In the drug development world, training and standardization around the role of the Clinical Research Associate (CRA) has always been a business critical function for all CROs and their bio/pharma customers. As CRAs function largely in the role of auditor and support in ensuring that experimental medicines are closely monitored for safety and efficacy in the population they are designed for, it is crucial that these staff approach their responsibilities with a consistent process methodology to maximize oversight and monitoring of a clinical trial. Most often these personnel are gathered in a central location where they receive extensive onboarding and instruction on their role and responsibilities. In more broad-based and less intensive programs, CRAs are provided information via webinars or teleconferences with accompanying printed material for reference.

The training and standardized methodology is instituted in an effort to both meet the customer’s expectations for quality deliverables and to service the recommendations of the FDA around staff that are adequately trained to function in this role on a clinical research trial. Careful records and documentation regarding this training are collected to ensure appropriate support in an audit situation. There is an additional aspect to this thorough training. Equal provision of information and instruction allows those with direction over clinical trials to standardize expectations around performance and improve employee evaluations. Providing this intensive initial training along with the ongoing assessments of performance in the traditional manner means that the methodology used to on-board and train a globally deployed staff of clinical researchers is not sustainable for the future, either financially or logistically.

It is common for large CROs to have a globally deployed staff of CRAs located in many different countries and all regions of the world. The value of regional staff leads to cost control in the form of reduced travel and also supports a robust knowledge base around local rules, regulations and cultural norms. The CRAs allocated to a clinical trial team are often a mixture of office-based and home-based staff. With the advent of mobile technology and the variety of communication and collaboration tools, staff are no longer confined to a centralized workspace and many are remote workers who are home-based (while spending a large percentage of their time on the road). Global Workplace Analytics and the Telework Research Network state that the growth in multiple days per week employees (not including self-employed) telecommute increased 73% from 2005 to 2011. Further, their research shows that if those with compatible jobs and a desire to work from home did so just half the time, the national savings would total more than $700 billion a year:

• A typical business would save $11,000 per person per year
• The telecommuters would save between $2,000 and $7,000 a year
• The oil savings would equate to more than 37% of our Persian Gulf imports
• The greenhouse gas reduction would be the equivalent of taking the entire New York State workforce permanently off the road

In the 2008 list of Fortune 100 Best Companies to Work For, 84 out of the top 100 firms allowed their employees to telecommute or work at home at least 20% of the time. While supporting a regional workforce seems standard protocol these days and is facilitated by technology allowing us anytime/any-where connections, it is still vitally important that the way we support, train, and collaborate with our workforce maintains the same effectiveness and provides the same quality as more traditional methodologies, such as face to face meetings. Equally important is how we pay attention to the age diversity of the workforce in regard to technological capabilities and proficiency with the alternative devices and software available today. Technological innovation and new developments are,in essence, progressing at the speed of light; with that comes facilitation of the delivery of skill development and performance enhancements through that technology. Add to this mix the need for equipment evaluation, standardization and governance, security, employee connectivity, training for the trainers, and maintenance and it becomes evident that it could be a daunting task to visualize alternatives to traditional training delivery.

Although working out alternatives to traditional training methodologies can be overwhelming, it is recognized that the current face-to-face training methodology most companies have in place to onboard clinical research associates is not sustainable, and in some cases, no longer innovative. Learning and technology teams can focus collaboratively on evolving their training to drive greater employee engagement and collaboration in a better learning experience. With the ongoing popularity of social media and role-play gaming, the exploration of how to leverage such interactive, collaborative tools in a corporate environment is intriguing. It is possible to adapt the traditional classroom training program for the virtual-world environment and deploy it across one’s company globally to improve the cost-effectiveness, speed and quality of training researchers who oversee clinical trials of new medical treatments.

While traditional classroom training programs have been highly acclaimed and effective, innovative development teams focused on evolving their training to drive greater employee engagement and collaboration in a better learning experience can be successful as well. By deploying industry-leading technology, innovative teams can further differentiate themselves from their competitors to client stakeholders, employees and new recruits. Collaboration with existing providers of virtual world media is possible and in many cases provides a jumpstart on the conversion of face-to-face training. Using personalized avatars in a virtual space, clinical research team members can meet remotely with each other and clients while engaging in highly social, interactive and visually appealing 3-D virtual spaces. Users can talk, send instant messages, view and interact with presentation and media content, record notes and access the Web — all at the same time, from anywhere around the globe. The learners might collaborate to solve a problem, accomplish a task or overcome a challenge. Use of this technology is facilitated by the everyday use of similar tools by an engaged and modernized workforce. An interactive virtual tool offers options not readily available in face-to-face training, such as material persistence. Having the opportunity to return to the classroom in any time zone at any moment for training material from the day’s lessons and conferences means more time to pay attention in class and additional opportunities to review and assimilate information provided in training and collaborative sessions. Instant messaging allows participants to invite colleagues to join at the meeting scene, providing mentoring and idea sharing not possible face to face.

