State of Safety & Pharmacovigilance – 10 essential capabilities of “Safety Platform of the Future”

It is amazing that I am able to put out my third blog post of “State of Safety & Pharmacovigilance” series in three consecutive weeks. In previous posts we talked about Top 5 challenges in Safety & PV and Platform Vendor Landscape.

In this post I would like to touch upon the key capabilities required for a platform to be considered “Safety & PV Platform of the Future”. My definition of such a platform goes like this. “An integrated SaaS platform that is built to support end-to-end Safety & PV process, agile to meet current & future regulatory quality & compliance requirements, built with best technology available to reduce total cost of ownership”. I will focus on what is required to make such a platform a reality from a functional & non-functional capabilities perspective

For my list I have looked at a platform that is capable of providing end-to-end functionality that includes:

1. Case Intake
2. Case Processing & Expedited Reporting
3. Aggregate / Periodic Reporting
4. Compliance & Operation Analytics
5. Signal Detection & Management and
6. Benefit – Risk Management

From a non-functional requirement standpoint, I looked at core platform capability that cuts across the functional areas.

1. Software-as-a-Service: Traditionally safety platforms were licensed to be installed by sponsors & service providers on their infrastructure. However, this has created tremendous challenges in maintaining the currency and compliance of the platform. Not to mention the increased total cost of ownership. I believe, with the increased adoption of Cloud for GxP solutions, a platform built or offered as a SaaS solution will definitely address these concerns in most cases, if not all.

 

2. Integrated, yet Modular: Solutions exist for key functions listed above (at least for CP, AR & SDM) from leading commercial tool vendors. However, life sciences companies were left to deal with the complexities of integration when they want to build a “best-of-the-breed” eco system.

While I am a big proponent of adopting an end-to-end integrated platform, I certainly understand and appreciate any decisions to build a best-of-the-breed ecosystem. Hence, the need for a platform that is integrated, yet provide ability to leverage specific modules and integrate with other solutions through micro-services, E2B or other means. Integration capability is also required for cross-functional integration with systems of record in Clinical, Regulatory, Quality, Manufacturing & other functions.

3. Automation, out-of-the-box: Ability to automate activities across the business process. I understand this is a much hyped and possibly touchy subject for many. Yet, there is definite progress being made by various organizations. I would refer you to a very good source, for more details and additional learning, published by TransCelerate through their “Intelligent Automation Opportunities in Pharmacovigilance” initiative.

In this context I am using automation to include Robotic Process Automation (RPA), Artificial Intelligence (AI), Machine Learning (ML), Natural language Processing (NLP), Natural Language Generation (NLG) etc. Also, automation can be leveraged across the functional modules identified above (e.g. Case Intake, Case Processing, Signal Detection & Management etc.)

4. Unified Intake: While some leading commercial platforms had Intake capability, it has been lacking in others. Many customers have built solutions creating maintenance challenges. My ask is not just to add AE intake functionality but make it a unified intake capability.

What do I mean by unified? Apart from Adverse Events, many organizations deal with Complaints (Devices & Combination Products) and Medical Inquiries. While the systems of record for each of these functions is different, many a times these are received through channels like literature search, response centers, social media etc. Imagine a unified intake module that can process these structured, semi-structured and unstructured inputs, triage using AI/ML/NLP, automatically create a case, complaint or medical inquiry and route to the corresponding system of record (I will elaborate further in what such a capability would mean and the benefits thereof in a separate blog post soon.)

5. Next-gen Signal Detection & Management: Signal Detection & Management is a critical function of Safety & PV to deliver on the promise of “Benefits outweighing risks” associated with any product (Drug, Device, Vaccine etc.). Many of the available tools in the market leave customers wanting more. The reasons are many but to mention a few, the algorithms used are outdated or need an upgrade. The diversity of data sources is also increasing. The need to incorporate Real World Data (RWD) is becoming imminent. There is also scope for leveraging automation technologies (AI, ML, NLP etc.) to proactively identify signals through the entire life cycle.
6. Operational & Predictive Analytics: While there is some operational analytics capability in leading commercial platforms in the market today, they definitely lack predictive analytics. In my opinion, ability to derive insights from the operational performance of an organization in terms of turnaround times (subject to local laws & regulatory requirements), regulatory reporting compliance, first-time right etc. is invaluable and necessary to drive efficiencies.

