Five reasons you should start using BPM for regulatory submissions

1.  Reduce cycle times and increase efficiency
There’s no need for the last-minute rush to get documents completed and submitted on time. In fact, you would be surprised by how many companies have very little understanding of how their documents are produced, reviewed and approved before they are submitted. BPM helps companies capture, analyze, understand and optimize critical submission process data, letting you get the job done faster and more efficiently, while ensuring you are meeting all submission deadlines.

2.  Complete process visibility
With BPM, you can know exactly where you are in your process at anytime. You can pinpoint the exact process you wanted automated, understand what it does and the interrelationships of the people, systems and technologies it involves, and optimize the process in a way that gives you the best advantage. Leveraging these capabilities users are able to initiate next steps, track deadlines and set up alerts to signal when specific users must take action based on clinical data becoming available. In addition, BPM processes can be easily updated and improved without requiring revalidation of other systems (e.g., Document Management, CTMS).  

3.  Better manage resources and roles
Social BPM capabilities allow you to define your users and what skills, training, certifications, and capabilities they have to ensure the right task is being assigned to the best person to complete it in the shortest amount of elapsed time. Work can be routed to the most appropriate employee, keeping in mind their current workload, to ensure projects don’t pile up and deadlines are met whether they are down the hall or across the globe.

4.  Establish universal metrics and standards
Real-time, personalized dashboards give you the ability to monitor and track the entire document creation, compilation and submission process. From planning, document writing, scientific review, QA and approval and issuing – you know who needs to complete and approve a task at any specific time. You can also generate customizable reports on different processes, establish performance metrics and see how you’ve improved your regulatory submission processes.

5.  Global accessibility
Web-based BPM suites give you the ability to access a wealth of information anywhere, eliminating geographical barriers. Work can be assigned to different users by adding a role attribute for users’ locations – ensuring people with enough hours in their work day and the right skill set can complete a task. Globalizing your customer operations not only helps you gain access to everything you need anywhere in the world, but also cuts down on operational costs. This feature gives companies the ability to truly leverage their global workforces to gain strategic advantage by effectively creating more working hours in a day.

A great BPM suite has the power to cut costs, increase productivity and transform the way your business operates. Stay tuned as we continue to discuss BPM’s influence within the pharmaceutical industry and how the combination of BPM and enterprise content management (ECM) can improve the way you get submissions done.

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Metastorm has a track record of success in the Life Sciences industry, helping some of the world’s largest pharmaceutical companies— including Allergan, AmerisourceBergen and PfizerWyeth—understand, improve and automate their business practices to prepare and respond to new regulations and competitor innovation. 

For more information, check out our Life Science solution page, where you can download Metastorm’s Aggregate Spend Management overview, request a demo, and watch an onDemand webinar.

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Before it even passed as legislation, Allergan proactively took steps to meet the mandates listed in the Physician Payments Sunshine Act and ensure that technology was in place to support overall corporate compliance and risk management efforts.  In doing so, Allergan implemented BEACON – a formal compliance and reporting program subjected to regular reviews, built on Metastorm BPM.  Rather than just focusing on reporting, Allergan chose a Business Process Management (BPM) solution to ensure it had better insight and control over its underlying business processes, as well as the ability to proactively analyze and making ongoing improvements.

In an article published by CIO Magazine last week, How Botox Battles Compliance Wrinkles, Allergan CIO Sue-Jean Lin discusses how Allergan was able to meet its new compliance burdens using Metastorm BPM.

For more information about Metastorm’s Aggregate Spend Solution, I encourage you to sign up to watch a free demo and explore our Life Sciences solution page.

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First of all, the revenue leakage problem is purely an operational issue – the drugs have already been discovered, approved, marketed and sold so most of the ‘hard part’ has been done. Unfortunately, in this space pricing is not simple. Almost all healthcare products are ultimately paid for by someone other than the end customer – the patient. This of course results in a complex web of regulations, government pricing, managed care formularies and tiers and wholesale distributors – just to name a few.

To that end, Metastorm has experience working with and developing process solutions for all of the players involved (including the United States government), and can help your organization too. Our technology has the ability to solve your organization’s revenue leakage problem, and more importantly, the fundamental issue plaguing the industry as a whole.

According to IDC, 4.4% of all pharma revenue, which equates to $11 billion annually, is lost to revenue leakage. This is a staggering figure considering that only the top 15 companies in the entire life sciences space generate that level of total revenue. Just think of what that number is relative to your company’s business!

