linical trials are evolving, but not fast enough. Despite major advances in science and technology, many studies continue to be slowed by recruitment barriers, participant burden, and structural inequities that keep large segments of the population out of research entirely. At the same time, healthcare delivery is rapidly shifting toward more flexible, home-based models, creating a pivotal moment for the clinical research enterprise to rethink how—and where—trials are conducted.

raditional clinical trials rely on structured interactions between clinicians and patients, often one-sided and incremental. The rise of decentralized clinical trials (DCTs), designed to bring trials closer to patients by leveraging digital tools and remote monitoring, has complicated this dynamic. Despite expanding access, DCTs often reduce face-to-face interactions, increasing the risk that patients will feel isolated and disengaged, if not outright unsafe.

early 40 years ago, the first regulatory guidance on monitoring clinical trials in the US was published by the US Food and Drug Administration (FDA). For the next two decades, traditional onsite monitoring was performed by Clinical Research Associates (CRAs)* who relied primarily on 100% Source Document Verification (SDV) as the predominant mechanism to fulfill regulatory requirements to monitor the progress of clinical trials and to ensure human subject protection and data integrity.

or decades, Medical Affairs has been the guardian of scientifically accurate communication in the pharmaceutical industry. As healthcare evolves toward greater personalization, digital enablement, and patient-centricity, the Medical Affairs function is stepping into a new era, one that demands partnership, agility, and enterprise thinking to deliver their remit.

he in vitro Diagnostic Medical Devices Regulation (IVDR) adopted in 2017 updated the rules applicable to in vitro diagnostic (IVD) medical devices for human use on the European Union (EU) market and introduced stricter pre- and post-market requirements, but also added rules on the conduct of performance studies for IVD medical devices. Since the IVDR became enforceable in 2022, developers of both medicines and IVDs (including companion diagnostics) have run into a tangle of challenges.

arying country-specific regulatory and reimbursement requirements, divergent legal frameworks, and inconsistent interpretation of the international guidelines create a fragmented regulatory approval process for advanced therapy medicinal products (ATMPs). The fragmentation also exists for achieving ATMP access, particularly in emerging markets (EM), where affordability constraints and limited reimbursement capacity magnify access barriers. The time for emerging markets to join the decision table and the efforts to increase access to these therapies across the world has arrived. Increasingly today, new alliances emerge among countries that share a forward-looking mindset and a willingness to collaborate and improve patient outcomes. This includes, as a crucial element, the willingness to maintain a high level of public health protection while facilitating and smoothing the path for ATMPs to reach the patients who need them across the globe, especially in EM settings.

magine beginning a new treatment and not knowing if you’ll be able to manage the side effects—or if those side effects will be truly recognized/understood by your healthcare providers. Toxicities experienced over the course of a treatment (through both clinical trials and clinical practice) have real consequences as patients live with (and often quietly endure) the burdens and surprises that can accompany innovative therapies. In response to these challenges, there are new ways of incorporating patient perspectives into both drug development and the way treatments are assessed for approval.

iologics treat many complex, chronic conditions. In the US, biologics account for around 2% of prescriptions but close to 50% of overall drug spending. Biosimilars, clinically equivalent but lower-cost alternatives, offer an efficient solution to reduce healthcare costs and expand access. Despite their potential, biosimilars continue to face significant regulatory and market challenges that limit their impact. In a world of escalating biologic costs, many patients are priced out. Biosimilars could offer an answer, but obstacles persist.

harmaceutical manufacturing improvements that could benefit patients quickly often take months to implement. For example, a packaging update designed to reduce medication errors may sit idle across multiple markets because regulators require an updated Certificate of Pharmaceutical Product (CPP), typically issued by a reference authority such as the European Medicines Agency (EMA) or US Food & Drug Administration (FDA), before a post-approval change (PAC) submission can be filed in their own jurisdiction. Until the CPP is reissued, review timelines cannot begin.

he pharmaceutical regulatory policy landscape requires efficiency in processing extensive amounts of information derived from multiple external sources of intelligence and trade association engagement. This article examines how one global pharmaceutical company’s Regulatory Policy Team used Generative AI to achieve a reduction in reporting time for their engagement with external trade associations (key stakeholders in policy engagement), while improving decision-making capabilities and providing a roadmap for similar implementations.

n the pursuit of a sustainable future, the healthcare sector faces the critical challenge of integrating environmental responsibility with its core mission of patient care and innovation. This challenge was a central theme of the first article in this series, Sustainable Healthcare: Balancing Patient Care and Environmental Impact, an exploration into how the biotechnology and pharmaceutical industry is navigating this complex landscape.