Veeva 2015 Paperless TMF Survey: Annual CRO Report

Transcription

1 Veeva 2015 Paperless TMF Survey: Annual CRO Report The Veeva 2015 Paperless TMF Survey: Annual CRO Report explores the progress made by contract research organizations (CROs) toward paperless clinical trials through the experiences and opinions of CRO Trial Master File (TMF) owners from around the globe. The responses in this report were collected as part of the larger industry-wide Veeva 2015 Paperless TMF Survey: Annual Report. The goal of this research is to understand the impact of growing etmf adoption on CROs as well as the drivers, benefits, and barriers to going paperless. Building off of the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs, which showed lagging technology adoption and a prevalence of paper in clinical processes, the 2015 survey examines whether CROs have reduced paper documents and improved TMF processes. Key Findings More than one-third (38%) of CROs surveyed now report using an etmf application versus 21% in More than half (58%) of respondents report speeding study start-up as the greatest driver for etmf adoption, followed by cost savings (50%). CROs are reducing the amount of TMF documents managed on paper, with significant declines reported in clinical operations, regulatory, safety, and data management departments. As compared to 2014, greater numbers of CROs now exchange TMF documents with sponsors via etmf applications (36% today, up from 24%), and are much less reliant on paper (46%, down from 65%). Two-thirds (66%) of respondents report they are electronically archiving documents, and more than half (52%) are conducting remote document review. CROs report etmfs improve TMF quality and inspection-readiness across all inspection categories. Veeva 2015 Paperless TMF Survey: Annual CRO Report 1

2 Types of Electronic Trial Master Files and Drivers of Adoption Respondents were asked which type of etmf solution do they use, and findings reveal increases in etmf application usage. More than one-third (38%) of CRO respondents now use an etmf application versus 21% in An etmf application is typically built on a content management platform and provides functionality and configurations specific to TMF documents, along with process-driven content management functionality such as workflow, automation, and reporting. Local file systems provide access to a shared folder structure and online storage. Cloud file shares provide additional capabilities, the most important of which is easy access for external parties. Approximately, one in five (21%) respondents report using a content management system (CMS), down 12 percentage points from The use of a file share, whether a local file system or a cloud file share remained about equal. etmf System Currently in Use Base 2015: Total respondents, N = 42 Base 2014: Total respondents, N = 43 Content management system 21% File share 21% Content management system File share 21% etmf application 38% Local file system 19% etmf application 21% Local file system 26% What type of etmf solution do you currently use? Select only one. (Q.9) Speeding study start-up (58%) is the most frequently cited motivating factor for CROs to adopt etmfs. Study start-up is a document-intensive process reliant upon external collaboration and is integral to meeting key study deadlines. Half report that cost savings (50%) and improved audit/inspection readiness (46%) are also top drivers of etmf adoption. Better visibility into performance metrics is seen by 44% of respondents as a key, influencing factor. Veeva 2015 Paperless TMF Survey: Annual CRO Report 2

3 Top Drivers of etmf Adoption Speed study start-up Cost savings Improved audit/inspection readiness Better visibility into performance metrics Improved monitoring Easier collaboration 50% 46% 44% 42% 38% 58% Which of the following business benefits are the most important in motivating your organization s adoption of etmfs? Please select the top three benefits. (Q.7) Consistent with the viewpoint that study start-up is a primary motivating factor for etmf adoption, two-thirds (66%) of CROs surveyed claim if the study start-up process were managed in an etmf it would shorten development time. Almost three-quarters (72%) say managing TMF filing in an etmf would shorten development time. Inspection preparation (52%) is also cited by more than half of respondents as a process that could quicken development times if managed in an etmf. Would Shorten Development Time if Managed in an etmf TMF filing 72% Study/site start-up 66% Inspection preparation 52% Remote monitoring Audit response Country/site feasibility 32% 30% 28% Study planning & protocol authoring 22% Drug accountability 12% In your opinion, which of the following processes would significantly shorten clinical development time if they were managed with an etmf? Select up to four processes. (Q.6) Most CROs surveyed do not see significant barriers to TMFs going paperless. Thirty-nine percent of respondents cite cost of technology and implementation services as a significant barrier to TMFs going paperless. This is in contrast to the 50% of CRO respondents that cite cost savings as a driver of etmf adoption in their organization. Veeva 2015 Paperless TMF Survey: Annual CRO Report 3