To eliminate this unnecessary cost burden, pharma manufacturers need to automate the processes by which they communicate pricing information to their wholesaler trading partners. While many companies have an electronic data interchange (EDI) solution in place to address the issue, the IDC numbers tell a different story.

Most companies have found clever ways to use statistics to make it appear that the revenue leakage problem doesn’t exist in their organization. For example, many commercial contracting departments cite 98-99% success/accuracy rates for pricing. While those are impressive numbers, and should be commended, the flipside tells a different story – one of unnecessary profit loss in need of a solution.

Consider the same statistic another way: a 99% accuracy rate means that minimally 1% of total revenue is in dispute (i.e. chargebacks), or written off because of other operational and reconciliation issues. Any manager/director would love to lead a project that could reasonably promise to deliver 1% of existing revenue back to the bottom line. For any company with over $1 billion in total revenue, that’s a minimum return of $10,000,000 per year!

Sound too good to be true? It isn’t, and Metastorm has the experience and customer successes to prove it.

Our business process management (BPM) suite of software tools has been used by multiple companies in the space to deliver these types of results to their organizations. With Metastorm BPM you can automate these processes to submit and update pricing between a manufacturer and wholesalers, then provide both trading partners with a combined audit trail to ensure that pricing information is sent immediately, and that both parties have complete visibility (at a line item level) into every price and pricing/eligibility change.

These capabilities first ensure prices are updated prior to the contract effective date (eliminating chargebacks related to the timeliness of information), and second that when discrepancies do occur that both companies’ representatives have the same view of the same information for each transaction (minimizing the time required to resolve the issue). Both of these benefits seriously increase your bottom line by eliminating dollars going out the door unnecessarily while also providing the added benefit of reduced processing time, which frees up resources for more value-adding activities.

But don’t just take my word for it. I invite you to review our customer testimonials and other solution information to see for yourself how Metastorm has, and can solve the pharmaceutical revenue leakage problem and can improve the financial health of your organization.

Want to know more? Check out our life sciences solution page, and read this article about how Metastorm helped two major pharma’s collaborate on chargeback management. 

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Ethan Smith is the Director of Life Sciences Solutions at Metastorm where he oversees business and account development and solution creation for Metastorm’s global life sciences customers, partners and prospects.

Ethan has extensive experience in business process consulting in the life sciences industry. His areas of expertise include enterprise BPM strategies as well as the utilization of Metastorm BPM® and Metastorm ProVision® to establish Process Centers of Excellence. He has driven process initiatives across research and development, sales operations, incentive compensation, physician spend management and compliance functions. Prior to Metastorm, Ethan spent over 10 years in process consulting for the life sciences and insurance industries.

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According to the corresponding release this number is “the equivalent to total revenue for a top 20 pharma simply disappearing each year.”

The culprit? Revenue leakage.

According to the release, one of the major sources of revenue leakage, which costs pharmaceutical companies 4.4% of their overall revenue per year, is chargeback discrepancies. The release also states that “63% of manufacturers believe chargeback-related revenue leakage is a serious problem. This is up nearly 25% from a similar survey in 2006.”

With these staggering numbers it is very apparent that pharmaceutical companies have a huge problem on their hands. Fortunately, there are technologies available that can alleviate revenue leakage, and help these companies realize significant ROI along the way.

 For example—one of America’s largest pharmaceutical services companies, which ranks among the Fortune 25, has utilized the functionality of Metastorm BPM® to streamline and automate its contracts management and chargeback processes as well as over 175 other process across the enterprise, enabling it to:

• Establish more efficient and accurate tracking capabilities,
• Reduce chargeback disputes,
• Rapidly and efficiently  respond to changing market conditions, and
• Improve transaction transparency and supplier collaboration.

With the help of Metastorm BPM, these and many other benefits have been realized, enabling this company to achieve an exponential return on its investment, and helping it to avoid revenue leakage from poor process management.

Want to know more? Watch this customer video testimonial, and read this solution sheet.

You can also check out the Solutions for Life Sciences page on our website.

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Needing to coordinate clinical submissions with a global workforce while meeting FDA pharmaceutical guidelines, the company decided to use Metastorm BPM to create a 24 x 7 automated lifecycle of its clinical submissions. Deploying BPM, the company was able to generate metrics and reports quickly, increase employee productivity and decrease the standard turnaround time required to submit reports to the FDA while handling all document preparation offshore.

Below a senior systems analyst delves further into the advantages of using Metastorm BPM in his global clinical team.

Please visit Metastorm’s Web site to learn more about its solutions for pharmaceutical companies.

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