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Clinical Trial Process: 5 Ways to Eliminate Complexity

Learn five keys to clinical trial process improvement and get strategies to use automation to increase clinical trial efficiency.

Efficient and streamlined clinical trials play a crucial role in the timely development and delivery of life-saving treatments and vaccines. 

As the pharmaceutical and biotech industries continue to evolve rapidly, companies face the ongoing challenge of staying competitive by optimizing their operations and accelerating the process of bringing new treatments to market. By eliminating complexity in clinical trials, organizations can reduce costs, increase efficiency, and expedite the development of innovative therapies. 

Let's explore five strategies for streamlining the clinical trial process and how process automation can be a game-changer.

[ Want to learn more about how to accelerate clinical trials? Read the whitepaper. ]

5 keys to clinical trial process improvement.

1. Unify data.

Data needed in clinical trials is often scattered across disparate sources. By viewing data in a single pane of glass, teams gain timely access to relevant and accurate information. For example, if you want to understand why a decision was made early in the clinical trial process, it would be fastest to reference a single record of all project decisions. A data fabric can help with this, acting as an overlay that connects data across disparate systems and creates a unified view. This would eliminate reliance on emails and the need to navigate through various software solutions, speeding up your processes.

2. Enhance collaboration.

Many life sciences organizations still rely on outdated collaboration and communication systems, where tasks are received through email and remain stagnant in employees' inboxes for next action. To address this, implement a unified solution with real-time data capabilities for easier communication across global working sites. By automating manual communication channels and improving collaboration capabilities, organizations can quickly address tasks and keep the trial moving, leveraging real-time data with visibility for all stakeholders involved.

3. Streamline compliance activities.

Submitting for regulatory approvals takes time. Organizations must provide a large volume of documentation to demonstrate proof of adherence to the protocol as well as an audit trail of actions. To accelerate the compliance process, organizations should use modern tools to effectively track and report on trial progress and keep an updated repository of required documentation. Automated and on-demand process tracking offers continuous updates as well as the ability to tailor processes to comply with varying international regulations.

4. Simplify handoffs across teams.

Life sciences organizations frequently have to coordinate across internal teams and external contractors and vendors to execute a clinical trial. Being able to effectively share information and easily bring external organizations into internal workflows is critical for boosting the efficiency and effectiveness of the clinical trial. Intelligent automation can break down the barriers between teams’ data silos by bringing together technical disciplines that enable your organization to work faster and smarter.

5. Improve process visibility.

Gaining process visibility is crucial for identifying risks and addressing other potential bottlenecks across a clinical trial. To achieve this, bring all needed systems and processes together into a single, unified interface. Having a clear, streamlined workflow helps improve visibility and ultimately accelerates the entire clinical trial process. 

How automation improves clinical trial efficiency in 4 key ways.

Automation can improve the clinical trial process by eliminating obstacles, streamlining data transfers, and enhancing overall efficiency. By using a process automation platform, you can establish standardized workflows and automate traditionally manual tasks.

1. Study startup.

Automation capabilities can help streamline the many tedious tasks required at the start of a clinical trial. Pre-populate fields in documentation, automatically send and collect executed documents or application notifications to and from the right teams, and execute portions of the site startup process in the appropriate systems. Imagine automating the Form 1572 exchange with investigators or creating a site activation checklist that provides tasks for all required activities in accordance with the plan, avoiding users having to log into several different systems or maintain local trackers in Excel.

2. Regulatory submissions.

Effectively navigate the complexities of regulatory reporting. Process automation can help enforce important review and approval workflows with automated tasks and reminders and enable easier reporting with generated logs demonstrating actions taken throughout the process.

3. Data sharing and processing.

Enable more efficient and productive data sharing among internal and external teams working on clinical trials. Automation tools like robotic process automation (RPA) accelerate trails by letting you send timely communications, intelligent document processing (IDP) helps quickly process trial documents and forms, and business logic and rules help route and process decisions with little to no human interaction.

4. Risk management.

Leverage artificial intelligence (AI) and RPA to notify important stakeholders when one portion of the study is going out of bounds or if a risk threshold has been crossed. With advanced notification of potential risks, trial managers can quickly address and overcome roadblocks and get the clinical trial back on track faster.

While you can’t speed up the time needed to demonstrate the efficacy or safety of a drug, you can eliminate unnecessary slowdowns within the clinical trial process. By implementing a process automation platform that facilitates information handoffs, improves recordkeeping, and enhances data transparency, you can innovate across clinical trials and bring products to patients faster than ever before.

[ Learn how automation plays a major role in clinical trial management speed. Download the whitepaper: Accelerating Time to Market for Clinical Trials. ]