4 Regulatory requirements () and limitation of in-house tools and technologies () are the next highest hurdles. Significant Barriers to TMFs Going Paperless Cost of technology/implementation services Regulatory requirements Limitation in-house tools/technologies 39% Lack of internal support/knowledge 27% Impact of organizational change Lack of interest/priority 11% 21% To what extent is each of the following a barrier to TMFs going paperless in your organization? (Q.4) Use of Paper and Benefits of Electronic Processes Respondents estimated the extent to which different departments manage TMF documents on paper at any time during a document s lifecycle. There were double-digit reductions reported in the number of TMF documents managed on paper within clinical operations (34%), regulatory (31%), drug safety (20%), and data management (8%). The data management area saw the largest decline in the use of paper (down 19 percentage points). However, also notable is the 13-point percentage drop in the use of paper by clinical operations, since it is the area that generates the majority of documents in the TMF. Percent with Most or All Documents Managed on Paper at Some Point Base 2015: Total respondents, N = 50 Base 2014: Total respondents, N = 43 Clinical operations Regulatory 31% 34% 47% 46% Drug safety 20% 37% Data management 8% 27% In each area, how many of your company s TMF documents are managed on paper at any point in their lifecycle? (Q.3) Veeva 2015 Paperless TMF Survey: Annual CRO Report 4

5 (68%) and paper (46%) remain the dominant method of exchanging TMF documents between sponsors and CROs. However, CROs report substantial declines in the use of (80% in 2014) and paper (65% in 2014) as exchange methods. The results indicate that CROs are also less reliant on portals and fax to exchange TMF documents and are increasing their use of etmf applications and CMS. In 2014, a quarter (24%) of CROs surveyed said they exchanged documents with sponsors using an etmf application; that number has increased to one in three (36%) today. The use of CMS applications to exchange TMF documents with sponsors is also up from in 2014 to 42% in Methods for Exchanging TMF Documents between Sponsors and CROs Base 2015: Total respondents, N = 50 Base 2014: Total respondents, N = % 80% Paper shipments 46% 65% Portal 42% 57% Fax Cloud file share 16% 35% 35% etmf application 24% 36% Content management system 42% What methods does your team use to exchange TMF documents with external parties? (Q.2) Respondents indicated which TMF processes their organization currently conducts electronically. Two-thirds (66%) of CROs report they electronically archive TMF documents and half (52%) conduct remote document review. However, only one in five (20%) CROs report they are using e-signature and just a quarter (24%) report they create source documents electronically. Electronic signature is also the capability CROs cite most often (54%) as missing, but required for their organization to go paperless. The FDA and MHRA have reduced signatory requirements to a handful of documents and have instituted broad acceptance of electronic signature. Veeva 2015 Paperless TMF Survey: Annual CRO Report 5

6 Mostly or Always Doing Electronically Electronic archival 66% Electronic document review 52% Electronic external collaboration 42% Electronic source document creation Electronic signature 20% 24% To what extent is your company currently doing the following [electronically] with TMF documents? (Q.8) Capability Required, but Missing Digital or e-signatures 54% Integration with CTMS 46% Integration with EDC 40% Secure access by external parties Tracking and reporting Electronic forms Archival and export capabilities 36% 34% 32% 30% System compliance with 21 CFR 11 26% Which capability(ies) listed is your organization currently missing and would be required by your organization in order to move to paperless TMFs? Select all that apply. (Q.5) Veeva 2015 Paperless TMF Survey: Annual CRO Report 6

7 Use of Metrics Respondents were asked to what extent their organization collects and uses TMF operational data, and the overall response shows the use of TMF data today is low. Less than half (40%) of CROs are leveraging TMF data to improve trial processes in some cases, and only 16% are using metrics extensively to improve trial processes. Organizations Collecting TMF Metrics Base: Total respondents, N = 43 Extensively using TMF data 16% Not collecting TMF data 12% Using TMF data in some cases 40% Rarely using TMF data To what extent is your organization leveraging TMF operational data (e.g., time from initial review to approval) to improve trial processes? (Q.13) When asked to choose which were the most useful metrics to shorten trial time from a list of eight, those associated with study start-up led the way. More than two-thirds of CROs assert that access to information about the cycle time from site selection to institutional review board (IRB) approval (70%) and the time to collect essential site documents (68%) are the most important metrics. Veeva 2015 Paperless TMF Survey: Annual CRO Report 7

