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Reducing Your Preclinical Regulatory Burden Through a Unified Solution


Challenges in Drug Discovery

Studies show the average cost of bringing a new drug to market is close to $1 trillion. Healthcare firms face a considerable regulatory environment and administrative burden. Professionals in the field note these items as key challenges to delivering effective products.

Organizations must comply with an ever-increasing and wide-ranging body of requirements. In many cases, these requirements are not well coordinated.

As a result, firms face significant obstacles in becoming more efficient. They also face the challenges of managing siloed functions. They struggle to improve the quality of their drug R&D workflows. A unified software solution can help organizations overcome these obstacles.

Keep reading to learn more about reducing your preclinical regulatory burden through a unified solution.

Framing Preclinical Regulatory Burden

In part, fragmented data sources cause a regulatory burden. Healthcare IT has changed medicine and clinical care dramatically. It’s given firms unprecedented access to information. However, technology still has not made the field of drug discovery easier.

Scientists and researchers know technology is the solution for accelerating the preclinical phase while improving care delivery. Yet, that same technology remains an ongoing source of frustration.

Many technologies introduce new challenges. Some even fail to address the existing challenges that they are supposed to improve.

Challenges of Compliance

Preclinical trials are critical in developing new medicines that ease the suffering of society. Today, firms must plan preclinical research for global acceptance.

However, they face challenges in this regard. These challenges include:

  • Cost computability
  • Improper study design
  • Lack of drug safety knowledge
  • Timeline
Furthermore, firms face mounting pressure from regulators. Regulatory agencies must adjust their focus on international and national regulations. They must consider the laws that govern how a firm will conduct pretrials.

Also, preclinical, and clinical research requires a significant budget. These combined influences make it incredibly challenging to conduct pre-trials.

The Benefits of Unified Solutions

Historically, firms have relied on on-premises informatics. On-premises systems have become outdated. What’s more, they’re inefficient and expensive. On-premises architecture requires considerable investment in several areas, such as:

  • Integrations
  • Internal IT staff
  • Servers
  • Software
  • Upgrades
These many costs add up quickly. You can reduce your preclinical regulatory burden by transforming your information architecture. Now, it cost much less for labs to host operations using a unified solution. A unified solution saves firms from purchasing separate software systems, managing upgrades, or overseeing complex cybersecurity.

Let’s look at a few more benefits of a unified solution.

Built-in Agility

Traditional lab informatics systems often have a fixed capacity. What’s more, they’re slow. Also, these systems are hard—if not impossible—to access outside of the lab. These limitations restrict your firm’s speed and agility.

With a unified solution, you can scale up or down as needed. You only need to use—and pay for—resources based on your demands and unique needs.

For instance, you can add a new lab user with just a few clicks using a unified solution. You can also access all the information and controls just as easily.

Boosting Lab Efficiency

Traditional informatics systems limit collaboration outside the lab. This makes it challenging to remain competitive. A unified solution supports accessibility and collaboration. It allows users and lab partners to access system data using various devices. Furthermore, they can do so both inside and outside the lab.

With a unified solution, your team can collaborate on projects and share information more easily. Furthermore, you can use a centralized database for your entire lab.

Keeping Your Data Secure

Today, every vertical has cybersecurity concerns. The research and development field are no exception. Labs must protect sensitive data from malicious actors. Hackers will go after any information that will enable them to make a profit.

Fortunately, you can use a unified solution from Xybion to encrypt your lab data. The solution can also provide excellent security for your backup systems. It can also provide you with an authentication system that only allows authorized users to access your information and even simplify your security audits.

Choosing a Unified Solution

Drug manufacturing, scientific R&D, and preclinical trials are complex projects. They require accurate data and critical analysis. Furthermore, some professionals in these fields must monitor their work around the clock. A unified solution for research management can help.

It’s vital to choose a unified solution that will help you to achieve optimum lab efficiency. You need one that will help you manage your lab and your facility more efficiently. Moreover, the right clinical lab solution will help you remain in compliance with various regulations.


A Unified Solution to Relieve Your Regulatory Burden

Many labs continue to operate using preclinical information that resides in numerous, disparate internal systems. They also source information from multiple external partners.

Unfortunately, they’re missing out in the absence of a unified solution. Their team members don’t have transparency for core business data. They are not able to make clear and informed decisions. Given these realities, preclinical lab leaders must integrate their new drug research and development capabilities with a total preclinical R&D management solution that unifies all the workflows.

Improve Your Lab Processes Now

You now know more about reducing the preclinical regulatory burden using a unified solution.

With Xybion’s Pristima XD solution, you can have a total preclinical research and development management platform that automates study processes and brings the entire company ecosystem under one unified digital platform with embedded quality and compliance.

Xybion Pristima XD is a unified solution for informatics and the full preclinical process. Our platform uses a central archive platform. Moreover, it helps you improve productivity and reduce costs.

Our clients have experienced a 50% efficiency gain with the reduction of manual processes. They have also enjoyed an average 60% reduction in time from end-of-study to final report transmission.

Discover how to bring products to market at rapid speed with a preclinical solution. Book a demo of Pristima XD today.
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