Pharmaceutical Compliance Challenges

Pharmaceutical Compliance Challenges

WLH has helped many clients address a wide range of challenges related to pharmaceutical compliance. The I GLASS™ tool can help transform any compliance program. Organizations that benefit most from upgrading their compliance program using the I GLASS™ tool are those that have:

Outdated Monitoring Practices

Many compliance programs in the pharmaceutical industry rely on spreadsheets and paper-based monitoring tools to document their compliance monitoring activities. I GLASS™ simplifies and improves this inefficient and error-prone process by automating the assembly of field ride observation data, detailed reports, and follow-up action plans.

New Product Launches

Reinforcement of compliant sales messaging is a critical step to follow when planning the successful launch of a pharmaceutical product. I GLASS™ promotes fair and balanced sales messaging and compliant conduct in all interactions with Healthcare Professionals. I GLASS™ helps ensure these practices and behaviors are built into the fabric of any new field force.

REMS or CIA Requirements

REMS Requirements:

Products with specific risk profiles are often under additional scrutiny due to their FDA-approved product label indications, side-effects, and black box warnings. In these instances, it is important to have a process in place that allows an organization to demonstrate and adequately report that they are working to proactively mitigate risks associated with these products. I GLASS™ reinforces the desired behaviors associated with truthful and non-misleading sales messaging, sample distribution, and handling adverse events. The I GLASS™ system provides automated, defensible data that helps reduce the manual workload involved in delivering reports to the government.

CIA Requirements:

The I GLASS™ system enables organizations to meet their CIA monitoring requirements in an effective and defensible manner. The system can be customized and fully launched under tight CIA timelines. This web-based platform supports secure, third-party access, enabling internal and external monitors to complete assessments. I GLASS™ system-automated notifications reduce the likelihood of additional fines and/or requirements and eliminates the risks associated with manual procedures.

Disconnected Sales Effectiveness and Compliance Efforts

I GLASS™ is more than a compliance monitoring software platform. The I GLASS Method™ was designed by compliance and sales effectiveness experts to integrate compliance into field sales activities, thereby incorporating field coaching efforts. I GLASS™ improves sales effectiveness and promotes compliance.

Contracted Field Forces

When working with an external field force, two fundamental concerns are transparency and oversight. The I GLASS Method™ enables companies with contract sales organizations (CSOs) to provide consistent reinforcement of compliant sales conduct and messaging, whether the designated monitors are internal or contracted field managers. The I GLASS™ real-time report provides instant oversight of the sales force and enables the organization to take immediate action to address potential compliance violations.