Preclinical contract research organizations (CROs) play a vital role in drug development. They perform specialized studies that pharmaceutical and biotech companies depend on to advance new therapies. Demand for CRO services is soaring, and market forecasts suggest that the global preclinical CRO industry will grow from about $7.1 billion in 2023 to more than $11.3 billion by 2030.

With this rapid growth comes heightened pressure. CRO executives and lab directors must navigate complex new drug modalities, stringent regulatory oversight, and increasing client demands for speed, accuracy, and data transparency. The challenge: How can CROs scale operations effectively while maintaining quality and compliance? Many still rely on outdated methods, juggling paper notebooks, spreadsheets, and fragmented systems, making efficiency and data integrity difficult to achieve.

This shift represents a pivotal moment for the industry: adopt digital workflows or risk falling behind. This article explores why digitization is no longer an option but a necessity for CROs, particularly preclinical CROs, detailing industry trends, real-world case studies, and actionable steps for leaders looking to future-proof their operations.

The Urgency of Going Digital in Preclinical Research

The life sciences sector is undergoing a profound digital transformation across R&D, manufacturing, and regulatory compliance. A recent survey revealed that 74% of biopharma companies are migrating their scientific data to the cloud to enhance scalability, resilience, and speed to market. Yet, in traditional laboratories, nearly half (49%) of a scientist’s time is spent on manual data handling—retrieving, cleaning, and organizing datasets—activities that automation could significantly reduce.

Preclinical CROs, as essential partners in drug development, are expected to keep pace with these changes. Clients now demand real-time access to research data, seamless collaboration, and expedited project execution. Regulatory bodies are also reinforcing digital compliance mandates. For example, the NIH now requires all intramural researchers to use electronic lab notebooks (ELNs) to boost collaboration, data security, and traceability.

The COVID-19 pandemic further accelerated digital adoption, fast-tracking automation and data management initiatives across the life sciences industry. This transformation sends a clear message: the opportunity for 'going digital' is now.

CRO leaders increasingly understand that digitization isn't merely an IT upgrade—it’s a strategic necessity. As one industry expert aptly stated, “In the competitive and highly regulated environment of life sciences, digital transformation is vital for optimizing operations, driving efficiency, and ensuring compliance.”

A Boston-based synthetic protein/peptide AI team experienced data silos and inefficiencies due to a lack of integration between their wet and dry lab teams. Integrating Scispot OS led to a 40% reduction in request creation time, a threefold increase in scientific productivity, and improved data management across bio-manufacturing, proteomics, and bioinformatics teams.

Efficiency and Productivity Gains

One of the most compelling reasons for CROs to digitize is the significant boost in operational efficiency. Digital workflow platforms and modern electronic lab notebook (ELN) alternatives, such as Scispot's Lab Operating System (LabOS), streamline data capture, automate routine tasks, and integrate previously fragmented processes. The impact on productivity can be transformative.

For instance, a study on ELN adoption revealed that researchers saved an average of nine hours per week by switching from paper-based systems. Some users recouped as much as 17 hours weekly—equivalent to two full working days—by reducing time spent on manual reporting, scheduling, and email coordination.

These gains improve lab productivity and shorten project timelines. Faster study completion allows CROs to take on additional projects, meet client deadlines more efficiently, and generate greater revenue.

Beyond time savings, centralized digital data management accelerates drug development by enabling instant access to experiment data, protocols, and results. Instead of spending hours retrieving scattered files, researchers can analyze data in seconds. As noted in BioPharm International, well-designed digital systems for preclinical data collection and organization can “significantly advance progress in drug discovery and development,” ultimately expediting the path to patients.

Automation further amplifies these benefits. WuXi Biologics, one of the world's leading CRO/CDMO companies, reported that automation and digitalization shortened their research timelines by months. By integrating digital tools with robotics, WuXi significantly increased the throughput of traditional assays like ELISAs and cell sorting, allowing them to screen a greater number of drug candidates simultaneously. This approach not only accelerates the identification of viable compounds but also increases the likelihood of success by broadening the experimental scope.

A fully digitized lab functions at a whole new level, transforming operational bottlenecks into competitive advantages. Preclinical CROs that adopt digital workflows can significantly enhance efficiency, compliance, and data accuracy—ultimately establishing themselves as preferred research partners in an increasingly data-driven industry.

Enhancing Data Integrity and Compliance

Data quality is not merely a technical detail in preclinical research; it is the backbone of regulatory compliance and business success. CROs must ensure that every dataset, lab note, and report can withstand rigorous audits and sponsor due diligence. However, paper-based processes and fragmented systems create compliance risks, making it difficult to enforce standards, track every change, and prevent human errors.

Digital platforms like LabOS eliminate these vulnerabilities. Features such as automatic audit trails, time-stamped electronic signatures, and controlled user access ensure compliance with Good Laboratory Practice (GLP) and 21 CFR Part 11 data integrity requirements. This is not merely theoretical; the FDA has penalized CROs for data integrity failures that have invalidated entire studies.

A preclinical CRO in New Jersey recently transitioned to a modern ELN (Scispot alt-ELN) to enhance project documentation, and the results were dramatic:

• 3× improvement in data quality

• 100% regulatory compliance

• 50% reduction in labor hours through workflow automation

Digitization prevents compliance disasters and enhances everyday quality. Standardized electronic forms and validation rules eliminate missing data and errors at the source. When auditors or clients request information, digital systems can retrieve traceability records instantly—no more searching through file cabinets.

