The Journey to the Cloud for Life Sciences Content Management Part 1: Industry Forces and Cloud Adoption complies with ISO 20252
Page Table of Contents Executive Summary 2 Industry Forces in Conflict 3 Risk Aversion in Life Sciences: Protecting Vital Intellectual Property 4 Public Cloud Adoption in Life Sciences 5 Page 1 of 6
Executive Summary Life sciences organizations spanning large global companies down to smaller industry players all face the same burdens of increasing cost pressure, fragmenting value chains, expanding regulatory compliance and exploding content volumes. The need for stronger regulated content management has never been more important to ensure compliance and fast time to market in an increasingly complex and challenging environment. Smaller and mid-size companies certainly have additional cost and resource constraints, but they still need proven industry best practices in this area to maintain compliance of their documents. The task for companies of all sizes is to rationalize their pressing business needs with the available vendor solution options. Given the benefits and rapid growth of cloud- and Software as a Service (SaaS)-based applications in the broader IT industry, is that now a viable option for regulated content management in the life sciences? To address this question, ORC International conducted a two part analysis into cloud adoption and the business needs of, and solution options for, regulated content management in the life sciences. In part one of the analysis, ORC found three leading factors forcing pharmaceutical and biotech companies to be somewhat reluctant to fully embrace public cloud solutions. Life science industry forces are in conflict Regulated content management is essential Adoption follows the path of least regulation Some factors, like increased cost and time-tomarket pressure, make cloud solutions more compelling, while other factors, such as industry fragmentation and globalization, make it less so. Pharmaceutical and biotech companies have a pervasive need for regulated content management, and their risk averse nature has slowed the embrace of cloud as they voraciously protect their most vital intellectual assets. When companies have adopted public cloud, SaaSbased solutions for life sciences content management, they have traditionally done so in lesser regulated functions such as sales, marketing and HR, where information is less risky. Page 2 of 6
Industry Forces in Conflict Key ORC Takeaway: Cost pressures, an increasingly fragmented value chain, and expanding global compliance requirements are exerting conflicting influences on cloud adoption. With an average cost in the range of $1B to $5B to bring a drug to market 1, it is not surprising that pharmaceutical and biotech companies are increasingly looking for ways to keep costs in check while maintaining strict compliance and minimizing business risk. To that end, outsourcing is on the rise; recent research finds 59% of life sciences companies outsourcing late stage clinical trials to Clinical Research Organizations (CROs) 2. While reducing cost, it also increases reliance on 3 rd party participation in key and sensitive business processes performed outside of the firewall. At the same time, there is staggering growth in the amount of content generated in the process of bringing drugs to market. From a documentation standpoint, firms need to plan for, collect, track, secure and maintain a multitude of content across highly regulated, inter-company business processes. A typical clinical trial alone can generate 25,000 documents 2 ; and this is just one of the many processes in the broader life sciences business operations. There is a high level of compliance complexity for life sciences companies operating globally. Public cloud solutions work best for smaller companies that are geographically limited. It is much harder, and more costly, for organizations to use cloud in one area of the business while using different solutions in others. Program Manager Mid-Market Specialty Finally, as companies expand into new geographies to maximize product revenue opportunities, their needs may change based on unique regulatory environments of the locales they conduct business in. When it comes to compliance, there are many different requirements around clinical information, regulatory submissions and generally introducing and sustaining drugs in those local markets. Pharmaceutical Company 1 Forbes, August 11, 2013 2 FierceBiotechIT, Jan 27, 2014 Page 3 of 6
