Life science companies operate under some of the most stringent compliance requirements. The US market’s pharmacovigilance reporting requirements is an obvious example.

Most pharmaceuticals, biotech, and other life science companies in the country strictly limit the way their field force representatives gather information after visiting with healthcare professionals (HCPs). They require field force reps to use pre-approved drop-down menus to record CRM notes. Doing this offers peace of mind in terms of compliance, but unfortunately, it holds businesses back in terms of discovering and logging important business insights. With drop down menus, two things happen that hamstring business operations:

  1. Rich market insights from HCPs are never funneled back to R&D or marketing teams, which severely limits field force operations’ ROI.
  2. Regulatory risks go underground. Field reps will inevitably still take notes somewhere, because they need to recollect meetings to do their jobs. They may jot things down on paper, on personal tablets or other devices. Now compliance has no visibility into any issues related to Adverse Events (AEs) or off-label promotion. But these notes are still ultimately discoverable from a legal standpoint.

On the whole, constrained note-taking options greatly limit decision-making processes, hamper business plans, and have the potential to accrue incredible regulatory risk. Using free-text notes for HCP interactions seems to be the solution – but first, companies need to be able to cover their CRM compliance gaps.

The Barriers to Free-Text Adoption

According to research from Omdia, 58% of companies view compliance as a barrier to entering new markets. For the life sciences industry alone, two of the main regulators enforce a growing list of compliance regulations and requirements:

  • Food and Drug Administration (FDA) - The Title 21 Code of Federal Relations (CFR) used by the FDA and other US agencies govern how food, drugs, cosmetics and other public health products are produced, tested, and released. The FDA can also conduct inspections for various reasons – from pre-qualification, routine inspection, or investigation – so companies need to be always ready.
  • International Organization for Standardization (ISO) - Independent regulatory organization ISO establishes standards to ensure safety and quality of various products. Some of the more pressing regulatory standards that life science companies need to adhere to are:
    • ISO 9001: Quality Management System For ISO 9001: 2015
    • ISO 17025: Laboratory Testing And Collaboration
    • ISO 31000: Risk Management

The FDA itself sends out nearly a hundred warning letters to various companies every year for compliance violations. Sometimes, these end up becoming expensive litigations and court trials. In fact, according to the Department of Justice, the largest fine levied for failure to report adverse events is $3B.

Automating Pharmacovigilance for CRM Free Text Notes

Some organizations see risk management for CRM compliance as reactive and costly. However, it doesn’t always have to be this way. Risk management can be proactive, with the right solution.

SafeGuard Cyber’s CRM compliance solution empowers life science companies and enterprises to enable free-text for their CRM notes with peace of mind. With SafeGuard Cyber, organizations can automate their pharmacovigilance (PV) compliance, allowing them to detect adverse events, off-label promotion, and more.

SafeGuard Cyber’s solution processes and understands free-text notes through Natural Language Understanding (NLU) capabilities. It is multilingual, and provides risk reduction at scale. Our fully customizable policy engine, built upon our deep experience in global deployments for life science companies, enables quick adaptation to new business conditions.

The Benefits of Free-Text CRM Notes

Automating PV compliance for CRM text notes has been found to enable higher quality HCP interactions, better product delivery, and revenue growth.

Moreover, organizations reap the following benefits:

  • Gain 100% supervision coverage with automation to replace costly sampling methods
  • Reduce oversight costs by up to 80% 
  • Earlier identification of policy violations & risk
  • Increased business agility and eliminate of friction between field force operations and compliance

Case in point: A global pharmaceutical company wanted to improve the visibility and details in their CRM. Their field force reps HCP interactions used free-text for note taking, which massively increased the amount of content for CRM compliance reviews.

Through SafeGuard Cyber’s platform, the pharma enterprise now automates the compliance and regulatory review process of over 100,000 free-text CRM notes and records per day, in multiple languages. Doing so has enabled them to cut manual review costs by $3 million per month.

To see more examples of businesses achieving compliance and growth, read our success stories here.


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