How Modern Software Can Advance Your Drug Development Pipeline

The Preclinical Phase of Drug Development

The U.S. pharmaceutical industry invested $83 billion in R&D in 2020. Developing drugs is an expensive and lengthy process. You can advance the drug development pipeline with the right preclinical software.

The preclinical phase is foundational in the phases of drug development. Preclinical studies show whether a drug is ready for clinical trials.

Learn more about how preclinical software can accelerate and improve drug development.

Challenges in the Preclinical Phase of Drug Development

The preclinical phase of the drug development process requires extensive studies. Trials can include:

Efficacy
Toxicology
Pharmacokinetics
Safety

As a result, preclinical research generates vast amounts of data. Collecting and aggregating this data efficiently is crucial. A variety of factors can make data management a challenge.

Multiple Teams Collaborating

The members of drug discovery and development teams often come from diverse backgrounds and approaches. Team members must learn to work effectively together. Sponsors and clinical research organizations (CROs) can have different data management processes.

Timeline Management

Managing the preclinical timeline can pose difficulties. You must compensate for unexpected events. Lost or misplaced data is a potential disruption.

Manual Data Collection

The preclinical phase often relies on manual data collection. Spreadsheets, text documents, email, and other paper documents are common.

The intention is always to transfer these records into digital format. However, retranscribing records increase the risk of error. It is time-consuming and labor-intensive.

Compliance with GLP and Other Standards

The nonclinical phase of the drug development process requires compliance with many regulatory standards. Following all the regulations requires careful oversight. In addition, you must create, store, and retrieve documentation related to each relevant standard.

For example, most preclinical animal studies must follow Good Laboratory Practices(GLP). GLP regulations help ensure the welfare and ethical treatment of study animals. They also help assure the reliability and integrity of preclinical data.

Facilitate Collecting and Analyzing Data with an Electronic Data Capture System

An electronic data capture (EDC) system provides a digital means for collecting, cleaning, and analyzing data from preclinical studies.

EDC solutions streamline data collection. Authorized personnel can access the EDC system from any computer in the lab. They can easily input data and make it available to reviewers.

Data managers can then review the data and work to resolve any discrepancies.

An EDC has advanced access management and data traceability features. You get a clear audit trail.

Sponsors, investigators, and auditors can efficiently review data in acentralized EDC system. An EDC gives you real-time insights.

Improve Lab Efficiency with a Laboratory Information Management System

A laboratory information management system(LIMS) helps you manage samples and the data associated with them more efficiently. A LIMS stores results and makes retrieving them easier. It automates routine, mundane tasks to improve efficiency.

Typical functionalities include:

Sample management
Inventory management
Data mining and analysis
Workflow management
Integration of electronic laboratory notebooks
Reporting

LIMS software helps you comply with regulations like GLP. It tracks the chain of custody. It records what lab personnel do and how they do it.

Enable Collaboration and Improve Process Efficiency with Electronic Lab Notebooks

An electronic laboratory notebook (ELN) is a digital version of the traditional lab notebook. It is a sophisticated software platform that lets you access, share, and analyze data. You can design and record:

Experimental protocols
Results
Research findings

An ELN can streamline the experimental process. For example, you can clone a previous experiment or use a template. You can automate workflows.

You can interface your lab equipment with the ELN. This improves productivity and makes more rapid analysis possible.

Information in an ELN system is securely available to stakeholders. Coordination and collaboration across groups and projects is easier. You can share data with defined access permissions.

Simplify Compliance and Data Management with an Enterprise Content Management System

An Enterprise Content Management System(ECM) is a software platform that provides tools to digitally manage your data.

An ECM provides a centralized repository for information. It helps you use your data to support processes and achieve your goals. It facilitates processes across departments.

A drug development company generates a huge amount of data. You have to store, manage, and use it in a way that meets regulatory standards.

An ECM makes all documents fully traceable. You can quickly provide information to compliance auditors when necessary.

Benefits of a Comprehensive Preclinical Software Solution for Drug Development

Several types of software systems are available to help advance your drug development pipeline. However, you will get the most benefits from a more comprehensive solution.

With individual software programs, your team needs to learn a different interface for each one. You have multiple vendors to interact with for upgrades or questions. You may still have problems with siloed data and a lack of transparency between systems.

An end-to-end solution gives you better control over the entire preclinical workflow. An integrated software ecosystem includes components like:

Electronic data capture
Laboratory information management
Electronic laboratory notebooks
Protocol management
Quality management
Enterprise content management

You have a gateway for process and information integration between sponsors and CROs. The right software can integrate the operating environments of preclinical R&D and CRO laboratories. Aligning your nonclinical workflows can significantly advance your drug development pipeline.

Choosing the Right Preclinical Software

The right preclinical software can advance your drug development cycle. It can streamline processes, improve efficiency, and make regulatory compliance easier. It can facilitate collaboration between the nonclinical R&D and CRO teams.

Pristima XD is a fully integrated digital laboratory execution system for the entire preclinical process. It can improve the efficiency of your lab processes by as much as 50% through automation. Better data management can reduce the time from end-of-study to final report transmission by up to 60%.

Project Management Services

Computer System Validation

Ready to learn more?

How Modern Software Can Advance Your Drug Development Pipeline

The Preclinical Phase of Drug Development

Challenges in the Preclinical Phase of Drug Development

Multiple Teams Collaborating

Timeline Management

Manual Data Collection

Compliance with GLP and Other Standards

Facilitate Collecting and Analyzing Data with an Electronic Data Capture System

Improve Lab Efficiency with a Laboratory Information Management System

Enable Collaboration and Improve Process Efficiency with Electronic Lab Notebooks

Simplify Compliance and Data Management with an Enterprise Content Management System

Benefits of a Comprehensive Preclinical Software Solution for Drug Development

Choosing the Right Preclinical Software

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