In the drug development process, delaying the launch of a successful drug can result in lost sales. Early engagement to kickstart the clinical phase plays a key role in accelerating clinical trials and ultimately increasing revenue by providing earlier market access before competitors. Moreover, being the first to market a drug remains crucial for companies and sponsors, which could be backed by proactive engagement with clinical trial sites and investigators. 

Clinical trial market landscape

The global clinical trial market continues to grow, supported by innovation in biologics, precision medicine, and digital health technologies. Valued at approximately USD 80.7 billion in 2023, the market is projected to grow at a CAGR of around 6.49% from 2024 to 2030, supported by rising R&D and the growing role of contract research organizations (CROs). 

North America accounted for over 50% of the global market share in 2023, a position it is expected to maintain over the coming years. However, the Asia-Pacific region is emerging as the fastest-growing area, driven by increased R&D investment and a broader network of investigators. 

Despite scientific innovation, the success rate from IND filing to FDA approval has steadily declined, pointing to inefficiencies in development timelines and regulatory bottlenecks. Simultaneously, the average daily sales per new drug have decreased, reducing profit margins and underscoring the need for more efficient trial execution. Even as operational costs per trial have decreased, delays remain extremely costly, particularly in high-investment therapeutic areas. Hence, every lost month in development can mean millions in missed revenue opportunities. Let’s take a closer look in the following section. 

The high cost of delays in drug development

Delays in clinical trials carry enormous financial and operational consequences for pharmaceutical companies, highlighting the importance of accelerating clinical trial processes. 

• On average, direct operational costs for Phase II and III trials can reach up to $40,000 per day, with Phase III studies sometimes rising up to $55,700 daily. Even minor delays, therefore, rapidly accumulate substantial expenses over the life of a trial.
• Beyond trial costs, the market impact of delays can be even more significant. A single day’s delay in bringing a drug to market can translate to approximately $800,000 in lost sales. These figures underscore how time-to-market is a critical determinant of commercial success, particularly for high-revenue candidates.

Altogether, these figures highlight why early engagement with sites and investigators is critical for efficient clinical trial management and faster time-to-market.

Streamlining clinical trials through early engagement with sites and investigators

Entering the market early involves more than just claiming a drug’s first arrival. The first drug to market in a therapeutic area often sets the standard of care, builds trust & brand recognition, as well as trust from prescribers. Sponsors can adopt targeted strategies that maximize trial efficiency, optimize site engagement, and mitigate potential delays, such as:

• Preserving revenue and accelerating growth: Early engagement with sites and investigators helps sponsors understand patient populations, site capabilities, and possible challenges before the trial begins. This leads to smoother trial design, fewer delays, and faster approvals. It protects revenue and supports quicker market entry.
• Gaining a competitive advantage: Being first to market lets sponsors reach patients early and build loyalty. Early engagement speeds up clinical trials and lowers the risk of competitors launching first.
• Building confidence: Early engagement gives sponsors confidence in meeting trial timelines and running smooth operations. It also builds trust and creates strong, long-term partnerships.

How early engagement before feasibility can strengthen trial outcomes and enhance market positioning.

In traditional trial startup approaches, feasibility is often considered the starting phase. Although this appears to be a systematic process, it can present unexpected risks to sponsors. For example, it may lead to delays in identifying site limitations, recruitment challenges, or protocol misalignments. This, in turn, shortens the time available to adjust plans or make amendments, ultimately slowing trial progress. 

Further, these operational setbacks translate into clinical disadvantages, such as slower enrollment, delayed deadlines, and impaired data integrity, which eventually affect time-to-market and competitive positioning. The following are a few challenges sponsors may face when they miss early alignment with sites, investigators, and regulators:

• Loss of first-mover advantage: When sponsors delay initiating clinical trials, they risk losing the critical first-mover advantage. Competitors who form early alliances with high-performing or competitive sites can complete trials faster, set new standards of care, and gain prescriber trust sooner.
• Reduced market share capture: Late market entry lowers adoption rates, even for highly effective therapies. Early stakeholder engagement enables sponsors to start trials on time and enter commercial markets faster.
• Reputational setbacks: Companies consistently entering the market late can lose innovative positioning of their brands. Early engagement strategies reinforce a brand’s position as a proactive, market-leading developer.

Practical approaches to accelerate trials through early engagement

Proactively collaborating with regulators, sites, and investigators early on is essential to speeding up clinical trials and preventing late-market concerns. Sponsors can improve site alignment, mitigate operational difficulties, and reduce time-to-market with early engagement. The approaches listed below demonstrate how:

• Design patient-focused trials with early input: Early discussions with investigators, site staff, and patient representatives help set realistic recruitment plans. They also keep participants engaged, reducing dropouts and delays.
• Use data-driven, early site selection: Engage sites early and use real-world data, including electronic health records (EHR), to identify centres with the right patients. This helps secure investigator commitment and speeds up trial start-up. This helps sponsors get investigator commitment and speed up trial start-up.
• Engage investigators before feasibility to understand standard of care: Early talks with investigators help sponsors understand the standard of care (SOC). This ensures the trial protocol aligns with routine practice. Knowing the SOC before feasibility supports selecting the right sites and patients, establishing endpoints, and planning practical protocols. This reduces protocol changes, improves site engagement, and makes recruitment easier. This way, by aligning trials with real-world practice from the start, sponsors can accelerate timelines and support earlier market access.
• Adopt decentralized elements with early site input: Talk to sites early to choose tools like e-consent, wearables, or home visits. This helps create patient-friendly protocols, speeds up enrollment, and improves compliance.
• Start with risk-based, centralized monitoring: Talk to sites early about monitoring plans. Sponsors can focus on high-risk areas. These are the parts of the trial most important for patient safety or key results. For example, critical data points, complex procedures, or sites with less experience. This reduces unnecessary site visits, saves time, and helps the trial run without any hindrance.
• Engage experienced partners early: Engaging experienced partners such as CROs and solution providers helps sponsors build strategic support for every stage of the trial. Experienced CROs, site networks, and feasibility experts provide real-world insights on patient recruitment, site readiness, and regulatory expectations. By collaborating from the start, sponsors can spot challenges early and make informed decisions. This approach streamlines operations, saves time and cost, and improves trial outcomes.
• Gather early market and clinical insights: Talk to investigators and sites to learn how similar therapies are used. Use public data, competitor history, and market research to design realistic, patient-friendly trials. These early insights help plan timelines, run trials efficiently, and support a smoother product launch.

By integrating early engagement at every stage, from regulatory consultation to site activation, sponsors create a continuous development cycle. This approach speeds up clinical timelines. Which in domino effect maximizes commercial potential through earlier market entry, extended exclusivity, and stronger brand leadership.

Conclusion

Delays in starting or completing clinical trials not only delay drug launches but also widen the competitive gap between early and late entrants. A few months can determine market leadership, especially when early launch defines a drug’s success. Most delays result from engaging key stakeholders such as sites, investigators, regulators, and CRO partners, too late. Eventually, it creates neck-to-neck scheduling of activities, leaving less time to amend or redefine strategies when issues arise. This directly impacts the pace of trials. Recognizing these delays increases clinical and market risks, making early engagement a strategic necessity

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Are you in the early drug development stage and planning for early engagement with sites and investigators to accelerate your clinical trial process?

We can help you build early engagement strategies by involving investigators and sites from the start. This ensures your study design is practical, your recruitment plans are realistic, and your sites are well aligned, giving you a real advantage in the market.

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