Insights, updates, and thought leadership on AI-powered MLR review and pharmaceutical marketing compliance.
Healthcare delivery is undergoing a structural shift as direct-to-consumer (DTC) access to medications expands rapidly. Patients are no longer relying exclusively on traditional in-office prescribing and pharmacy dispensing models.
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The new edition of the Pharmaceutical Compliance and Enforcement Answer Book just dropped—edited by Howard Dorfman, a recognized regulatory, legal, and compliance expert. And if you've spent any time in medical, legal, or regulatory review, your first reaction might be: Do we really need another compliance book?
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Beginning in September 2025, FDA significantly increased its enforcement activities related to pharmaceutical advertising, issuing dozens of Untitled Letters criticizing company promotional messaging.
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Agentic AI has quickly become one of the most talked-about concepts in artificial intelligence. But in highly regulated environments—like pharmaceutical promotion, medical communications, and scientific exchange, the term needs far more precision than catchy headlines provide.
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I was inspired to write this blog to help the industry adopt a shared baseline education on how AI works in the context of promotional review, specifically speeding up the MLR review process without sacrificing accuracy.
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For all of us working in life sciences, the ripple effect of what happened in September with the FDA's recent wave of enforcement activity, driven by a new HHS directive, caught the entire industry off guard. That's why I can't wait to moderate a special one-hour webinar on November 20 at 2:00 p.m. ET in partnership with BIO.
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The coordinator role rarely gets the spotlight but quietly keeps the entire promotional review machine moving. Coordinators sit at the intersection of marketing ambition and regulatory precision — the unsung heroes who make sure every asset, every claim, every footnote moves through the process without derailing.
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I spent an invigorating two days attending the Momentum 6th Annual Promotional Review Summit in Philadelphia on October 13 – 14, and there was a lot to discuss. The conference focused on evaluating strategies for measuring effectiveness, streamlining workflow, and ensuring compliance in the wake of the recent FDA Enforcement.
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Pharma and Med Device companies are increasingly looking to automate the most repetitive and time-consuming business-critical marketing tasks using AI. Partnerships between AI software providers and their clients are extremely important.
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I had the pleasure of interviewing regulatory, compliance and legal expert, Howard Dorfman, JD, about the recent crackdowns on promotion by the FDA's Office of Prescription Drug Promotion (OPDP). Claims libraries rose to the top as an effective approach to mitigate risk and strengthen trust with regulators.
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With FDA cracking down on promotional materials, there's never been a better time to implement AI-solutions that precheck content to ensure compliance with government regulations. AI innovation must be tightly aligned with business needs and corporate readiness.
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There's no shortage of content out there warning about the risks of using GenAI on its own—especially when it's not grounded in structured data. We've seen firsthand how hallucinations can slip through even the most polished outputs when there's no logical framework behind the words.
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Dennis Rodman, leading expert in GxP systems and digital validation, shares his insights on AI. His core thesis: the rigorous principles used to control sterile pharmaceutical manufacturing facilities can and should be directly applied to managing AI models.
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Given the importance of ensuring confidence in findings from AI-powered prechecking solutions, we've put together a list of questions that should be on every company's list as they evaluate vendors with the objective of greater MLR efficiency.
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SecureCHEK AI has received the 2024 Pharmaceutical Technology Excellence Award in multiple categories in recognition of the AI software's ability to enhance the speed and capacity for content development and MLR review.
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It's important to home in on what you want to accomplish with AI technology. Do you want to increase editor and coordinator productivity so more materials can be checked prior to MLR review? The impact of automation is immediate and measurable.
Read MoreThrive AI Health has committed to helping people boost their wellness outcomes using AI to make suggestions about sleeping, eating, and exercising. Despite the positive impact of personalization, pharmaceutical marketers continue to grapple with scaling this strategy.
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GenAI tools create industrial-scale slop, defined as low-quality, inaccurate content that may look polished but is riddled with errors. Content generated through GenAI queries can frequently deliver flawed outputs including misleading efficacy claims and fabricated citations.
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Label updates can be a heavy lift for pharmaceutical companies and their promotional agencies which is why SecureCHEK AI offers an automated label update process using artificial intelligence to speed materials to market and ensure quality control.
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A study published by The Data Provenance Organization has raised questions about the availability of content for building out AI. The Washington Post says data is drying up based on the first, large-scale audit of the web sources underlying the massive training of modern, general-purpose AI.
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If you have decided to focus your AI pilot on increasing MLR efficiency, there are five smart steps to ensure success. MLR efficiency is an excellent use case because it represents a big pain point in business today.
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The 80/20 rule (also known as the Pareto Principle) states that roughly 20% of efforts drive 80% of the results. In the context of AI, this means that a small subset of use cases will drive measurable business value for an organization.