A notable challenge in moving to a virtual training platform lies in the conversion of existing materials designed for in-person interactive audiences in a bricks-and-mortar workplace into a format that is as effective and takes full advantage of the capabilities provided in a virtual space. To do this successfully requires a skilled team of learning specialists who understand and can imagine the difference between what’s possible and what doesn’t translate well between the alternative methodologies to support effective training. The training will ideally include both synchronous and asynchronous components and allow flexibility on behalf of the participants to complete some portions of the training within a flexible time schedule. Different workspaces can be used for collaborative group sessions, strategy and best practice discussions, classroom information delivery, role playing and ongoing, periodic evaluation. Social hours and “meet and greet” activities are accommodated within virtual workspaces designed for this purpose, providing the same interactive capabilities for conference commencement such as ice-breakers and games involving activities like treasure hunts.

Because virtual world technology is applicable across many training, communication and collaboration opportunities in the clinical development and life sciences arena, CROs can expand their use of the virtual technology within the business and with clients. A replica of a medical office or clinic environment can be built within the virtual collaborative space. Here CRAs can practice and be evaluated on their job skills by interacting virtually with an office staff while accompanied by a senior member of their management team functioning in the role of mentor and trainer. Or virtual technology can be incorporated with rewards and recognition programs, whereby employees earn points or badges leading to admittance to special events within the virtual world.

Learning trends indicate that high performing corporations are employing a formula of approximately 20% formal learning and 80% informal learning, with a widening of that gap. In addition, communities of practice, blogs, wikis, forums, expert directories and social networking are all important in future learning trends and are fully enabled within the platform. Mobility is a key feature of getting employees what they need when they need it. Virtual world collaboration platforms support all of these capabilities while also bringing two-way engagement back to online learning. By supporting all of these features while reducing costs, CROs can help their clients deliver safe drugs to patients faster.

As previously mentioned, the traditional face-to-face approach is increasingly becoming cost-prohibitive, considering the transportation, lodging and per diem costs for global employees traveling to centralized locations for training. Controlling these costs and reducing the time between hiring and job readiness helps keep clinical research on track to deliver life-changing medical treatments to patients sooner and cost-effectively. Adding virtual world capabilities means that the launch of such a program enables training of considerably more global employees in a shorter time period. Return on investment in such a program can be realized in less than a year.

When establishing an alternative process methodology for your training program, it is important to incorporate metrics around usage and performance that are not only compared retrospectively to demonstrate ROI but are used in a prospective manner to enable continuous improvement and evolution of the program. If the program is designed correctly and appropriately supported, metrics can show that virtual world training is as effective as face-to-face training, is more effective than online training and has a positive impact on employee engagement scores both from a work/life balance standpoint and from an interactive and collaborative standpoint. The Kirkpatrick levels of evaluation are a standardized and industry accepted methodology for training evaluation and effectiveness. There are four levels of evaluation:

• Level 1: Reaction of student
• Level 2: Learning and knowledge assimilation
• Level 3: Behavior change
• Level 4: Results – effect on the business or environment

Using the Kirkpatrick evaluation of a virtual world training program requires planning and coordination, but if designed effectively, results will show that Level 1 feedback from participants indicates a large percentage of them are satisfied or very satisfied with the methodology and comments such as the following are common: “The virtual training was absolutely AMAZING!! It was engaging and made me excited about learning new material (even homework). I would rate this 10X better than in-person training or WebEx meeting. Great job to everyone involved and thank you for such a great learning experience.”

At Kirkpatrick Level 2, scores based on periodic assessments and an end-of-course exam will show an increase in participant knowledge that is comparable to past courses using the traditional methodology, if not superior or trending to the superior.
Kirkpatrick Level 3 scores will show behavior changes specifically tied to the training provided. CRA field assessment and performance scores are traditionally databased. Audit findings can be categorized by investigative site and by CRA and also databased. Over a predetermined time period, scores from these databases can reveal trends and be compared to participation in the virtual training sections.

Kirkpatrick Level 4 will be tied directly to business results, and in the case of virtual world training, likely involve cost savings and productivity measurements, such as time from hire to assignment.

In summary, enterprise mobility allows workers to have access to information and training at any time, anywhere. With workforce trends showing that more employees than ever are working remotely and innovative technology is available to most everyone, a virtual world training solution seems a logical choice. If your goal is to support superior training and process methodologies that enable your customers and partners to reach their goals in more efficient and cost effective manner, then you owe it to your organization to stay on the cutting edge of technology support those initiatives.

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Stacy Weil is an executive director in the Technology, Innovation and Performance group at PPD. She can be reached at [email protected].