The journey from compound discovery to market-ready pharmaceutical product is long, complex, and resource-intensive. Only about 1 in 5,000 drug candidates make it to patients, underscoring the need for robust strategies at every stage of development. Medical Information (MI) services are instrumental Product Lifecycle Management (PLM)—ensuring safety, efficacy, and compliance while driving value and maintaining a patient-centric focus.
Global pharmaceutical companies invest approximately £140 billion annually in researching and developing new medicines. Leveraging MI throughout the lifecycle not only maximizes this investment but also supports efforts to differentiate products in a competitive market, respond to evolving healthcare needs, and extend commercial viability.
At every stage—development, commercialization, and post-marketing support—MI services provide essential support. Let's explore how they contribute to each phase.
Development Phase: Regulatory Compliance & Approval
The initial phase, known as drug discovery, focuses on identifying new compounds that could have therapeutic effects. In these early stages, navigating global regulatory frameworks is a primary challenge. Each region brings unique requirements, healthcare system nuances, and data expectations.
MI teams provide essential support by:
- Developing and maintaining accurate, up-to-date product information.
- Supporting regulatory documentation and submissions for drug approvals.
- Ensuring alignment with evolving global and regional compliance standards.
These activities lay the groundwork for successful approvals and ensure data integrity from the outset.
Commercialization Phase: Supporting Market Launch and Safe Use
Once a drug is approved, it enters the market exclusivity period—the time before its first generic competitor is introduced—the focus shifts to launch execution, stakeholder education, and safety communication. During this period, MI services become a vital touchpoint for external audiences.
Key contributions include:
- Managing high volumes of inquiries from healthcare providers and patients.
- Delivering clear, evidence-based information on efficacy, safety, and usage.
- Supporting market access and reimbursement processes, which vary significantly across Europe and the U.S.
MI plays a pivotal role in ensuring the safe and effective use of medicines, directly supporting both patient outcomes and brand trust.
Post-Marketing Phase: Sustaining Product Relevance and Safety
After launch, maintaining a product’s value, compliance, and long-term success requires ongoing adaptation. MI services continue to provide strategic support through:
- Pharmacovigilance: Collecting and monitoring real-world data to identify safety concerns and adverse events.
- Lifecycle Management: Informing decisions on label expansions, new indications, or formulation updates based on patient and healthcare provider feedback.
- End-of-Life Planning: Supporting withdrawal strategies and ensuring clear communication with prescribers and patients.
In a dynamic regulatory and commercial landscape, this continuous feedback loop is essential.
Conclusion
Medical Information services serve as the backbone of Product Lifecycle Management in the pharmaceutical industry. From ensuring regulatory approval to market education and safety monitoring, they play a pivotal role in making life-changing therapies accessible to patients worldwide. As the pharmaceutical landscape evolves, MI teams continue to innovate, ensuring drugs remain safe, effective, and compliant—ultimately supporting better healthcare outcomes globally.
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