Unlocking Clinical Trial Efficiency: Embracing Digital Solutions

Clinical trials can be both costly and time consuming, but there are solutions that can help lower costs and create efficiencies. This article provides insights and tips that are sure to help you overcome some of the obstacles keeping you from optimizing your clinical trials.

If you work for a life sciences company specializing in the development of new drugs and therapeutic biological products, then you are probably aware that costs associated with clinical trials have skyrocketed. In fact, according to a 2018 study published in JAMA Internal Medicine, they have increased by nearly 100 percent over the last 10 years.

Clinical trials alone now cost life science companies, on average, anywhere from $12.2 million to $33.1 million. One of the biggest reasons for the rise in cost has to do with optimizing how the trial is conducted and the resources used to execute it.

The good news is, technologies are available today that can help pharmaceutical developers save significant time and money, while also improving processes and workflows. However, CIOs need to look beyond traditional clinical applications and work to implement digital solutions developed specifically for clinical trials, but that also keep the entire enterprise in mind. The reason for this is simple; traditional technologies are somewhat siloed and do not always stretch across research department boundaries. For organizations focused on agile methodologies, this old way of managing clinical trials makes no sense.

The Importance of Clinical Trials

Clinical trials serve as the lifeblood of the pharmaceutical industry, playing a pivotal role in drug development, regulatory approval, and ultimately, the well-being of patients worldwide. Their significance cannot be overstated.

Drug Development: Clinical trials are the crucible where new drugs and therapeutic biological products are rigorously tested. They help determine a drug's safety, efficacy, and optimal dosages, paving the way for innovative treatments.

Regulatory Approval: Regulatory bodies, such as the FDA in the United States, require extensive clinical trial data to assess a drug's safety and effectiveness before granting approval. Without robust trials, promising therapies would remain inaccessible.

Patient Care: Clinical trials offer hope to patients with limited treatment options. Participation in trials can provide access to cutting-edge therapies that might otherwise be unavailable.

Advancing Medical Knowledge: Trials generate invaluable data that contributes to our understanding of diseases and treatment strategies. This knowledge benefits not only current patients but also future generations.

Economic Impact: Clinical trials drive economic growth by fostering innovation and supporting numerous jobs in the pharmaceutical and healthcare sectors.

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Challenges in Clinical Trials: Navigating the Complex Landscape

Clinical trials are the bedrock of medical progress, but they are not without their hurdles. Life sciences companies grapple with various challenges when conducting clinical trials. The main difficulties revolve around price and time limitations, affecting medicine progression and patient availability to groundbreaking therapies.

Cost Constraints: Clinical trials are expensive endeavors. According to a study published in JAMA Internal Medicine, the costs have surged by nearly 100% over the last decade. On average, life sciences companies now invest between $12.2 million to $33.1 million per trial. These exorbitant costs encompass various factors, including research, patient recruitment, and compliance with stringent regulatory requirements.

Time Constraints: Time is of the essence in drug development. Clinical trials often stretch over years, and any delays can hinder patients' access to potentially life-saving therapies. Lengthy trials also drive-up costs, compounding the financial burden on companies and patients.

The reasons organizations get stuck using outdated methods are varied, but often include one or more of the following:

• The organization is tunnel-visioned on departmental efficiencies, ignoring the benefits of big picture trial optimization and cycle time acceleration.

• The IT department is locked into the habit of incremental solutions upgrades, because they feel this reduces risk of disrupting operations. IT has been given no incentive to take risks on digital transformative solutions.

• The organization passed over clinical operations technologies in their search for enterprise-wide technology upgrades.

• The organization views any new expense as a negative, and site operations and related expenses already account for too much of the trial’s cost. Meaning; clinical operations are on the front lines of the battle against trial costs.

Optimizing Clinical Trials with Technology Solutions

In the realm of clinical trials, technology solutions have emerged as crucial assets in boosting efficiency and precision. Clinical Trial Management Software (CTMS) plays a pivotal role in this transformation. CTMS platforms like Medidata, Oracle's Siebel CTMS, and Veeva Systems streamline the intricate processes of Clinical Trial Management. They facilitate real-time data tracking, participant management, and seamless collaboration among research teams.

Moreover, Electronic Data Capture (EDC) systems such as REDCap and OpenClinica enhance data collection accuracy, reducing errors and ensuring compliance. These innovations effectively tackle the challenges of data overload and regulatory hurdles, resulting in accelerated trials and improved outcomes. Organizations like Pfizer and Novartis have successfully leveraged these technologies, demonstrating their potential to revolutionize clinical trials.

Unlocking Clinical Trial Efficiency with Clinical Trials Management Software

Digital tools are pivotal in the realm of clinical trials, offering numerous benefits. Clinical Trial Management Software (CTMS) streamlines trial operations, reducing costs and saving valuable time. It enables seamless collaboration among research teams and provides real-time data insights. Electronic Data Capture (EDC) tools enhance accuracy, accelerating data collection and analysis, ultimately expediting trials.

The truth of the matter, though, is that technological innovation should be a continuous, ongoing endeavor within clinical development. Increasing efficiencies and optimizing processes is the key to driving down costs, and it can only be accomplished with technologies that are focused on clinical trials and that are compatible with enterprise-wide workflows. These types of solutions help clinical operations teams optimize their trial processes by eliminating unnecessary steps, better allocating resources and prioritizing critical activities across departments.

