Biotech and emerging biopharma companies are leading the charge in clinical development, initiating two-thirds of all new trials. But to successfully move their drug products from preclinical to commercialization, sponsors need smart solutions and expert guidance. They also face mounting pressure to accelerate R&D processes to quickly reach key milestones such as proof of concept. So how can sponsors tackle these challenges?

Optimized clinical trials

Optimized clinical trials play a key role in enhancing the success and efficiency of drug development. By integrating strategies across regulatory compliance, clinical development and market access, these trials unlock the full potential of biotech assets. Innovative trial designs accelerate decision-making, enhance productivity and provide the flexibility needed to navigate the complexities of clinical and commercial landscapes. These advancements are key to meeting evolving regulatory standards, reducing time-to-market and ultimately delivering effective treatments to patients faster and more reliably.

To maximize biotech asset success, optimized clinical trials employ integrated strategies that span the wide-range of needs that biopharma sponsors face from drug development strategy and regulatory to clinical development and infrastructure. Emphasizing novel trial designs, we improve efficiency and flexibility in both clinical and commercial development. Our approach includes external comparators, adaptive methods, single-arm and randomized trials, adaptive master protocols, decentralized approaches and innovations in devices and endpoints. By working closely with clients to develop the best protocols, we ensure these designs achieve desired trial outcomes, accelerating decision-making and enhancing overall productivity.

Decentralized clinical trials

Decentralized Clinical Trials (DCT) are changing the way we conduct clinical research. By leveraging technology, these trials streamline processes, cut down timelines and save costs for sponsors.

Imagine being able to participate in a clinical trial without constantly visiting a site. Using platforms like interactive response technology (IRT) and electronic clinical outcome assessments (eCOA), these trials bring the study to the patient. They use direct-to-patient (DTP) drug shipments, wearables, tele-visits and remote eConsent to minimize the need for traditional onsite visits. This approach makes it easier for patients to take part and improves data collection efficiency. By embracing home health visits with connected devices, DCT enhances patient engagement while speeding up the pace and accessibility of clinical research. Top of Form.

Generative AI: Balancing innovation with caution

These advancements are further amplified by Generative AI, which is transforming clinical trials by optimizing operations and enhancing data management from planning to regulatory outcomes. AI quickly analyzes protocols and manages data, making trial processes even more streamlined and effective.

However, embracing AI isn't without its hurdles. Issues like data privacy, security, bias, and accuracy need careful attention. Ensuring accountability means we need solid data tracking, clear validation processes, and proper integration of AI into everyday business practices, always keeping humans in the loop for final decisions.

For biotech sponsors, especially those on unique development paths, success lies in partnering with technology, science and analytics experts. These collaborations help navigate the complexities and fully harness AI's potential while managing risks.

Clinical development designed for biotech

Clinical development tailored for biotech is essential due to the unique challenges and innovative nature of biotech therapies. These therapies, often groundbreaking and highly specialized, require precise trial designs to meet stringent regulatory standards and to identify the right patient populations. Efficient use of resources, integration of biomarkers, and adaptive trial designs are critical to managing the limited resources of biotech firms and accelerating development processes.

By addressing the specific needs and challenges of biotech innovations, clinical development designed for biotech ensures that promising therapies reach patients efficiently and safely. This approach offers flexibility to support commercial and business needs, innovative solutions to tackle development hurdles, data-driven decisions with advanced analytics, small and dedicated teams that are responsive and transparent, access to senior leaders, global resources with a local feel and resources that can ramp up and down based on project needs.

To help biotech sponsors navigate this path forward, we offer a global network of sites as well as experts who specialize in innovative trial designs, which require a unique approach. Our skilled regulatory department reviews synopses and protocols, working closely with clients to develop the best designs for achieving desired trial outcomes. As regulators start to embrace these new methods, we help our clients navigate challenges like smaller target populations and secure the necessary approvals.

Our experienced team customizes trial designs for success, tackling recruitment challenges that often come with traditional randomized control trials. This shift marks a significant step toward more flexible and effective clinical development, ensuring that groundbreaking therapies reach patients faster and more safely.

Emerging biopharma companies are pushing the boundaries with innovative trial designs to make studies more efficient. At IQVIA Biotech, we’re committed to supporting these forward-thinkers by working closely with them to develop the best trial designs and achieve their goals.

Want to learn more about how IQVIA Biotech is helping biotech sponsors navigate the changing landscape of trial design? Download the Insight Brief “Beyond the Benchmark: How Innovative Trial Designs are Transforming Clinical Research” to learn more.