Three Ways to Accelerate Your Clinical Trials

Discover how to overcome complexity, cut delays and maximize ROI in clinical trials.

In today’s clinical research landscape, it is both essential and challenging to accelerate clinical trials. Speeding up timelines reduces costs, maximizes ROI and ensures that patients receive the treatments they need without unnecessary delays. However, achieving this requires drug developers to navigate a highly complex and competitive environment.

Delays in clinical trials can have significant financial consequences for sponsors. According to the Tufts Center for the Study of Drug Development, each day of delay in a clinical trial results in approximately $40,000 in direct costs. Beyond this, developers face an estimated $500,000 per day in lost potential revenue as drugs are held back from entering the market, underscoring the high stakes of efficiency in drug development.

The challenges are compounded by increasing trial complexities. A recent study of 150 global drug developers conducted by the PPD™ clinical research business of Thermo Fisher Scientific identified the primary drivers of clinical trial complexity – obstacles that extend study timelines, costing sponsors valuable time and money.

• The need to enroll hard-to-find patient populations
• Compliance with intricate and evolving regulatory requirements
• Protocol complexity driven by innovative therapies
• Pressure to capture larger volumes of data and insights
• Persistent demands to shorten development timelines

Despite these hurdles, sponsors have clear opportunities to optimize their strategies, reduce delays and accelerate time to market by harnessing insights from these three areas.

Critical focus areas to fast-track your clinical trials

In the race to bring therapies to market faster, sponsors can gain a competitive edge by addressing three critical areas in their clinical development strategy: artificial intelligence (AI), integrated solutions, and site feasibility, selection and support. By focusing on these aspects, drug developers can streamline operations, overcome common challenges and create efficiencies that shave valuable time off development timelines.

Leveraging AI to streamline studies

AI is transforming clinical trials by addressing some of the most time-consuming and resource-intensive challenges in drug development. Across the study life cycle, AI solutions enable faster, more accurate processes. For instance, AI-driven enrollment planning has reduced enrollment times by up to 30%, significantly accelerating the initiation phase of trials.

Beyond recruitment and retention, AI has expansive potential to reduce operational complexity and improve decision-making, with applications ranging from streamlining regulatory tasks to enabling more efficient site and patient engagement. Key areas where AI is proven to accelerate timelines and improve efficiency in clinical trials include:

• Enhanced data quality control: AI platforms can cut the time needed for database lock by up to 50%, improving data accuracy and accelerating trial closeouts.
• Streamlined regulatory document preparation: Generative AI tools expedite regulatory documentation, reducing administrative bottlenecks and enabling faster compliance with global requirements.
• Protocol digitization for efficiency: Structuring protocol information digitally creates downstream efficiencies, streamlining trial planning and execution.
• Improved site and patient engagement: AI-powered insights support faster site activation and personalized patient outreach, ensuring timely trial progress.
• AI-driven forecasting: Retrospective studies show that AI-enabled forecasting can save up to six weeks in trial timelines, providing a significant competitive advantage.

Successfully integrating AI requires a thoughtful approach, combining advanced tools with human expertise. Sponsors who leverage AI alongside experienced professionals are better positioned to harness its full potential, accelerating trials without compromising quality or compliance.

AI considerations

The emergence of generative AI holds the potential to unlock a wide range of transformative use cases, from small-scale applications to large-scale innovations. However, this groundbreaking technology also introduces a new set of challenges for organizations to navigate.

Focus: With so many opportunities for productivity gains and product enhancements, choosing where to focus your AI resources becomes more difficult. In addition, widespread adoption makes it difficult to monitor and manage utilization.

Scaling from pilot to production: The barriers to AI implementation and adoption have diminished significantly, making it easier than ever to initiate a proof of concept. However, advancing beyond the pilot stage to achieve scaled process adoption requires strategic intention and focused execution.

A single, strategic solution addresses both challenges: selecting project KPIs and assigning target KPI improvements. This is one of the most critical tasks for an effective and well-structured AI initiative.

Defining a clear KPI metric ensures intentionality in value creation. When scoping a project, identifying the KPI and estimating the expected improvement helps prioritize use cases effectively. This approach enables ranking use cases by their potential for generating the highest value, addressing the challenge of determining where to focus efforts.

An effective and measurable KPI also facilitates progression beyond the perpetual proof-of-concept (POC) stage. Empirical evidence of value creation provides a clear decision point for whether to stop or scale a POC. While achieving scalability may present additional technical hurdles, proof of value creates the momentum and incentive necessary to drive the project forward.

Simplifying trials with integrated solutions

Engaging an integrated contract research organization (CRO) and contract development and manufacturing organization (CDMO) partner offers transformative advantages for clinical trials, particularly in today’s demanding landscape. By consolidating services under one umbrella, sponsors can reduce complexity, eliminate redundancies and streamline processes that are often slowed by coordinating multiple siloed vendors.

