Tomorrow s Trials: Perceived Barriers to Going Paperless Crumble in the Cloud

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1 Tomorrow s Trials: Perceived Barriers to Going Paperless Crumble in the Cloud Jennifer Goldsmith, Vice President, Veeva Vault, Veeva Systems one in 10 respondents (13%) are already leveraging purpose-built etmf applications that include process-driven workflows and capabilities for managing trial documents and data electronically. Further, the number of TMF owners actively building or evaluating etmf applications to support efficient collaboration throughout a clinical trial study is up from 17% in 2010 to 33.6% today, according to a 2014 DIA TMF Reference Model survey. The recently published Veeva 2014 Paperless TMF Survey: An Industry Benchmark examined the current state of electronic Trial Master File (etmf) adoption as well as the benefits, drivers and barriers to implementing electronic processes. This in-depth study of more than 250 TMF owners showed that etmfs deliver deep operational efficiencies and high TMF quality. Additionally, those using advanced etmf technologies reported experiencing greater inspection readiness, visibility and standard operating procedure (SOP) compliance as well as cost savings compared to those using local file systems or simple cloud file shares. As regulatory and competitive pressures quickly mount, more life sciences companies are on the cusp of evolving from what have been largely manual TMF processes and simple file shares or paper towards new, advanced etmf technologies to enable paperless trials. In fact, This growing digital movement suggests that historical barriers to going paperless are diminishing. In the 2014 Veeva Paperless TMF Survey, only one major barrier emerged among a majority of TMF owners concern over being able to grant secure access (62%). Cost, the next-ranking barrier, was cited by a minority of respondents, who noted concerns with the costs of technology (38%) and implementation (33%), while less than one-third indicated concern over regulatory requirements for wet signatures (28%). Let s take a closer look at each perceived barrier. Regulatory Barriers Demystified Historically, life sciences companies believed that health authorities requirements for wet signatures would hinder the use of electronic systems for their TMFs. However, today, health authorities broadly accept the use of electronic or digital signatures and in many instances no longer require signatures at all. As far back as 2003, the US FDA had stated in 21 CFR 11, This

2 regulation [21 CFR 11], which applies to all FDA program areas, was intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health. In fact, no major health authority globally mandates wet ink signatures on TMF documents anymore; all accept signatures electronically when they are required. Despite industry perceptions, today there are a very limited set of documents requiring signatures as indicated by ICH GCP Section 8. Most other documents in the TMF do not require signatures, with workflow approval documented in audit trails used in their place, remarked Lisa Mulcahy, owner and principal consultant of Mulcahy Consulting, LLC and cochair of the TMF Reference Model (TMF RM) Team, the group of volunteers that created and maintains the TMF RM. Fig 1: TMF Signature Requirements TMF Content Requiring Signatures per ICH Guidelines Kythera, a clinical-stage biopharmaceutical company with a forward-looking TMF strategy, bears out Mulcahy s interpretation. The company adopted a cloud-based etmf application to manage its TMF and is now able to capture electronic signatures as a result. Kythera has done away with wet ink signatures on essential documents complete. Historically, we collected many more signatures than the government requires, adding inefficiency to the process, noted Renee Fate, Kythera s senior manager of document management. Kythera is not alone. Many life sciences companies waste time chasing people for wet signatures, often on documents that do not require a signature. Many companies with an etmf unnecessarily deliver, sign, and scan documents steps no longer needed with most etmf applications. There are many steps that can be eliminated entirely by moving to a fully electronic process, as shown in Figure 2. Figure 2: Clinical Trial Agreement Process Current Practices versus etmf Application Protocol signature page (Sponsor and Investigator) Agreements Signature Sheet (ex. Site Delegation & Signature Log) Completed Case Report Forms Regulatory Required Forms, if required (ex. Form FDA 1572) Subject Informed Consent Forms

3 Today, robust purpose-built etmf applications typically include e-signature capabilities that meet 21 CFR 11 requirements, making it easy to collect electronic signatures where needed, without regulatory concern. And as Veeva s research shows, 66% of survey respondents indicated that their organization needs e- signature capabilities to go paperless; the barrier here may not just be concern over regulatory requirements but rather, a lack of adoption of necessary technology. Shedding Light on Costs of Electronic Applications Despite industry s concern about the costs of transitioning to electronic applications, costs can go down with cloud etmf applications. Before the current generation of etmf applications, many life sciences companies built custom software on top of existing on-premise platforms in order to manage TMF content. These required huge financial investments, and as such, companies continue to leverage these systems today, despite their aging capabilities. Paradoxically, this line item contributes to perceived cost barriers in adopting modern etmf applications. Today, purpose-built etmf applications are designed with applicable functionality built in for use right off the shelf with only minor configuration, eliminating the expense associated with custom design. Multitenant etmf applications in the cloud can deliver even more cost savings because a company pays only for what it needs without the intimidating upfront cost of traditional systems. With true cloud applications, there is no infrastructure to purchase, install or maintain: The provider manages the software, and all updates are delivered automatically behind the scenes with little to no disruption to users. This ensures that users are always working on current technology, and eliminates the massive expense of updates. Implementation costs of cloud etmf applications also plummet in comparison to onpremise or hybrid systems. According to Forrester, the implementation costs for an onpremise system are typically one to five times the total software license cost; whereas the implementation costs for applications in the cloud are often one time or less of the first year subscription fee. Because these implementation costs are so low, even the smallest biotech can afford cutting-edge etmfs something unimaginable just five years ago when systems were still predominantly on-premise. Implementation in the cloud is also easier and fidelity to real user requirements is much higher, saving additional time and money. Contributors can oversee the configuration as it happens, so the application can be tested and changes can be made during implementation not after. The baseline application can be provisioned quickly, so users can start on day one. All told, a multitenant cloud system can be implemented in weeks in contrast to traditional technologies that six or more months of laborintense programming. In the cloud, companies can set up an etmf immediately for each new study anywhere in the world. Plus, TMF managers can add new sites and users in minutes, making it fast and inexpensive to add new sites wherever their location, and to incorporate all parties into the workflow. Interestingly, despite the fact that 38% of respondents in the Veeva survey see cost as a significant barrier to going paperless, an equal number see cost savings as a significant benefit of their etmf. This tension seems to imply the industry is still in a learning mode regarding