Risk Aversion in Life Sciences: Protecting Vital Intellectual Property Key ORC Takeaway: Pharmaceutical and biotech companies have a pervasive need for compliant regulated content management and their risk averse nature has slowed the embrace of cloud as they voraciously protect their most vital intellectual assets. More so than their non-regulated business counterparts, it can be said that content represents the lifeblood of the life sciences business. Virtually every major functional area in life sciences has a high dependency on the ability to effectively manage content. Many functions have the need to track-and-trace document-based information from a regulatory standpoint. In other words, they need regulated content management for the key functions and for all parties involved in business processes through the extended value chain. Huge conglomerate or emerging start-up, effective management of regulated content is a basic need. It is easy to understand the importance of security when considering the types of intellectual property and proprietary content life sciences firms produce and manage on a day-to-day basis. Some of the key content categories and assets aligned to the major regulated functions are listed in Table 1. While this list is the most common set, companies also have their own unique and proprietary assets as well. Table 1. Sample of lifeblood Documents by Function Life Sciences Function Research and Development Clinical Trials Quality and Manufacturing Content or Asset Types Regulatory Submissions Clinical Study Reports Drug Formulation Drug Product Specifications Clinical Trial Master Files Master Randomization List Subject Identification Log Contracts Standard Operating Procedures Master Manufacturing Documents Records and Certificates Validation Documentation Reference and Training Content Page 4 of 6
It is not at all a stretch to call these the most vital intellectual property for life sciences firms and offers a good explanation why many of these organizations are more risk averse when it comes to their IT solution approach. Regulations require a controlled method of management over a sponsor s proprietary information and inspections look for these controlled methods and provide judgment as to sufficiency of controls. Many companies want control over where information is stored and when upgrades take place. That said, as technology options for cloud deployment matures, even the more risk averse firms are investigating alternative deployment options in some of these content areas, but likely not all. Public Cloud Adoption in Life Sciences Key ORC Takeaway: Adoption of public cloud, SaaS-based solutions for life sciences content management to date has traditionally occurred in lesser regulated functions such as sales, marketing and HR where information is less risky. An issue beyond the regulatory aspect is that companies are not ready to part with their confidential documents, leaving them in someone else s hands. They want to avoid the legal issues altogether. Security is a big issue for public cloud adoption. Sr IT Project Manager Cardiovascular Research Foundation Conducting interviews with implementers and end users of pure SaaS solution provider customers, ORC research findings indicate that most SaaS deployments are for the lesser regulated business processes (CRM, Marketing, HR etc.) for which the material, while sensitive, is nowhere near as critical compared to the more regulated functions. In fact, of the twenty five deployments of SaaS-based life sciences content management analyzed, less than 15% were used for functions beyond sales and marketing. The primary benefit of the deployments center around the collaboration among the internal and external parties and driving efficiency and productivity of document-intensive processes. Not surprisingly, small and mid-size organizations are the ones who have been the early adopters of cloud offerings, finding the benefits typically associated with public cloud including rapid deployment, accelerated user adoption, and less reliance on internal IT resources. Despite the subscription pricing offered by SaaS providers, however, these Page 5 of 6
customers were mixed regarding the longer-term cost profile. With a considerable initial outlay and recurring costs based on growing volumes and storage, many did not find it dramatically lower cost than on-premise offerings. Larger organizations interviewed cited a number of concerns and impediments to embracing public cloud offerings including growing content volumes, concerns over file size limitations, the cost and time for migration from existing systems and their ability to integrate with internal applications and infrastructure. Finally, many expressed a concern around engaging and managing another vendor relationship for content management understanding that the content management capability footprint of the SaaS provider may only serve a few functional areas and may not be a holistic solution for them. Running multiple platforms for content management can dampen or even negate the benefits of the cloud deployment. It is easier for a small company to use a SaaS solutions with content management for a specific function, but it would be a huge challenge for a larger organization because it cannot cover the needs across the broader business. They would end up with a dual environment. IT Director Fortune 50 Pharmaceutical Company In Part 2 of ORC International s research and analysis on cloud adoption for life sciences, ORC will identify the business needs of both large and mid-size life sciences companies and provide a landscape of two unique classes of current day solution options for regulated content management. We will demonstrate why the journey to the cloud may not necessarily be the binary decision as it has been for other IT solution areas and why regulated content management maturity and solution flexibility might rule the day. Page 6 of 6