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In the pharmaceutical and medical device industries security, privacy, and regulatory compliance aren't just checkboxes — they're mission critical. That's why we're proud of our SOC 2 Type II certification. Your data is in safe hands.
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Message consistency and compliance in the fast-moving world of prescription product marketing is imperative. With the growing use of generative AI in content development, teams are under more pressure than ever to get messaging right and in compliance.
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If you are evaluating software companies to automate marketing processes and shorten MLR, inquire whether they have a SOC 2 certification. SOC 2 is an impartial attestation that a company has a robust cybersecurity compliance framework.
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Prechecking software can reduce MLR reviews. But how do you choose the one that's right for you? The first criterion on your shopping list must be accuracy, which means a pre-checking solution that's robust enough to be up to the task.
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The need for increasing amounts of content across more channels means it cannot be managed manually. Innovative companies are exploring the utilization of AI for prechecking content pre-MLR submission to ensure it is accurate, on-brand, and compliant with business standards.
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Proofing the ISI for format and text deviations is as tedious as it is critical to ensure promotional materials are in compliance with government regulations. That's why an AI software solution that automatically and instantly detects deviations in the ISI is welcome news.
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SecureCHEK AI, Inc. is proud to announce that our company is now a Veeva AI Partner focused on delivering seamless integration with Veeva PromoMats to amplify efficiency for mutual pharmaceutical and medical device customers.
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The March issue of PM360 captures AI's impact on pharma by sharing perspectives from industry experts. Starting small is always a smart idea when implementing AI. One low-risk baby step: zero in on use cases where it makes business sense to replace manual and repetitive marketing tasks with automation.
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I was chatting with two industry veterans, colleagues, and dear friends of mine in the healthcare marketing space. They shared a recent IBM report with me that found 70% of C-suite executives don't believe their organizations are ready to integrate Gen-AI into their companies.
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There are hundreds of medical abbreviations commonly used in pharmaceutical marketing, encompassing terms related to drug administration, dosage frequencies, medical conditions, and clinical trial data. Manually checking the accuracy of these abbreviations is tedious and time-consuming.
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Our company executes dozens of pilots and has honed the process in partnerships with the pharmaceutical clients looking to validate the use of SecureCHEK AI in their organization. This White Paper provides three imperatives for executing a successful pilot.
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The pharmaceutical industry and its promotional agencies have been prechecking content for decades. A manual process leads to more comments, rewrites and re-reviews by increasing the likelihood of errors and redundancies.
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Shane McKinnon, Founder of OEM Group, has outlined several simple, low barrier ways to start experimenting with different AI based applications and use cases that act as an extension, or copilot to optimize human effort.
Read MoreShane McKinnon, Founder of OEM Group, provides an outlook on AI in general, what it means for the marketing industry, and ways business leaders can start experimenting with different use cases.
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Tristan Reid, the Engagement Director at Ward7, highlights that traditional agency production models lead to escalating costs with increasing number of assets, presenting a challenge for clients aiming to create large volumes of hyper-personalized materials.
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Does generative AI make content marketing easier or just hard in a different way? This blog, written by Aprimo CEO Erik Huddleston, addresses the challenges with context and metadata, budgeting complexity and safety/compliance.
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Our partner, Aprimo, shares this informative perspective on the pros and cons of generative AI to demystify GPT and AI language models. Organizations must establish robust governance frameworks to mitigate risks and challenges.
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We are thrilled to announce our partnership with Aprimo, a leading provider of content operations technology, to revolutionize content operations in the pharmaceutical industry.
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The need for increasing amounts of content across more channels means it cannot be managed manually. The surge in content creation is straining resources while pressure mounts to do more with less–and do it faster.
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At the annual DIA Ad/Prom Conference, a panel on Innovation in Promotional Review featured a healthcare advertising agency presenting its findings on SecureCHEK AI software.
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There is more content than ever coming into MLR. Everyone is focused on personalization, content enablement, and modular content. The surge in content creation strains resources while pressure mounts to do more with less—and do it faster.
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The current MLR process is well known to be complicated in the face of increasing content volume and personalization demands. During a recent industry webinar, a panel of experts delved into these challenges and the role of technology in improving the process.
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Twenty years later the Moneyball principles have become part of today's paradigm for business transformation. Pharma can learn from these clear-cut strategies for changing the game using data analytics, predictive analysis, and artificial intelligence.
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Despite vast advancements in technology, drug and medical device companies still use a manual process to create claims libraries, check promotional content for FDA compliance, and implement label changes. Make 2022 the year your company transforms an old-fashioned manual content review process into a modern marketing machine using artificial intelligence.
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