4 cloud technology, with early adopters already reaping benefits. According to a report published by Nucleus Research, companies continue to invest in cloud applications because of low upfront cost and faster time to deployment, but those are not the only reasons to move to the cloud. Beyond their initial payback, cloud applications deliver 1.7 times more ROI than on-premise software. Straight Line to Secure Access The growing number of trial stakeholders (CROs, sites, agencies, committees and even patients) has dramatically increased the complexity of assembling the numerous TMF documents into a coherent package. So it is no surprise that Veeva s benchmarking survey reports that 62% of TMF owners say they need secure access for external parties in order to go paperless. This is another barrier that seems to be simply a matter of perception. Modern cloud technologies can provide secure system access, enabling all parties in the study to collaborate efficiently. Gone are the challenges of distributing laptops, accessing a virtual private network, and trying to circumvent the organization s information security policies or getting around a corporate firewall. Cloud etmf systems allow all approved collaborators to access clinical trial documents in real time with a single, secure log-in. This permits document exchange on demand, wherever authorized users can access the web (see Figure 2). Sponsors, CROs and site personnel can quickly access a cloud etmf from any device anywhere in the world, make necessary changes to documents, and then save them back to the central repository in the cloud for an up-to-date, single source of the truth. The cloud also provides convenient access to health authority auditors, who are increasingly seeking electronic access to the TMF. Most recently, the United Kingdom s Medicines and Healthcare Products Regulatory Agency (MHRA), has tightened its regulations to include ready TMF accessibility a difficult objective to meet using a local paper-based TMF system. Universal accessibility also greatly improves inspection readiness, another regulatory and study cost concern. Eldin Rammell, a clinical records management expert and managing director at Rammell Consulting, said, In the face of MHRA s updated definition for critical findings, it is encouraging that organizations utilizing etmf applications are experiencing significant benefits in inspection readiness and business efficiency gains. Linda Danielson, COO of IDDI, a specialty CRO, added, Audit prep can go from many weeks to just a couple of hours with a cloud-based system. Inherent Value in Going Paperless A purpose-built etmf application delivers value to organizations that paper simply cannot a TMF that is inspection-ready at all times, a focal point for sponsor-cro collaboration, and visibility into operational performance that spans the entire clinical organization and its partners. Ideally, it is designed to drive integrated processes between all parties. The cloud enables many benefits, particularly in the context of the global footprint that marks today s clinical studies. Veeva survey respondents utilizing more mature technologies, specifically process-driven etmf applications and content management systems, agree. For example, 81% of those with a process-driven etmf application indicate higher TMF quality and reported good or major

5 improvement in misfiled documents compared to 62% of local file system users. Another 47% realize cost savings, as compared to only 29% using a local file system. Greater inspection readiness, visibility and SOP compliance as a result of using advanced etmf applications were also noted. IDDI hasn t looked back since it transitioned to a cloud-based, purpose-built etmf application. We were looking to move from our hybrid system part paper and part online file-share to a single, digital solution for TMF management to improve quality, efficiency, and control while allowing our colleagues and clients to access our data through the cloud, said Danielson. Another CRO, Advanced Clinical, also recently went paperless. A cloud-based etmf gives us and our clients a strategic advantage, said Julie Ross, executive vice president at Advanced Clinical. We can speed document collection from start-up through trial close, and our clients get the visibility they need throughout the entire study. Organizations that have already leveraged purpose-built etmfs are enjoying a bevy of advantages over their peers, from improved operational efficiency to an always inspectionready etmf. The barriers that once held life sciences companies back have been debunked, making way for progress. It s time to concede the facts, move boldly past yesterday s reservations and seize the modern day with cloud technologies built for today s challenges. About the Author Jennifer Goldsmith, Vice President of Vault at Veeva Systems, spearheaded the development of the first cloud-based regulated content management solution for the life sciences, the Vault product line. Goldsmith oversaw the vision, implementation and marketing of Vault; Vault s industry cloud applications for regulated content management have received widespread acclaim for combining a focus on supporting regulatory compliance with the flexibility of cloud computing. Following the 2011 Vault launch, PharmaVOICE named Goldsmith one of the Top 100 Most Inspirational Leaders in life sciences. Goldsmith has been active in the life sciences sphere for more than 15 years, working across the value chain from early R&D to commercial operations. As a life sciences services leader for IBM, where she received the IBM Services Excellence Award for five consecutive years, she brought her expertise to bear on projects for some of the largest life sciences companies in the world. Jennifer earned her BA in Psychology from Cornell (NY) University, and completed continuing study at the University of Nottingham (UK) in conjunction with her degree program. References available upon request.