--- title: "Why Medical Inquiry Volumes Are Rising, and Why Your Current MI Model May Not Be Built for It" description: "Medical inquiry volumes are rising as products, patient expectations and regulatory requirements grow more complex. Is your Medical Information model ready?" url: https://qbdgroup.com/en/blog/rising-medical-inquiry-volumes-mi-model type: "Blog post" language: en published: 2026-09-09 author: "María Corrales" category: "Pharmacovigilance" publisher: "QbD Group" citation: "QbD Group, \"Why Medical Inquiry Volumes Are Rising, and Why Your Current MI Model May Not Be Built for It\", https://qbdgroup.com/en/blog/rising-medical-inquiry-volumes-mi-model" --- # Why Medical Inquiry Volumes Are Rising, and Why Your Current MI Model May Not Be Built for It > Medical inquiry volumes are rising as products, patient expectations and regulatory requirements grow more complex. Is your Medical Information model ready? Medical Information (MI) teams rarely get to plan around a stable baseline anymore. Inquiry volume keeps climbing, and it is not climbing for one reason. It is the combined result of a more complex product landscape, a more informed and digitally active patient population, and a regulatory environment that expects more documentation around every interaction. For many pharma companies, the model that once handled Medical Information effectively is no longer built for the volume or complexity it needs to absorb today. **In This Blog Post** - Why increasingly complex pipelines generate more complex medical inquiries - How patient expectations and communication channels are changing - Why growing inquiry volumes also increase compliance pressure - Where traditional Medical Information models start to struggle - How in-house, hybrid and outsourced MI models can respond ## More Complex Pipelines Mean More Complex Medical Inquiries The European Medicines Agency (EMA) recommended 104 human medicines for marketing authorisation in 2025, 38 of them containing a new active substance never previously authorised in the EU. The agency''s own review of the year also points to the growing importance of complex biologics and cell and gene therapies. On top of that, EMA recommended **41 new biosimilars in 2025**, its highest annual number to date. That growth adds another layer of nuance to how a product''s safety and efficacy profile needs to be communicated. Advanced Therapy Medicinal Products (ATMPs), biosimilars and precision oncology treatments come with mechanisms of action, administration protocols and safety considerations that can be significantly more complex to explain than those of a traditional small-molecule medicine. Medical Information teams are the ones fielding the resulting questions from healthcare professionals (HCPs) and patients trying to make sense of them. **As pipelines become more specialised, the expertise required within Medical Information has to evolve with them.** ## Patients Are Asking More, and Asking Differently Increasing product complexity coincides with another important shift: **who is asking questions and how they expect those questions to be answered.** EMA''s engagement framework with patients and consumers formally recognises that patients are no longer passive recipients of medical information. They are active participants who increasingly expect direct access to information about a medicine''s benefits and risks, rather than relying exclusively on information passed down through a prescriber. That expectation now plays out across more channels than many traditional MI models were designed to monitor: - web forms - email - social platforms - AI-driven search and digital tools - telephone inquiries - in-person interactions Volume no longer arrives in a predictable rhythm through a single channel. **It arrives from everywhere, all the time.** ## The Regulatory Bar for Medical Information Keeps Rising Too None of this growth is happening in a compliance vacuum. Regulatory expectations continue to emphasise the appropriate capture of safety-relevant information wherever it surfaces, including through routine medical inquiries, and the documentation and traceability needed to connect that information to Pharmacovigilance processes. This creates an important additional pressure on growing MI functions. An MI team handling more inquiries, about more complex products, through more channels is also more exposed when documentation or escalation falls behind. Because a missed adverse event captured through a Medical Information channel is still a missed adverse event. **More inquiries do not simply create a capacity challenge. They create a governance and compliance challenge too.** ## Why Traditional Medical Information Models Struggle to Keep Up Put these three forces together: - more complex products - more active and digitally engaged patients - tighter documentation expectations and it becomes clear why a static Medical Information model starts to strain. Teams sized for yesterday''s volume can find themselves triaging faster than they can verify, or verifying carefully at the cost of response time. Either way, quality or compliance risk can begin to creep in. Scaling headcount alone is rarely the complete answer. The expertise required to handle a gene therapy inquiry is not necessarily the same as that required for a well-established small-molecule FAQ. Building that breadth of expertise entirely in-house takes time, and many MI teams need flexibility before permanent internal capacity can catch up. The question therefore becomes broader than: **Do we have enough people?** It becomes: **Is our Medical Information operating model still appropriate for the inquiries we are now receiving?** ## Choosing the Right Medical Information Operating Model There is no single operating model that works for every pharmaceutical company. Some organisations will keep Medical Information fully in-house and invest in the specialist expertise their pipeline increasingly demands. Others may adopt a **hybrid model**, keeping core inquiry handling internal while bringing in specialist support for advanced therapies, specific markets or periods of higher inquiry volume. Others may conclude that an **outsourced or co-sourced model** is the more sustainable option, particularly where capacity needs to flex with volume and therapy complexity while maintaining a close connection between Medical Information and Pharmacovigilance. None of these approaches is automatically the right answer. The right model depends on: - where the company''s pipeline is heading - which therapeutic areas require specialist expertise - how predictable inquiry volumes are - which channels need to be supported - how much complexity the existing team can genuinely absorb - whether response quality, documentation or the audit trail are beginning to suffer The goal is not outsourcing for the sake of outsourcing, or keeping activities in-house simply because that is how they have always been managed. It is building an MI model that can absorb change **before that change starts affecting quality or compliance.** ## Build a Medical Information Model That Can Scale With You Medical inquiry volumes and complexity are unlikely to level off on their own. New products will continue to generate new scientific questions. Patients and healthcare professionals will continue to expect information across more channels. And every interaction will still need to meet the documentation, escalation and quality standards expected of a regulated Medical Information function. A model that is only adjusted once it begins to strain will always be catching up. The better question is whether your Medical Information model is designed to adapt before it reaches that point. QbD Group supports pharmaceutical and biotech companies with flexible Medical Information services that can complement existing teams or provide a broader outsourced solution, while keeping Medical Information closely integrated with Pharmacovigilance. Is your current MI model keeping pace with your pipeline? [Explore our Medical Information Services](https://qbdgroup.com/en/services/pharmacovigilance/comprehensive-medical-information-services) and discover how QbD Group can help you build the right model for your organisation. ## Sources - European Medicines Agency (EMA) — [Human medicines in 2025](https://www.ema.europa.eu/en/news/human-medicines-2025) - European Medicines Agency (EMA) — [EMA''s 2025 annual report shows strong approval numbers for human and veterinary medicines](https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines) - European Medicines Agency (EMA) — [Engagement framework: European Medicines Agency and patients, consumers and their organisations](https://www.ema.europa.eu/en/documents/other/engagement-framework-european-medicines-agency-and-patients-consumers-and-their-organisations_en.pdf) --- Source: https://qbdgroup.com/en/blog/rising-medical-inquiry-volumes-mi-model — © QbD Group. Quote freely with attribution and a link back.