8 Most Useful Metrics to Shorten Trial Time Site selection to IRB/IEC approval Collect essential site documents 70% 68% TMF quality check 54% Site identification to site selection 48% Ethics committee or regulatory authority application 38% Planned vs actual subject enrollments 32% Number of protocol amendments Internal study approval to final protocol 26% 26% Which of the following metrics are, or would be, the most useful in your efforts to shorten clinical trials? Please select up to five most useful metrics. (Q.14) Reported Benefits of an etmf Respondents were asked to indicate which, if any, benefits they experience with the use of an etmf. Two-thirds (67%) of CROs using an etmf report it is easier to search and find documents, and 57% report improved audit and inspection readiness. Automated tracking and reporting of documents (43%), easier external collaboration (40%), and better visibility into performance metrics (40%) also ranked as top benefits accrued with the implementation of an etmf. Benefits Attributed to an etmf Base: Total respondents, N = 42 Easier to search and find documents 67% Improved audit and inspection readiness 57% Automated tracking/reporting of documents Easier external collaboration Better visibility into performance metrics Improved central/remote monitoring Cost savings 43% 40% 40% 36% Faster study start-up 19% What benefits were achieved with your organization s implementation of the etmf solution specified in Question 9? Select all that apply. (Q.10) Veeva 2015 Paperless TMF Survey: Annual CRO Report 8

9 Improvements in Inspection Areas The use of etmfs improves TMF quality across all inspection areas. CROs who use etmfs overwhelmingly indicate improvements in eliminating missing documents (92%), misfiled documents (89%), duplicate documents (86%), incomplete documents and missing signature (84%), and expired documents (81%). Improvements in Inspection Area Base: Total respondents, N = 42 Missing documents Misfiled documents Duplicate documents Incomplete documents and missing signature Expired documents 92% 89% 86% 84% 81% How much improvement, if any, did you observe in the following inspection areas after your organization implemented the etmf solution specified in Question 9? (Q.11) Conclusion Over the last year, CROs have made significant strides in driving toward the paperless trial. The use of advanced etmf applications among CROs has almost doubled, and CROs are reducing the amount of TMF documents managed on paper. The large drop in the use of paper in clinical operations is particularly encouraging. These moves will allow CROs to provide greater levels of service to sponsors. Despite these positive indicators there are still areas for continued improvement. and paper, while declining in use, remain the most prevalent methods of document exchange with sponsors. While is electronic, it is still a largely unstructured form of communication that is difficult to track and audit. CROs are embracing some electronic processes, including electronic archive and remote document review. However, others have yet to gain traction and hinder efforts to remove paper from TMF processes. Only a fifth of CRO respondents, for example, report using electronic signature to sign documents, despite broad acceptance by health authorities. Collection and usage of metrics to improve trial processes is another area for improvement. The number of CROs fully leveraging metrics to improve trial design and execution is low. Organizations that leverage metrics more extensively achieve greater benefits from their etmf according to data from the industry-wide Veeva 2015 Paperless TMF Survey: Annual Report. Veeva 2015 Paperless TMF Survey: Annual CRO Report 9

10 Adopting paperless processes and advanced etmf technology allows CROs to align themselves with the growing expectations of study sponsors and give them an advantage in a competitive marketplace. CROs have been a driving force for industry-change over the past year as they look to create a fully integrated, electronic TMF operating model. Survey Methods The survey consisted of 13 questions, many of which included sub-questions with response matrices. Survey questions were designed for individuals with knowledge of TMF document processes and with full or shared responsibility for a TMF within their organization. The survey was commissioned by Veeva systems and conducted by Fierce Markets. Completion of the survey was voluntary, and the first 50 respondents were offered a $5 gift card. All respondents were offered a summary of the survey results. No other compensation was offered or provided. Survey Respondents Of the more than 200,000 individuals invited to take the survey, a total of 2,278 surveys were initiated, the majority of which were terminated based on a qualification question gauging the level of responsibility for a TMF in their organization. More than 175 unverified responses were eliminated, yielding 50 qualified survey responses from CRO organizations. Contact For more information about this study, please contact us at etmfsurvey@veeva.com. Copyright 2015 Veeva Systems. All rights reserved. Veeva and the Veeva logo are registered trademarks of Veeva Systems. Veeva Systems owns other registered and unregistered trademarks. Other names used herein may be trademarks of their respective owners. Learn more at veeva.com info@veeva.com