Navigating The Fast Lane: Five Strategies to Accelerate Clinical Trials

Clinical trial Sponsors are on a quest for practical tactics to boost efficiency and reduce cycle times. Discover five strategies Sponsors are leveraging to strategically speed-up trial timelines, with the aim to bring treatments to market faster.

1. Digital Health Technologies & Artificial Intelligence (AI)

Digital technology is pivotal in driving efficient clinical trials. Biotech and pharma companies are increasingly harnessing advanced technology, including cloud-based platforms, digital biomarkers, and AI-powered analytics. These innovations streamline data handling, reduce manual processes, and expedite trial activities. Moreover, technology provides a robust foundation for real-time collaboration and analysis, seamless communication across study phases, and efficient oversight of trial progress.

80% of clinical trials in 2022 used digital technologies—40% for patient adherence, 29% for patient retention, and 36% for non-patient-related processes.

2. Recruiting Today’s Digital Patient

Rapid enrollment of appropriate participants is imperative for clinical trial success. Sponsors are redefining trial designs to prioritize patient needs; considering preferences, lifestyles, and the integration of wearable technology. Additionally, targeted recruitment strategies, such as social media engagement and community involvement, are highly effective in swiftly identifying and enrolling eligible participants.

66% of executives outcomes and experiences rather than incentivizing based on the volume of services provided.

3. Streamlined Regulatory Processes

Regulatory approvals are often a bottleneck in clinical trials. Sponsors are now investing in strategies to streamline related design processes. Initiatives such as early engagement with regulatory authorities, clear communication, and meticulous preparation of submissions are gaining traction. By proactively addressing legal requirements, Sponsors can minimize delays and advance trials more efficiently.

This strategic approach involves continuous monitoring, staying updated on regulatory guidelines, and implementing adaptive strategies for compliance. Sponsors are increasingly adopting regulatory technology to automate specific processes, reducing the risk of errors and expediting approvals.

4. The Clinical Trial Management System (CTMS) Dilemma

Sponsors are either centralizing trial management or federating it. Centralized systems integrate trial components, including data management and site monitoring. A federated approach distributes responsibilities, potentially offering flexibility, but also risking fragmentation and inefficiency.

Efficient trial management is essential for timely execution. Sponsors are increasingly embracing the centralized CTMS for a unified view of trial progress to facilitate prompt issue identification and resolution, as well as for enhanced communication and reduced administrative burden.

Process linkages between the CTMS system and other support areas such as Regulatory Affairs & Clinical Trial Material Manufacturing bring desired efficiencies and improved accuracy. Moreover, Sponsors are exploring AI and ML (Machine Learning) to analyze extensive datasets and predict potential challenges before they arise; underscoring the role of technology in optimizing trial management for enhanced efficiency

5. Risk-Based Approaches to Vendor Qualification

To expedite clinical trials, Sponsors are adopting a nuanced, risk-based approach to vendor qualification. Currently, pharma and biotech organizations are engaging in redundant activities by qualifying the same Providers over and over again; often using different tools and criteria. To address this inefficiency, and duplication of efforts across the industry, Diligent Pharma has emerged as a crucial asset for Sponsors.

Diligent’s centralized platform can be used by Sponsors for discovering providers across the clinical trial service spectrum, conducting initial qualification by accessing and reviewing completed qualification questionnaires (RFIs), prioritizing providers based on their risk profile using Diligent’s proprietary risk scoring engine, and conducting deeper qualification through access to our body of completed vendor qualification assessment audit reports. Diligent’s centralized platform is a process innovation firmly rooted in the ICH Vendor Risk Management Framework, which advocates for utilizing a risk-based approach to vendor qualification. Diligent Pharma’s smart approach brings efficiencies and cycle time reductions to the clinical trial process.

More than $3 billion and 17 million days are wasted annually on redundant qualification activities.

Taking a Holistic Approach to Efficient Clinical Trials

Sponsors are embracing all of the above to accelerate studies; integrating digital technology, patient-centric trial design, regulatory tools, centralized trial management, and risk-based vendor qualification.

Schedule time to talk with Diligent Pharma. Our SME team would love to chat about the industry dynamics summarized here, and offer a point of view on what strategies can best support your team in accelerating trial start-up times.

Diligent Pharma is a tech-enabled quality and risk management organization focused on driving improvements in vendor qualification and management. Diligent offers a comprehensive offering that consists of:

• A secure technology platform that enables a seamless exchange of data and information;

• Subject matter expertise in regulatory compliance and quality management; and

• Data and information for driving decision-making around vendor selection and monitoring.

Diligent’s centralized approach drives efficiency while maintaining compliance rigor, data integrity, and high quality; marking a transformative shift toward streamlined and robust risk-based vendor qualification in clinical trials.