The IDBS Preclinical Solution brings preclinical research data together in a single system, streamlining workflows and enabling collaboration. By integrating our solution with other lab equipment and systems, it serves multiple preclinical domains, including bioanalysis, pharmacology, drug metabolism, pharmacokinetics, safety, toxicology all the way into formulations and stability.
The preclinical space is growing fast – the volume of Phase I bioanalysis work in particular has almost doubled in the last ten years, and demand continues to increase. Driven by Phase I pipelines and large molecule studies, most bioanalytical work is now being contracted to CROs.
The increased number of samples sent for testing puts pressure on organizations, who have to work more efficiently and at a lower cost to meet demands and maintain competitive in the market. Every level of the process must be examined and deliberated over – the work accepted, personnel hired, equipment used, and techniques employed are all choices that have an impact.
As for the customer, there’s the process of selecting a CRO – the decision impacted by whether the choice is down to cost, speed of delivery, or an organization’s reputation. While the operating costs are lower in emerging markets, such as India and China, outsourcing overseas presents some challenges of its own.
Namely, CROs must align their methods with both international guideline requirements and the home market’s standards. Moreover, import rules, shipping and logistics will only become more stringent and competitive – while being mindful to keep costs down and tighten cycle time.
By identifying weak points in the chain, workflows can be streamlined, and business goals met. Getting the most out of existing processes means fixing points of highest burden including documentation, reporting, searching and retrieving data, and audit logs. An enormous amount of time is spent on these ineffective manual processes, which can be remedied using automated data capture and software to reduce errors throughout the whole process, enhance data quality, increase throughput, and cut the overall costs of operating.
All preclinical areas require sophisticated, scientifically-aware applications and data management. These capabilities need to be supported with sample management and deep integration capabilities to instrumentation and source data systems, coupled with strong statistical analysis support. The data produced needs to be useable by the generating domain for in-domain reporting.
But the data produced by a domain must also be consumable and useable by neighboring domains to ensure that the high impact, mission critical decision, aggregated cross domain data reports can be produced easily such as those required by PK/PD and in vitro/in vivo.
This is where the IDBS Preclinical Solution comes in. With its proven data model, structured data capture, curve fitting and statistical analysis and rich integration capabilities, it is the gold standard in preclinical data management and is trusted the world over by the world’s leading research and development companies.
Preclinical development encompasses several domains including pharmacology, drug metabolism, pharmacokinetics, bioanalysis, formulations and stability, toxicology, and safety. While each one comes under the preclinical umbrella, their diversity presents a challenge as each has specific requirements for data management and bioinformatics, which needs to adapt accordingly.
However, the data produced from each individual space is essential and needs to be reported to file an IND for new drugs as well as to achieve regulatory approval and maintain compliance. Considering this is time-sensitive, managing the data appropriately to remove bottlenecks should be a priority.
Because of this, it’s vital to capture and organize data from these disciplines in a prompt and efficient manner so that it can be accessed, shared, and applied without delay but without compromising on data integrity or quality.
It’s a two-pronged approach – (a) capturing and managing data with new and robust software so it can be utilized in current and future research, and (b) optimizing the lab and its numerous scientific tools and processes. To streamline workflows within the laboratory, it’s important to transform these two areas simultaneously and boost overall efficiency. Software can greatly improve processes while automated equipment and procedures optimize a lab, saving hours’ worth of time per experiment and adding business value.
Depending on the organization, different laboratories require distinct approaches for innovating software and modernizing technology. Each domain has its own specific requirements so implementing applications throughout the lab all at once can be complicated. There is more than one way to approach data management tool execution in the preclinical space – a simple step-by-step tactic could deliver business benefits quickly. Such an approach realizes incremental benefit while reducing risk.
For instance, pharmacology workflows are largely single point experiments, for which scientists would most likely use spreadsheet technology to collect, organize and manipulate the data. This is where a data management solution can effortlessly be introduced and can make a real difference – streamlining experiment reporting and speeding up regulatory processes to improve experiment timelines.
Importing data from lab devices and analyzing the data are the next stages that can be added to the tool kit. Also, automating data publishing between domains such as pharmacology and pharmacokinetics cuts the total study time and allows scientists to make data-based decisions with precision and confidence rapidly and impact businesses positively.
Effective approaches in a pharmacology R&D setting may not be the same as those desired in a contract bioanalysis laboratory, which operates to run, document and report on experiments at scale. The lab processes in bioanalysis and data manipulation, while narrow, are complex, and this is the case for many other domains in the preclinical area, where the organization needs more than conducting experiments and publishing reports on the study to reap benefits.
The key is to pinpoint where the company’s bottom-line will be primarily impacted and focus on those capabilities.
IDBS has been helping the world’s leading pharmaceutical and biotech companies for decades. The combination of industry-leading technology, world-class support and services and deep domain experience means we can work with our customers every step of the way and are able to deliver fully working solutions quickly and efficiently.
Our preclinical solution spans multiple disciplines in a single environment meaning companies can easily bring groups, and data, together into a single, fully integrated system without having to compromise on technology or functionality.
The IDBS Preclinical Solution combines more of your research data together in a single system, making the information available across your organization, speeding up collaboration and improving decision making.
You can find out more about how the IDBS Preclinical Solution can help your organization – whether customer or CRO – to increase efficiency, reduce errors and speed up cycle times here.
Watch this short video about Preclinical Software Solutions.
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