Pharmaceutical Compliance Insights

Publications Newsletters Whitepapers Case Studies Webinars & Events

Using the I GLASS™ Field Based Monitoring Tool

Julie, a sales representative, has been randomly selected for a field ride with a compliance monitor. Her company’s I GLASS™ administrator begins the process by registering Julie in the system and selecting a due date for her field ride. Once registered, Julie’s manager is automatically notified of the pending monitoring activity. If desired by her organization, Julie can be notified through an automated, custom email informing Julie what to expect during the scheduled field ride. During the field ride, the monitor observes Julie’s behavior and records his/her observations and concerns in a fully customized behavioral observation assessment. The scaled responses help the monitor to clearly identify which behaviors do and do not align with the compliance expectations set forth by Julie’s organization. This process allows both internal and external monitors to effectively capture Julie’s acumen and conduct. When an opportunity to directly observe the behavior being tested does not exist, the monitor asks Instant Assessment questions to ensure Julie meets the required standards. Once the assessment is complete, a real-time individual report becomes available with a summary of Julie’s results. If Julie’s results reflect a compliance gap, I GLASS™ automatically triggers an action plan. This prompts the monitor to determine the individual action steps Julie needs to take to close the loop and to select a specific due date for each action step to ensure complaintbehavior in the future.

Launching a Novel Drug with a Contracted Sales Force

Background and Challenge

A privately held pharmaceutical company was preparing for the commercial launch of their first prescription drug. The Executive Management team brought their commercial leaders on board just prior to the product being approved by the FDA. The decision was made to utilize a Contract Sales Organization (CSO) to promote the new product. It was vitally important for the organization to achieve commercial success with their first brand given that their pipeline was built around additional formulations of the same active ingredient. The company recognized the importance of entering the market with a reputation for conducting compliant promotional activities while also maximizing sales effectiveness with their CSO. WLH was sought out to help develop the organization’s compliance function and create a field observation and monitoring process. WLH helped the organization to define how they would work with their CSO to create accountability and to leverage the limited scale of their internal commercial team to establish oversight.

Approach and Deliverables

WLH worked closely with the organization’s Chief Compliance Officer to accomplish the following:

  • Define the mission, goals, and unmet needs of the compliance department

  • Create processes to identify and mitigate key areas of risks in the commercial function

  • Engage the Marketing, Medical, and Sales leads to define desired promotional behaviors

  • Establish a process for collaboration between the company’s commercial leaders and the leaders of the CSO

  • Create organizational standards for compliant promotional activities, field coaching, and sales effectiveness

  • Provide behavioral-based training to reinforce expectations for compliance and accountability with CSO leadership

  • Implement the I GLASS™ Field Based Monitoring process with their CSO as well as their Field Medical and Promotional Speaker Program teams

  • Generate real-time reports following observations to inform field coaching

  • Develop group reporting tools to show trends and validate compliance efforts

Results Achieved

WLH helped the client to operationalize their compliance function, clarify their promotional strategies, and effectively engage with their CSO. All project deliverables were on time and on budget. The Contract Sales Organization successfully met the initial performance expectations specified by the company. A defensible process to support appropriate promotional activities was implemented and has been maintained by the company with ongoing support from WLH.

Global Pharmaceutical Manufacturer’s Reactive Response to a Corporate Integrity Agreement (CIA)

Background and Challenge

While a global pharmaceutical company was under a Corporate Integrity Agreement (CIA), an associated brand was issued Risk Evaluation Mitigation Strategies (REMS) requirements. The compliance team had recently gone through substantial personnel and leadership changes. They needed a better way to coordinate, track, and document their oversight activities to demonstrate CIA and REMS adherence. They also needed an effective method to monitor the activities of their Medical Liaisons and Promotional Speaker programs.

The company turned to WLH for compliance support and their I GLASS™ Field Based Monitoring system. The goal was to quickly design a process that incorporated the best practices of pharmaceutical compliance and fully supported the CIA and REMS requirements for the brand. During the initial engagement, WLH also recognized the need for the compliance team to better engage with the sales and brand marketing teams. As a result, WLH supported the organizational alignment of these functions.

Approach and Deliverables

WLH conducted a rigorous evaluation of the promotional materials and approved scientific literature in place to support the brand. WLH then completed an analysis of the company’s compliance procedures related to training, product promotion, and meeting internal and external reporting requirements. The company looked to WLH to deliver:

  • Improvements to the structure, alignment, and responsibilities of the compliance department

  • Documented working agreements to foster greater collaboration between Compliance, Sales, and Marketing

  • Updated SOPs to communicate company compliance expectations for interactions with prescribers

  • Behavior-based training to advance the capabilities of the compliance monitors

  • Product-specific assessment audits to be used during field based monitoring

  • I GLASS™ field based monitoring process

  • Automated compliance data collection process to facilitate delivery of REMS data to the US Government

  • Customized reports to identify trends and validate compliance requirements

Results

The organization further expanded the scale of their Compliance team and implemented a new, web-based approach to field based monitoring. WLH was then asked to expand the I GLASS™ System to support the compliance needs of the company’s other brands. Manual data collection and storage processes were eliminated.

Combining Sales Coaching and Field Based Compliance Monitoring to Improve Results

Background and Challenge

A rapidly growing biotech company was interested in improving organizational efficiency and sales performance. As part of the effort, they conducted a critical review of several departmental functions, looking for opportunities to eliminate unnecessary redundancies. At the same time, the sales team leaders were struggling to align on a coaching model and method to document coaching feedback. The organization wanted to address these challenges before launching their next product.

WLH had previously implemented the I GLASS™ Field Based Monitoring system within the company. The I GLASS™ system was being used exclusively for compliance monitoring by a third party auditing firm. The organization’s commercial leader informed WLH of their efforts to increase efficiency and improve their coaching results. WLH suggested leveraging the I GLASS™ system capabilities to help achieve the stated goals.

Approach and Deliverables

WLH conducted a series of interviews with company personnel in several departments including Sales, Sales Operations, Business Technology, Compliance, and Training. After conducting an in-depth analysis of the current state and gaining a clear understanding of the desired state, WLH provided the commercial leader with a set of recommendations for improvement. The recommendations included the following:

  • Eliminate the third party auditing team and transfer monitoring responsibilities to internal staff – ideally the sales managers

  • Use the I GLASS™ system to monitor for compliance and to automate the coaching documentation process

  • Identify the best coaching practices of their sales managers and leverage the expertise of WLH to create a customized coaching model for the organization

  • Provide behavior-based training to reinforce and develop coaching capabilities

  • Provide training for the sales managers on using I GLASS™ for coaching and compliance documentation

Results

The organization took action on the above WLH recommendations. They achieved first year savings of more than $100K by eliminating the third party monitors. The coaching model and manager training helped to improve performance and increase engagement. The sales leaders used I GLASS™ to provide coaching feedback and the sales reps received documented feedback following 90% of field rides. This was a 45% improvement in documented feedback.