Given the capabilities being delivered by various analytics tools available in the market, I believe the commercial tool vendors can build predictive modeling capabilities. With this capability we can prepare our teams better in handling aspects like seasonality of cases, increase in case volumes with new product approvals etc. This could go a long way in managing team capacity or demand management for outsourced service providers, where applicable.

7. Benefit – Risk management: This is a very critical and essential part of product management in Life Sciences. Yet, there isn’t a notable solution available in the market, purpose built to address this need. In many cases customers resort to a document management solution with excel spreadsheets to go with it. Imagine an integrated solution that helps manage Risk Management Plans more efficiently and can integrate with Signal Detection & Management which in turn can be leveraged to more efficiently manage actions to close the risk associated with any signal detected. This capability could also extend to managing FDA REMS requirements for those products approved as such.
8. Standardized & Self-service Reporting Capability: In many organizations Aggregate & Periodic reporting is achieved through custom data marts/warehouses. While there are published regulatory requirements by FDA, EMA, PMDA etc., the commitments may vary from company to company and product to product. Hence, there is a need for elegant solution that provides built-in standard reports that are configurable with minimal effort and yet support ability to validate the reports where needed. Also, the ability to provision self-service capability will reduce manual effort and thus need for dedicated teams waiting for request to come-in before they either execute pre-written SQL scripts or create new scripts to deliver the required data to business teams. This capability will also improve capability to support regulatory audits & inspections, which in most cases are demanding & stressful for everyone involved.
9. Collaboration: This is another umbrella term I am using to meet multiple capabilities lacking in many leading commercial platforms. It includes flexible workflows to deal with case processing for global and Japan reporting. It also includes ability to efficiently manage documents (like PV agreements, PSMF etc.) in collaboration with partners. It includes ability to collaborate on periodic reports that may need to be authored, reviewed and approved by multiple people within and outside of Safety & PV organization.
10. Digital: Digital may mean different things for different people. However, in this context I am referring to the ability of the platform to handle things like device scalability (mobile based case reporting, intake) etc. This may not be a need for all the customers, but ability to configure such features and scale-up or down as needed will make it a versatile platform and will qualify as “platform of the future”.

Digital also means ability of the platform to integrate with sensors & wearables in a clinical setting and make data from these available to PIs or HCPs who would then be able to include it while reporting potential AEs. This may include ability to attach Audio & Video as source while reporting AEs so that on the other end the intake process is capable of processing such file formats, identifying AEs and processing the cases.

State of Safety & Pharmacovigilance: Platform Vendor Landscape

In my last post, State of Safety & Pharmacovigilance – Top 5 challenges, I shared some of the key challenges industry is facing in terms of growing volumes, harmonizing processes, meeting compliance needs, legacy technology and need for innovation.

In this post we will look at the platforms available in the market beyond Oracle Health Sciences Safety Cloud and Aris Global’s LifeSphere Safety. The idea is to surface some of the other products that have been around for a while, but did not receive wider adoption. We will also look some new products being introduced and are gearing up to disrupt the market.

While it has been a duopoly of Oracle and Aris Global, as good as these products are, they are not able to fully meet all customer needs. Some of it is the curse of productization and the challenge thereof in fulfilling all the requirements, a lot of it has a to do with products that are not flexible and configurable to scale to varying needs of small as well as large customers.

With that said, now let’s take a quick glance at the platform landscape. I would like to highlight three trends emerging in the Non-Argus/ARISg pool of products. Based on the origins of these products my categorization of these are:

1. Product Expansion Driven (PED): Extending of product line by platform vendors that have traditionally played in non-Safety & PV space
2. New Product Development(NPD): Investments by niche consulting companies with products to compliment or compete with existing products from leading vendors. Also includes products born out of transformation/automation initiatives. They are on the cusp of extending their Intake automation solutions to a full-fledged safety database, complemented by other tools to achieve full safety suite
3. Service Expansion Driven (SED) : Vendors that have been traditionally providing Safety & PV IT or BPO services that have identified an opportunity and developed products

The table below summarizes the list of vendors, big and small, that fall into the above categories:

