Jennifer Goldsmith, Veeva Systems

The dramatic reduction in process steps after adopting a cloud-based

						document management system. Credit: Veeva

		It is well known that clinical research takes years and costs billions of dollars, just to get to the point where a drug is approved. [1, 2] More delays can occur as the drug developer readies a commercialization plan and execution.

		IT systems have become an essential part of managing the voluminous data and documentation that flows among the developer, contract research organizations (CROs) and investigator sites. To date, most of these systems are on-premise implementations, and typically are not connected between clinical data, trial master file (TMF) systems, and, after approval, the content management systems for marketing and sales operations.

		The life sciences industry has long been saddled with on-premise systems that need to be highly customized for discrete areas of the business. Clinical, quality, regulatory, marketing and sales occupy separate siloes, disconnected by complex and stovepiped systems for content management. Yet the development of a product involves thousands of documents that span research to clinical to commercial and include partners and affiliates around the world. Gens & Associates’ RIM and affiliate benchmark study found that 40% of affiliate time is spent coordinating and managing regulatory information, with approximately 25% of that time spent on non-value-added activities, such as data re-entry. Confidence in the quality of information maintained in global systems is low. [3] The lack of authoritative, accessible systems results in inefficient communication between corporate headquarters and global affiliates—a significant drain on time and resources.

		At the same time, off-premise, cloud-based systems have become prevalent in many areas of consumer online activity, data mobility and a growing array of business functions, including sales operations and marketing. The potential exists to apply these cloud-based technologies to a broader range of life sciences activities. Reducing the flow of paper documentation, cutting steps out of the seemingly endless process of writing, reviewing and approving a document.

		It’s clear—now more than ever&mdash;that better internal and external content collaboration isn’t just nice to have; it’s the difference between bringing a product to market quickly, and struggling with complexity that can cause delays.

The journey from multiple siloes to single source

		Consider the typical process for making a simple protocol change. What should be a simple update spans many fragmented systems. To start, the protocol is created by a medical writer in a submissions-focused system, and then emailed to a colleague in clinical. The clinical user imports and then re-approves the protocol in the eTMF system. The study is executed and documents—including 1572s and Investigator CVs — are collected, sometimes across hundreds of sites. Those documents are exported and emailed back to the regulatory team, which packages and finalizes the submission and sends it to the appropriate health authorities.

		After approval of the product, the commercial team will often leverage some clinical study reports (CSR) from the submission to support promotional claims. To do this, they often export the CSR from the submissions system, add it to the promotional materials management system, approve the CSR again, and relate it to a claim. Now, imagine that there is a change in, or amendment to, even one of those documents. Determining the impact of the change and identifying all the items that require updating could take days or even weeks to accomplish. Even then, the results may not be complete.

		When all is said and done, this full process would span more than 25 steps, create duplicate information, and increase risk since updates to documents may not be fully propagated. There has to be a better way.

		The industry has tried to simplify the technology environment and streamline information sharing with varying degrees of success. Early systems consisted of custom integrations and resulted in convoluted applications that were loosely joined—driving users toward email workarounds or costly paper shipments. The industry also tried replicating content, copying documents from the main repository into multiple other repository instances. Invariably, backend databases crashed or became corrupted, resulting in the loss of critical information. Companies also attempted to maintain a single, monolithic repository with various applications working against it, making it exceedingly challenging to align governance and validation schedules between different groups. All of these solutions proved difficult to maintain, support and keep up-to-date over time; and, inevitably, these technologies fell behind.

		Not until the advent of cloud technology was there a feasible way to implement a global single source of truth. The flexibility of the cloud allows applications to be scaled, updated and changed as needed with business and regulatory requirements. Companies are freed from the burden of maintaining and updating multiple software environments—a multitenant cloud architecture means the application itself delivers a constant stream of innovation, painlessly. All departments are upgraded at once, so no one team is held up. And, because the cloud is easily and securely accessible through a simple web login worldwide, it can serve as the single source of documents for all users&mdash;regardless of location&mdash;without the need for dedicated private networks, or use of the traditional, laborious file transfer protocol (FTP). Internal and external stakeholders can come together in real time, eliminating information siloes and enabling full collaboration and visibility.

		Historically though, life sciences companies were largely unable to use generic cloud applications that had not been built to accommodate the industry’s specific regulatory requirements. New cloud applications, designed specifically to address the need for controlled content across the enterprise, are now available—representing a major shift. Gens & Associates 2015 RIM survey, in fact, shows these cloud-based solutions are gaining significant traction across the global life sciences market. [3]

Next-generation cloud for enterprise-wide collaboration

		Veeva Systems recently launched the next wave of life sciences content-management applications, combining a robust cloud-based content platform with best-of-breed applications for each distinct business process. For the first time, individual documents created in one application can be used across different business processes—whether in a submission, TMF or promotion. Past attempts to link documents did not allow different groups to manage documents within their own context. Veeva Vault’s contextual links make documents easier to create, organize and access for different users&mdash;and all content is traceable throughout its lifecycle, enabling a controlled source of truth regardless of where and how the document is used.

