit trail of the parties making said changes—this is the guiding principle of the FDA’s 21 CFR part 11, for example.

Why do our Customers Validate?

In our their own words, noncompliance is “just a mess if you are audited.”

To put this in perspective, the alternative to many of AgilePV’s products are home-grown solutions—generally a mix of SharePoint, Excel, and elbow grease that are all but impossible to validate. In these cases, Pharma companies must choose whether to risk non-compliance with validation rules, or not to store the records in these systems at all. (The phrase “a rock and a hard place” comes to mind.)

Frankly, these home-grown solutions are not exactly easy to manage if you face a safety inspection or an audit.

Working in a regulated industry for years, AgilePV takes validation of our products very seriously and understands the need for maximum traceability and accountability. Each module of the Agile PV Software package is extensively validated, covering all facets of the software. Every major release is tested and validated in-house by our own QA, not a hired third party contractor.

If you are still tracking your Risk Management plans in Excel, reconcile your AE Reports via email or simply need state of the art traceability to comply with audits or safety inspections, we are here for you.