S. No.	Vendor	Category	Details
1	Veeva Vault Safety Suite	PED	Native SaaS solution Extending Vault platform to deliver Safety Vision to develop end-to-end safety suite Safety module to be part of broader platform
2	eNNOV’s PV-Works	PED	Has a suite of products in clinical, quality, regulatory & safety Known for their content management products in Quality & Reg PV Works is the safety suite
3	Generis CARA Safety	PED	Primarily content management platform vendor Multiple products in regulated content management space Extended platform to cater to Safety & PV
4	AB-Cube SafetyEasy	NPD	Developed new product Offers end-to-end suite Predominantly leverage by SMB customers Available as a SaaS solution
5	RxLogix PV Suite	NPD	Started with complimentary solutions to existing safety databases End-to-End capability with Argus or ARISg as safety database
6	IQVIA Vigilance Platform	SED	Traditionally providing CRO services Foray into product development Platform announced
7	Genpact Cora PV	SED	Traditionally IT and Business Process consulting service provider New Investment in platform development
8	Deloitte ConvergeHEALTH Safety	SED	Traditionally IT and Business Process consulting service provider New Investment in platform development
9	Accenture INTIENT Platform	SED	Traditionally IT and Business Process consulting service provider New Investment in platform development
10	TCS ADD	SED	IT and Business Process consulting service provider New investment into platform development

Please note that the above list is a compilation of platforms available in the market for Life Sciences organizations to consider. I recommend customers to go through thorough evaluation before selecting a platform that works best for their needs.

In my next post in this series on “State of Safety & Pharmacovigilance”, I will share my thoughts on “Safety & PV Platform of the Future” to address the “Top 5 Challenges in Safety & Pharmacovigilance”.

Appreciate you feedback and suggestions. Would love to hear your experiences with any of the platforms listed above or if there are other platforms I should consider adding to the list. Thank you and stay safe.

State of Safety & Pharmacovigilance : Top 5 Challenges

Safety & Pharmacovigilance, as stated in many of my previous blog posts, is a critical function for any Life Sciences organization. This function deals with the most important stakeholder in the industry i.e. patient. Safety, along with Efficacy, is one of the most important aspect of any medicinal product. In a series of posts, I want to take stock of the state of Safety & Pharmacovigilance market. I will start with some of the challenges industry is facing and look at platform vendor landscape. I will also share what a Next Generation Safety & PV Platform of the future looks like, in my opinion.

This post identifies 5 top Business and IT challenges, based on my experience consulting with clients across the globe:

1. Increasing Case Volumes and Diversified Data Sources: Adverse Events (AEs) keep increasing every year. This is evident in case volumes being reported to the regulators like FDA (FAERS public dashboard). There is also an ever-increasing number of data sources that organizations have to scour for AEs. While some of them have proven to be not so effective (i.e. social media) but others have been found to be invaluable (i.e. EHR/EMR). These two trends mean increasing costs of safety surveillance year over year. This puts organizations in a tough spot with pressure on budgets.
2. Process Standardization and simplification: Despite substantial efforts, across many organizations, simplified and harmonized business processes are yet to be accomplished. For example, a global business process is still a holy grail in many organizations. Some companies have two (2) different safety databases (one for Global and one for Japan) because they could not agree to a simplified, global process. This problem is also exacerbated by lack of capability in technology platforms.
3. Legacy Systems & Tools: Many of the companies have legacy version of safety platforms. Biggest reason for this is prohibitively high cost associated with upgrades. Typical frequency of upgrades is 3 – 5 years, whereas the platform vendors put out a new version almost every year. So, it is always a catch-up game on the currency of platforms
4. End-to-End Platform: There is a dire need for a platform that meets end-to-end (Intake to risk management) capability with cross functional integration to Clinical, Regulatory and other processes. The limited options available to the industry have a lot of functional/feature debt. This forces companies to build customizations that are costly and complex to maintain. It has also resulted in manual processes for workarounds.
5. Innovation: While life sciences industry in general is embracing Digital Transformation, Safety & PV is still lagging. Life sciences R&D is typically conservative, and rightfully so, in adopting innovations like AI, ML & NLP due to regulatory & compliance needs. With the increase of Digital Health/ Medicine and diversified sources of safety data there is a definite need for investment in innovation across the board. This includes innovation by safety platform vendors as well as other stakeholders in the value chain.  

REMS Journey from Inception to Latest FDA Guidance

In lieu of the recent draft guidance issued by FDA on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies document Using Structured Product Labeling” earlier this month, I thought of taking a trip down the memory lane to revisit how we got here on REMS.