Digital tools, such as P360's Curotrak, help life sciences companies bring different departments together for clinical trials. And data management tools like BirdzAi to integrate siloed systems by making critical clinical data more visible across the enterprise. Solutions like these enable clinical teams to improve trial performance, supporting data-driven approaches that once seemed impossible.

Although digital tools often require an initial time and money investment, the dividends become clear in a short amount of time as the organization is able to better manage and utilize trial data. Improvements in data quality, for example, may not save time and cost for the department that crunches the data. It may require more time and processing. However, the benefits will compound as the data moves through the organization with fewer quality checks, inputs, and cross-checks.

This data efficiency leads to improved clinical processes, including trial operations, site monitoring, data management, trial planning and feasibility. The ripple effects often continue well after specific trials are over, as teams find more ways of leveraging the data.

To better understand the benefits of implementing new digital tools, one must first understand the pieces of the clinical trial puzzle they help optimize. For example, Curotrak offers a clinical trial management system, enabling faster site selection and startup, enrollment, execution and tracking. Another important aspect of tools like Curotrak is that they integrate with existing systems, helping to reduce downtime while ensuring a seamless flow of information across operations. Technological tools can help to support multiple studies across various sites, while safeguarding clinical trial processes and data.

Cost-benefit analysis of digital tools in clinical trials

When it comes to clinical trials, the adoption of digital tools such as clinical trial management software (CTMS) and electronic data capture (EDC) systems is more than just a technological advance – it is a strategic investment is a very profitable business in the long run.

Initially, integrating these digital solutions comes with software licensing, training and implementation costs. However, the return on investment (ROI) is high. CTMS increases test management efficiency, reduces administrative costs, and ensures compliance, thereby reducing administrative costs. EDC systems streamline data collection and validation, reducing costly errors and delays.

Revolutionizing patient recruitment in clinical trials with digital solutions

Digital solutions are transforming patient recruitment in clinical trials, optimizing procedures in previously unimaginable ways. Clinical trial management software (CTMS) and data analytics play a key role in this transformation.

CTMS simplifies trial management, allowing for rapid identification and onboarding of qualified participants. Data analysis filters large databases of patients, identifying potential clients more effectively. Multiple marketing strategies target specific populations and patient communities, extending the coverage of trials far and wide.

Enhancing clinical trial site management and communication with clinical trial site management software

Clinical trial site management can be a complex and time-consuming process. Digital tools such as clinical trial management software (CTMS) and Internet of Things (IoT)-powered devices are transforming this field in clinical trials, solving key challenges and improving efficiency

Curotrak and other CTMS platforms provide centralized control over site operations, facilitating site startup and ongoing management. They facilitate real-time communication and data sharing between facilities and sponsors, reducing delays and errors.

IoT-enabled devices, such as remote monitoring devices, enhance data collection and patient monitoring, reducing the need for on-site visits Not that this provides temptation is not only faster but also reduces costs.

Elevating Clinical Trials with Data Platforms and Reporting Tools

In the dynamic landscape of clinical trials, data management and reporting are critical for success. Data platforms like BirdzAI have emerged as game-changers, revolutionizing clinical trial management and reporting.

BirdzAI serves as a centralized hub, seamlessly integrating with Clinical Trial Management Software (CTMS) and other enterprise-level systems. These platforms offer smart reports and mapping tools that provide real-time insights into trial progress and data quality. They enable efficient data collection, storage, and analysis, minimizing errors and enhancing decision-making.

With that in mind, as you work to find solutions that will enable your organization to improve clinical trials, lower costs and increase efficiencies, there are some key questions you should ask. Here are a few:

Will it help expedite patient recruitment?

Patient recruitment for clinical trials is a evolving function for digital solutions focused on clinical trials. Thanks to multichannel marketing, data analytics, natural language processing and patient communities, there is an increased availability of data for these tools to utilize. And products like BirdzAI can be used to help provide insight into where trial subjects can be found, helping teams maximize trial participant enrollment.

Can it optimize site management and communication?

Clinical operations leads understand that that there are many challenges associated with site startup. As a result of the myriad of paper processes that surround the investigator sites, life science companies have long struggled to streamline site startup and communication. However, when you couple BirdzAI with Curotrak and our IoT powered-Swittons-devices, you get a powerful platform for both managing trials and automating remote communication between once siloed offices and systems.

Will it improve management of trial resources?

Life science organizations often overlook forecasting and planning technologies, opting instead for spreadsheets. But new tools have emerged, like Curotrak, which help improve study forecasting, study planning and management, and portfolio analytics. And they offer a smart, user-friendly interface that beats fumbling with spreadsheets any day.

Does it include a clinical data repository?

New data platforms like BirdzAI provide smart reports and mapping tools for clinical development. Built to integrate with other enterprise level systems and solutions, these data warehouses enable out-of-the-box dashboards that are made for clinical use cases. These digital systems are easy to deploy and can be custom configured for specific workflows.

If your answer is no to any of the important questions above, then your investment in that solution should be reconsidered. Look instead for a solution like Curotrak, which works across multiple departments and integrates easily with existing systems and processes. All P360’s solutionsare built with an agile, omnichannel mindset. This ensures that all of your important clinical trial data is assimilated across the entire enterprise, and not trapped in departmental silos.

As your organization evaluates solutions for transforming clinical trials, we hope this guide helps lead you to the perfect place.