Will Technology Adoption Change Your Partnering Strategy?

By Ed Miseta, Chief Editor, Clinical Leader

To better understand the issues presented by lagging technology adoption, Veeva Systems undertook the largest-ever survey of trial master file users. The effort, titled Veeva 2014 Paperless TMF Survey: An Industry Benchmark, examined 252 TMF owners. Among other things, the report found a majority of users were still using paper or electronic file systems to manage their TMF. The survey also found companies using advanced eTMF technologies, including content management systems and purpose-built eTMF applications, experienced greater inspection readiness, visibility, SOP compliance, and cost savings than those using local or cloud file systems.

I took this opportunity to speak with Jennifer Goldsmith, VP of Vault for Veeva Systems, to determine what the findings mean for pharma companies, CROs, partnering strategies, and what the industry can do to speed up the adoption of new technologies to enhance clinical trials.   

Ed Miseta: What does this survey mean to pharma companies doing clinical work?

Jennifer Goldsmith: Veeva’s 2014 Paperless TMF Benchmarking survey is the largest TMF survey to date and takes a different approach by looking more closely at the type of TMF processes and systems that life sciences companies and CROs are using today. This in-depth study of about 300 TMF owners uncovers interesting findings not revealed in other surveys such as the fact that a majority still use paper or electronic file systems to manage their TMFs. Further, we found that the type of electronic system has a significant impact and that those with eTMF applications and content management systems achieve the greatest number of benefits including better visibility into key trial performance metrics, easier collaboration with CROs, improved inspection readiness, SOP compliance, and cost savings. Pharmaceutical companies that capture metrics using their eTMFs, even rudimentary data, also impact the level of benefits gained. I believe this says three things to pharmaceutical companies:

1. Going paperless is beneficial;

2. Moving to an eTMF application or content management system – as opposed to just a basic online file share – will provide even greater benefits; and,

3. Building metrics into your process/system from the outset will help achieve a greater level of benefit.

Miseta: Will these results have an impact on a company’s outsourcing strategy and its partner selection process?

Jennifer Goldsmith, vice president of Vault, Veeva Systems

Goldsmith: The findings from our 2014 Paperless eTMF survey should and will encourage sponsors seek out partners like CROs that have invested in more advanced eTMF capabilities, such as an eTMF application rather than those still reliant on paper-based processes and file systems. It may also mean that more life sciences companies will expect their CRO partners to leverage their own internal eTMF systems if they do not have strong eTMF capabilities or cannot externalize those capabilities for direct access to the sponsoring organization. I also believe that this will push sponsors to work more strategically with partners to develop common metrics so that, together, CROs and their sponsors can maximize their eTMF capabilities and ultimately improve trial processes.

Miseta: What do the results say about the future of eTMF, its growth trend, and adoption of the technology?

Goldsmith: The survey results suggest that in order to drive greater benefits, simply making content ‘electronic’ is not enough. Maintaining the same old paper processes but using email or file shares is not enough. To stay competitive and to meet the audit expectations of health authorities globally, organizations will rapidly adopt eTMF applications in the same way that organizations moved from paper CRFs to EDC. The growth trend here is tremendous. In fact, we anticipate a large percentage of TMF owners to migrate to eTMF applications over the next six to 12 months.

When the results of this survey started coming in, we were shocked at the low level of technology maturity with TMFs…but it’s the reality the industry faces. Why? In many cases, this is because of some of the perceived barriers associated with adopting eTMF technology. Today, however, those barriers are nearly gone. For example, the perception that wet ink signatures are required is not true. In fact, there is no specific regulation that requires documents to have a wet ink signature; electronic or digital signatures are acceptable for TMF documents. Additionally, one of the most commonly cited barriers is cost – again a non-issue today. New technology models have brought the costs of implementation and ongoing maintenance down dramatically, making world-class eTMF capabilities affordable to even the smallest companies. With cloud-based applications, for instance, organizations pay for only what they use, which means they can easily and economically adopt eTMF technology. There are no significant up-front costs, such as hardware, operating system, and database licenses. 

Miseta: Is there anything that can be done to speed up eTMF adoption?

Goldsmith: There are already many things in play that will help to speed eTMF application adoption. The DIA eTMF Reference Model is one key driver. By providing a common nomenclature for discussing and sharing clinical content, the Reference Model is already speeding eTMF adoption and facilitating communication between organizations, such as sponsors, CROs and sites. In addition, the availability of eTMF-specific software solutions is assisting in this adoption process. By providing core eTMF capabilities out of the box and thereby shortening implementation times and time to value, as well as decreasing overall costs, eTMF-specific software solutions are helping to speed the adoption of eTMF across the life sciences industry.

Jennifer Goldsmith, vice president of Vault at Veeva Systems, is a pioneering thinker with a long history of leadership in life sciences and technology. Goldsmith 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. Following the launch of Vault in 2011, PharmaVOICE named Goldsmith one of the Top 100 Most Inspirational Leaders in life sciences.