An integrated model aligns resources and expertise across all trial stages, enabling faster site activation, efficient supply management and smoother transitions between phases. This unified approach accelerates timelines and reduces costs by minimizing the risks of delays caused by miscommunication or fragmented operations. Comprehensive oversight ensures every stage of the trial is aligned, from site selection to regulatory preparation, preserving momentum and keeping trials on track.

When sponsors engage a single, 360-degree CRO and CDMO clinical supply solutions partner, they unlock efficiencies that directly impact speed to market, including:

• Mitigated risks: A single vendor model reduces complexity by consolidating services, fostering early collaboration and visibility, particularly during critical processes like site selection.
• Streamlined processes: Integrated solutions address local needs efficiently, avoiding delays that can arise when managing multiple vendors.
• Faster activation: A single partner ensures all necessary documentation and support are in place, offering a unified dashboard for easy tracking and reporting.
• Simplified communication: A single consolidated point of contact gets to know you personally to remove the burden of trying to navigate between teams.

Sponsors who embrace an integrated solution gain a strategic advantage by accelerating trials without compromising quality or control, ensuring their therapies reach patients faster and more efficiently.

Optimizing site feasibility, selection and support

The efficiency of clinical trials hinges on selecting the right sites and providing the support needed to keep them running smoothly. A misstep in site feasibility or selection — or failing to address site burdens — can lead to costly delays. Studies show that 70% of clinical trials experience startup delays, and nearly 80% fail to meet on-time enrollment targets. Moreover, inadequate site support can exacerbate staff turnover and burnout, further slowing trial progress.

Prioritizing site feasibility, selection and support leads to more efficient operations, improved site performance and accelerated timelines. Key strategies to reduce site-level delays include:

• Streamlined feasibility processes: Introducing electronic confidentiality statements (eCDS) can dramatically reduce feasibility timelines, eliminating weeks or months of delay during study startup. CDA collection is often the most time-consuming step in the feasibility process, with up to 25% of sites completing a CDA but failing to return a completed survey. This bottleneck can be addressed by adjusting the timing of the CDA requirement within the process, streamlining feasibility timelines and reducing site burden while protecting confidential client information. By leveraging an eCDS, the release of key materials — such as the full protocol synopsis and schedule of events — can occur alongside the feasibility survey. This approach safeguards sensitive information and reduces data collection time by 50%, accelerating input into the site selection process and supporting faster trial initiation.
• Reduced questionnaire burden: Sites are burdened with repeatedly completing the same information. Simplifying feasibility surveys by focusing on around 30 essential questions (instead of up to 90) accelerates site evaluations. This ensures sites can respond quickly, enabling faster decision-making and trial activation. These common questions can be databased and combined with the actual site feasibility data.
• Transparency and engagement through digital platforms: Sites want to choose the trials that are the best fit for their patient population. To that end, digital trial platforms allow sites to view and select trials they’re most interested in, fostering engagement and responsiveness. Once a study is identified, sites need more transparency to know where they fit in the site selection process. Providing a digital platform that allows sites to see all trials enables them to select the best-fit study for their institution and the status of the selection process. Such platforms promote faster trial activation and higher engagement, often leading to better enrollment.

Refining site-level processes and reducing administrative strain helps foster stronger, more productive partnerships between sponsors and sites. Sponsors aim to decrease non-enrolling sites, while sites seek greater transparency, streamlined feasibility processes and simplified digital engagement. Tools like digital platforms for trial matching and faster feasibility methods, such as electronic confidentiality agreements, are transforming the industry. These advancements accelerate timelines for clinical trials and create a more efficient and seamless study experience.

Accelerate clinical trial success through strategic partnerships

Speed is essential in clinical trials — not only to reduce costs but also to bring life-changing treatments to patients as quickly as possible. Trial acceleration is a strategic imperative that impacts every phase of drug development, from cost-efficiency to patient outcomes and competitive positioning. Achieving this requires more than just speed for its own sake — it demands a comprehensive approach that addresses critical areas such as AI integration, optimized site selection and strategic partnerships.

The CRO partner you choose plays a critical role in navigating trial complexities and achieving your objectives. The right provider acts as an extension of your team, understanding your unique needs and delivering a tailored mix of solutions to guide your trial from start to finish with maximum efficiency. While trial complexity may seem daunting, the right partnership can simplify the process and ensure success.

The PPD clinical research business of Thermo Fisher Scientific has a long-standing history of trusted partnerships, with many customers relying on us as a collaborative partner to guide their success. With advanced AI capabilities, a global network for data-driven site selection, and 360-degree CRO and CDMO clinical supply solutions, we continuously innovate to chart the best path for our clients, managing risks and maintaining quality with authenticity at every step.

Recognized as the 2024 No. 1 provider of clinical research solutions, our teams deliver 1.5x faster activation from first to last site than the industry average, ensuring that you meet milestones with precision and speed.