		With a single source of truth, process complexity is now drastically reduced. Remember the example of the protocol process? In a single-source environment, those 20+ steps can be reduced by more than 50%, saving precious time. The protocol may be authored by the medical writer, incorporated into a clinical trial master file, distributed to investigator sites, used in a clinical study report, incorporated into a submission, and ultimately referenced by a promotional claim without ever creating a copy of that content—saving time while increasing control. A simple chain of custody connects clear contextual audit trails, allowing users to see the impact of content changes in real time.

		Rapidly growing Kythera Biopharma-ceuticals, needing to accelerate the development of its newest product candidate, turned to the cloud to connect its document repositories globally across functional areas. The company selected an end-to-end regulated content management platform, in the cloud, that includes a family of business-specific applications that allow Kythera to easily connect work streams across the organization.

		“We looked for an enterprise-wide solution that could effectively serve diverse masters across the business—regulatory, CMC, clinical, sales, marketing, HR, finance and legal&mdash;with different requirements for user knowledge, compliance and security,” says Jeff Webster, Kythera’s former senior vice president of operations. “Today, we have a foundation that brings together the entire organization.”

		In addition to connecting Kythera’s teams, the new system’s cloud architecture allows the organization to focus on its core business (developing therapies for facial aesthetics) and not spend time managing hardware and software upgrade projects. “We needed a cloud environment,” explains Renee Fate, senior manager of document management at Kythera. “We no longer have to manage servers; updates are pushed out automatically without disrupting our teams; and our mobile workforce can access the system from anywhere in the globe, with any device.”

		Kythera is moving toward deepening their content management capabilities by enabling the cross-linking of documents across applications. Fate describes the value of creating a document once and using it in multiple instances, “Connecting content processes enables an unprecedented level of business agility, and helps us get to market faster. Without ever physically moving a document, this technology allows us to share information seamlessly with everyone involved—from internal groups to external partners across the ecosystem&mdash;without sacrificing security or agility.”

		These benefits span beyond the development process into product launch and commercialization. For instance, with a single source of truth, regional brand teams can leverage assets from corporate in new product packaging, certain the information is up-to-date without wasting time tracking down or re-entering the same details. Document reuse is extended for medical, marketing and sales teams for websites, self-directed digital details, email, mobile, and even face-to-face interactions between field sales reps and healthcare professionals. Connected content can be shared between business applications, while each functional team can manage the documents according to their specific needs.

		Traditionally, life sciences companies have had to choose between an inflexible centralized repository that supported content sharing and corporate control, but added enormous complexity in governance and operations—versus decentralized solutions that meet local or departmental requirements, but limit content reuse and tracking. Either efficiency or progress was compromised since there was no ability to address process, efficiency and compliance across the board. Today’s cloud-based content management solutions change that landscape, providing a single source of the truth, while streamlining governance and reducing overall complexity.  

Tufts Center for the Study of Drug Development, “Drug Sponsors Challenged to Contain Health Care Costs while Boosting Productivity,” January 8, 2015. For more: http://csdd.tufts.edu/news/complete_story/pr_outlook_2015

Forbes Magazine, “The Cost of Creating A New Drug Now at $5 Billion, Pushing Big Pharma To Change,” by Matthew Herper, August 11, 2013. For more: http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/

Gens & Associates, “2015 Next Generation RIM & Intelligence: Strategy, Investments, Status,” by Steve Gens and Greg Brolund, January 2015. For more: http://gens-associates.com/wordpress/wp-content/uploads/2015/01/Executive_RIM_Whitepaper_Gens_Associates_Winter-2015_Edition.pdf

Clinical Leader, “Technology Trends Will Impact Clinical Trials In 2015,” By Ed Miseta, November 21, 2014. For More: http://www.Clinicalleader.Com/Doc/Technology-Trends-Will-Impact-Clinical-Trials-In-0001?Sectioncode=Articles&Templatecode=Single&User=3058369&Source=Nl:41975&Utm_Source=Et_6212879&Utm_Medium=Email&Utm_Campaign=Clncl_2014-12-17&Utm_Term=Cc3f2b3d-2115-496a-A070-7f7c816e8238&Utm_Content=Technology%2btrends%2bwill%2bimpact%2bclinical%2btrials%2bin%2b2015

		Jennifer Goldsmith is the VP of Vault Strategy at Veeva. She has honed her skills for regulated content management over the last 20 years by working with clients such as Johnson and Johnson, Pfizer, Shire, BMS, Roche; and with industry leaders such as IBM and CSC. Prior to joining Veeva, Jennifer was a leader in IBM’s Life Sciences Global Business Services Practice, where she was responsible for managing a global consulting team focused on life sciences technology innovation and implementation. Jennifer graduated with honors from Cornell University, with a B.A. in psychology.

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