Leaders in drug\/medical safety have been stuck between a rock and a hard place for years. On the one side, complexity is dramatically increasing – expanding case volumes, biologics, new regulatory requirements, greater focus on combination therapies, and complex partner agreements. And, there is an increasing need for leaders to make safety decisions quickly with the most available data. Striking that perfect balance between effective risk management and maintaining access to medicines \u2013 especially for the patients who will benefit from them the most. On the other side \u2013 legacy, installed, on premise applications are costly, inflexible and siloed – ultimately restricting growth, innovation, and the ability to optimize business processes. Additionally, obtaining and assigning adequate budget to maintain both legacy and new systems is a challenge.\u00a0These two opposing forces in safety, demand change but restrict it at the same time. The end result is that drug safety has fallen significantly behind, not evolving into its rightful place as a strategic enabler within the biopharma industry.<\/p>\n
In speaking with leaders of drug safety and pharmacovigilance, there is no argument that they need to catch up first, so that they can innovate in the future. The question is – how? <\/p>\n
The pressures on safety will only increase over time as scientific breakthroughs continue and our understanding of human pathophysiology expands. With legacy, installed, on premise applications as the only area of opportunity for removing drug safety from between a rock and a hard place \u2013 the \u201chow\u201d \u2013 is a pretty grim outlook.<\/p>\n
The good news is the technology disruption that will enable drug safety to catch up and innovate is becoming available in the form of cloud applications. Cloud solutions work across organizational silos as well as enable collaboration between companies and partners.<\/p>\n
“As pharmacovigilance organizations maximize efficiency gains from offshoring and outsourcing, innovation is needed in new areas to continue improving safety operations, analytics, and ultimately outcomes. Safety data is key to this transformation \u2013 enabling greater and more timely insights, automation, and better decision-making for our patients. We must aspire to precision medicine being applied in safety as we do when we consider efficacy of our medicines. To achieve this, we need to break down our silos of information by moving towards centralized information that is easily and securely accessible,\u201d said Dr. Edwin J. Tucker, Chief Operating Officer, Acerta Pharma.<\/em><\/p>\n We\u2019re not discussing a theoretical vision that is decades in the future. Cloud transformations have already taken place in clinical, regulatory and quality for drug development, and nearly all other aspects of the business – CRM, back-office operations, and HR across most industries. \u00a0<\/p>\n In this blog series, we\u2019ll discuss the fundamentals of what is a true cloud application, why it\u2019s important, and how it will enable innovation for drug safety. \u00a0<\/p>\n The most basic and most critical question to ask of a cloud application is \u201chow many software versions are running in production?\u201d If the answer is anything other than one, then you should avoid that solution. Now, let me explain why this is such a critical question.<\/p>\n The reason is quite simple – software providers must spend an ever-increasing portion of their development effort on fixing and supporting multiple versions of their software, running on premise at a customer or in hosted environments, rather than investing in the future.<\/p>\n These multiple versions are commonly numerous old versions running on installed, on premise customer environments, or multiple versions running in a supposedly \u201ccloud\u201d offering. While organizations often claim \u201ccloud\u201d in their model \u2013 this is really just on premise applications managed offsite in a hosted fashion and having many of the same challenges as the on premise deployment model. <\/p>\n For each version of the application, the software vendor must spend effort on fixing bugs, supporting, building, testing, and deploying security patches as well as invest lots of additional effort just to ensure each software version will still run as expected. The problem becomes exponentially more complicated when you consider integrations between applications that are running different software versions, as any integration has to support every combination of existing versions. <\/p>\n Managing old or multiple software versions is very similar to managing debt.\u00a0As time goes by, the debt continues to grow with interest. As the debt grows, you are forced to spend more and more money paying the debt rather than buying the things that you want. <\/p>\n Similarly, in the world of on premise legacy software, as the number of software versions increases, more of the company\u2019s effort is spent on fixing bugs and maintaining multiple versions rather than building new capabilities. This on premise dilemma boils down to a trade-off between fixing old vs. building new. Over time, the burden drastically slows the improvement of software and stifles innovation.<\/p>\n A true cloud solution only runs one software version and is therefore free of these challenges and overhead. Issues are fixed once and only once, while the vast majority of investment is made in delivering innovation and new functionality. With a single version of the application, customers of a true cloud application realize the benefits of best practices and new capabilities driven across the industry. True cloud solutions lead to better, highly tailored software with better quality and stability. The \u2018innovation enabler\u2019 is the single software version running in the cloud.<\/p>\n Imagine a world in safety where the challenges and cost of upgrades are eliminated. As regulations are announced or updated, the application is automatically improved to support these new requirements with no effort by the customer. For the vast majority of people reading this blog, I understand that this seems like a fantasy world. However, this is a standard expectation of cloud applications.<\/p>\n Upgrades for on premise safety applications are extremely expensive \u2013 for both software and hardware. For each released version of the software, the customer performs a cost-benefit analysis to answer the question, \u201cis the upgrade worth the effort?\u201d\u00a0Analysis is performed on what the new upgrade will provide vs. how much money and effort it will take. The complicating factor in this decision is that companies also need to comply with new regulatory requirements by a specific date, forcing customers to perform costly upgrades just to achieve compliance. Once completed, the next regulatory change will force yet another costly upgrade \u2013 an endless loop of cost and dependency. The cloud offers a much better solution.<\/p>\n In the cloud, upgrades are seamless as new functionality simply becomes available in a validated and compliant state. The customer can choose when to enable specific features in each of these releases \u2013 minimizing impact and providing control to the customer. Customers are future proofed against unforeseen regulatory changes, ensuring their solution evolves with the industry.<\/p>\nThe Innovation Enabler – One Version for All<\/h2>\n
The End of Upgrades: Stay Compliant and Current in Perpetuity<\/h2>\n