Staying Connected and Compliant: Reimagining Clinical Trials with Longboat

Few technologies have radically changed the way we do business as electronic workflows. Today, projects can be edited by multiple people in real time, and the latest information is available on any device with an internet connection. The change has happened so fast and seamlessly, the youngest generation of adults have had a completely different workplace experience than those only a decade older. The time saved, mistakes avoided, and better decisions made because of this technological capability is incalculable.

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience.

Nowhere is this more painful than in clinical trials, the backbone of drug development. These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators. Everyone may use different software systems to manage these documents. Any mistake in collecting, collating, and analyzing these data could mean months of delays and potentially millions of dollars lost – not to mention delays in delivering new therapies to patients.

To bring clinical trials into the modern era, Advarra offers Longboat, a centralized hub designed to guide and connect all stakeholders, enabling real-time collaboration and streamlining critical workflows. Here are some areas where Longboat assists in managing clinical trials, along with how each process is typically managed and how Longboat’s approach differs:

Document Collection and Management

• Typical process: Documents stored in generic document storage software is exchanged manually by email, often leading to duplicate requests and potential errors when managing multiple versions of a document.
• Longboat’s approach: Longboat is a single hub where all required documents can be accessed, monitored, and distributed. This helps prevent duplicate documents and version control, ultimately enhancing visibility and audit readiness while reducing redundant communications.

Regulatory Compliance and Submission

• Typical process: Submissions to regulatory bodies usually require manual compilation of documents and individual submissions to each agency.
• Longboat’s approach: The platform integrates with regulatory and institutional review board (IRB) systems, streamlining submissions and ensuring regulatory documents are automatically routed to long term storage destinations to maintain audit readiness and regulatory compliance.

Recruitment and Enrollment

• Typical process: Recruiting patients for clinical trials is challenging – more than 80% of trials fail to enroll on time. Enrolling patients typically involves entering information into multiple systems and manual management of potential participants from various sources, which can be cumbersome and inefficient.
• Longboat’s approach: Longboat consolidates referral leads into a single system, even automatically directing patients to the nearest study site geographically, simplifying the process and integrating leads from various recruitment firms.

Study Training and Site Compliance

• Typical process: To make sure patients and medical staff understand the steps and requirements of the clinical trial, sponsors provide training. However, it is often unengaging, cumbersome, and manual. Sponsors lack visibility into training activity, and sites are left to navigate complex procedures with subpar, difficult-to-search resources ahead of patient visits.
• Longboat’s approach: Longboat’s interactive training modules can be developed and deployed rapidly in one system, ensuring seamless site onboarding and access throughout the (sometimes years-long) duration of a trial. This also improves engagement and understanding among site staff and simplifies the process of staying updated with training requirements and routing training certificates to proper systems for long term storage and audit preparedness.

Visibility and Communication

• Typical process: Visibility across different stages of the trial is often limited, requiring multiple systems and manual updates, or reliance on in-house reporting teams can become a bottleneck for visibility and report generation.
• Longboat’s approach: Longboat offers shared visibility and a collaborative portal designed to simplify both communication and document sharing, making it easy for all parties involved to stay informed without frequent direct inquiries. Study members can also take action within the same system, and provide essential context for sites on specific issues or actions to take.

Longboat’s technology significantly streamlines various aspects of clinical trial management by integrating multiple functionalities into a single platform, thereby enhancing efficiency, reducing manual work and compliance risks, and improving the quality of trials.

What’s the real-world impact of these improvements? A better trial experience for everyone. Sites using Longboat are 27% more likely to hit recruitment targets; report 21% fewer deviations; and require 60% fewer logins that are critical for clinical trial site workflows.

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