The following diagram provides a snapshot of the timeline: REMS-Journey

For those keen to understand how REMS documents get converted to SPL elements, you can refer to this presentation on “REMS Standardization via Structured Product Labeling (SPL)” by Adam Kroetsch, Policy and Informatics Advisor, Office of Program and Strategic Analysis,  Center for Drug Evaluation and Research from October 5, 2015.

I have talked about REMS in my past blog posts, specifically about “Implementing FDA REMS ETASU Requirements using a BPM Suite“. Feel free to check it out. I will have more to say on this topic in my future blog posts in relation to impact of the new guidance and how to prepare for it.

Three reasons you should upgrade to Oracle Argus Safety 8.1.x

Oracle Argus Safety is a leading Safety & Pharmacovigilance platform in the market. Oracle has been able to successfully move many sponsors from diverse drug safety platforms it built (Oracle AERS) or acquired (PhaseForwards’ Clintrace and Relsys’ Argus) to Argus Safety, making it their strategic safety platform of the future.

Upgrade to latest version of the platform has always been a challenging task for many sponsors, given the complex nature of configurations, customizations and integration with various clinical, regulatory and safety applications in the R&D ecosystem. Typically it takes anywhere between 1 to 3 years for customers to get onto the new release after the version is available. Of course this time line will change with the amount of changes the new version brings to the table. The impact of change will also determine the duration of the upgrade project/program. This has been the root cause for many customers delaying the upgrades in the past. Not to mention the cost associated with these upgrades.

The latest release, Argus 8.1 addresses new regulatory compliance requirements, functional enhancements and biggest of them all technology platform currency. In my opinion,these three things are key drivers to upgrade to Argus 8.1.x .

Regulatory Compliance Requirements: The new E2B (R3) reporting guidance for transmission of Individual Case Safety Reports based on Health Level-7 (HL7) messaging protocol provides an advantage to capture more data with increased granularity and frequency. ICH E2B(R3) is a mandatory regulatory requirement that all safety organizations need to be compliant with, in future. Different Health Authorities have different milestones / timelines for compliance. At this time it appears that PMDA (Japan) deadline of April 1st 2019 as the most impending one. Also many sponsors have implemented interim solutions to process EMA’s Eudravigilance ICSRs that are available in E2B (R3) format. The interim solutions have to be done away with and what better than meeting this requirement through the core platform. Also, electronic Vaccine Adverse Event Reporting System (eVAERS) and electronic Medical Device Reporting (eMDR) requirements, connected with E2B (R3) and important initiatives for Vaccines and Med Device sponsors are key requirements to be complied with.

Bug Fixes and Functional Enhancements: As with any of the past releases, Oracle has also addressed a lot of requirements pouring in from sponsors to fix some of the existing issues and enhance the platform to meet some new requirements. In 8.x there are over 350 Issues fixed. New Expedited Report Updates adhering regulations are added. There are also various Case Management Updates. There are a bunch of changes specifically targeting Argus J (i.e. Japan). Japan Development Safety Update Report (JDSUR) is enhanced replacement for ‘Clinical Study Periodic Safety Report’ (CSPSR). Also, ability to convert existing CSPSR report to JDSUR on Copying the Existing Report has been added. There are updates to PSR, ReSD, Global Lock and local data locks and local case data locks specifically for Japan.

Technology Platform Currency: Many existing technology platforms that support Argus platform have become outdated in the last few years. This has led to Oracle adopting newer versions of Windows, Oracle Database, OBIEE, Axway Interchange, Oracle B2B (new) etc. Also, some of the legacy technology platforms like Windows 2008/R2 are going out of support, not to mention premium support for Argus 7.x as well. The Technology platform changes themselves should be a big reason for sponsors to consider upgrade to 8.1.x.

More specific details around the bugs/enhancements as well as specific software versions in the technology platform currency can be found in Oracle Argus Safety 8.1 Release Notes.

As always, your feedback and comments are welcome. I would be very interested to hear from consultants and technologists in the trenches, driving the upgrades. Also from sponsors who are considering upgrades in near future (or not) .

P.S: This is my first post after a very long hiatus. But I plan to share my thoughts and opinions more often going forward. Thanks for your support and feedback.