Collaboration improves as well. Secure web portals and cloud-based ELNs enable CROs to share data with sponsors in real time, rather than relying on large email attachments or USB drives. Ultimately, a well-implemented digital system fosters trust, helping CROs secure repeat business while aligning with regulators' growing preference for electronic data management. The message is clear: to scale efficiently and maintain compliance, preclinical CROs must adopt digital solutions.

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Financial ROI and Competitive Advantage

For CRO executives, any significant operational change must deliver business value. Fortunately, the ROI of digital transformation is well-documented. The most direct impact comes from efficiency gains—time saved translates into lower personnel costs and increased project capacity.

A study on LabOS adoption found that after a brief learning curve, most labs recouped their investment within just 2–3 months. Eliminating redundant data entry, automating reports, and reducing errors all contribute to considerable cost savings. Going paperless also removes expenses related to physical storage, printing, and document archiving—non-trivial costs for document-heavy GLP toxicology studies.

Beyond cost savings, digitization provides a competitive edge. In a CRO market growing at approximately 7% annually, clients have choices. Sponsors prioritize CROs that can deliver faster results, ensure higher data integrity, and provide real-time study tracking. Digital maturity becomes a selling point. Many CROs report that an integrated digital platform helps them secure more contracts—sponsors trust operations that run on streamlined, high-tech systems rather than a patchwork of spreadsheets.

This trend is clear: Hundreds of CROs have adopted Scispot’s lab automation platform to accelerate research and improve data quality. Faster turnaround times and reliable data drive higher client satisfaction, repeat business, and positive word-of-mouth.

Moreover, a digital CRO is better positioned for the future. It can scale services, integrate AI-driven data analysis, and adapt to evolving regulations with ease. All these factors contribute to a strong ROI and long-term business resilience. Simply put, digitization enables CROs to achieve more with less—and do it better—directly impacting the bottom line positively way.

An RNA therapeutics startup faced challenges with a rigid in-house bioinformatics platform and cumbersome manual data workflows. By adopting Scispot's scalable data processing solutions, they achieved a 50% faster turnaround for data analysis, a 75% reduction in manual data handling, and a threefold increase in SPR data processed.

Real-World Transformations: CROs Leading the Digital Shift

The move to a digital lab may seem abstract until you see it in action. Across the industry, forward-thinking CROs are modernizing their workflows, and the results speak for themselves. Here are real-world examples of how digitization is transforming operations.

A preclinical CRO specializing in pharmacology studies struggled with paper-based documentation and the constant stress of regulatory inspections. Implementing an alternative ELN with automated data capture cut labor hours by half, ensured complete compliance, and made audits effortless. Scientists also saw a threefold improvement in metadata capture, significantly enhancing data integrity. The lab director noted that preparing for audits went from a fire drill to a routine process, all because every record was digitized, organized, and instantly searchable. This case highlights how the right technology can improve efficiency and compliance simultaneously.

A mass spectrometry-focused CRO faced challenges with inconsistent workflows and variability in experiment execution. By introducing digital workflow templates and automation, the company streamlined its processes, reducing variability and significantly speeding up staff training. Every experiment followed a standardized digital playbook, ensuring consistency across projects and increasing client confidence in the reproducibility of their data. This shift enabled them to scale their services while maintaining high-quality standards.

Culture Biosciences, a company offering bioreactor-as-a-service, integrated a digital lab platform and immediately saw results. According to Satshabad Khalsa, Engineering Manager at Culture, Scispot was easy to integrate into their system. Pre-configured workflows for inventory tracking, media preparation, and protocol execution streamlined operations and elevated quality standards. By automating data tracking, Culture-reduced errors and improved reproducibility, two key metrics for any CRO delivering lab services.

Large CROs like WuXi AppTec have heavily invested in automation and AI-driven analytics to increase assay throughput and optimize protocols. With cloud-based data mining, they can now identify toxicity risks before running an assay—a capability that was impossible with paper-based records. This shift highlights a growing competitive gap. CROs that harness their data gain a significant advantage, while those that don’t risk falling behind.

From mid-sized niche CROs to global players, one thing is clear: digital adoption is redefining industry standards. Whether through faster workflows, standardized processes, improved data integrity, or AI-powered insights, CROs that embrace modern tools are leading the way.

Actionable Strategies for Embracing Digital Workflows

For CRO leaders who understand why digital transformation is necessary, the next question is how to implement it effectively. Here’s a step-by-step strategy to transition to digital workflows without disrupting operations.

The first step is to define a clear digital vision. The primary goal may be to handle more studies, improve data integrity, or provide real-time client access. Aligning digitization with business strategy and existing pain points, such as compliance risks or slow reporting, ensures a successful transition.

Securing leadership and team buy-in is equally important. Digital transformation is as much about people as it is about technology. Leaders should communicate the benefits to staff, identify change champions who can advocate for the transition, and address common concerns such as the learning curve or operational disruption. Many transformations fail because organizations focus on technology but neglect the human element. As one MIT expert noted, “we focus too much on digital and not enough on transformation—it’s a leadership challenge, not just a tech one.”

Instead of overhauling everything at once, starting small with high-impact projects ensures a smoother transition. A pilot project in a specific area, such as implementing an ELN in one department or automating sample tracking in a single study, allows teams to see quick benefits. Early success builds confidence and momentum for broader adoption.

Choosing the right digital platform is critical. The ideal solution should be flexible, scalable, and designed for scientific operations. Key features include integration with instruments, LIMS, and CRM systems, built-in compliance measures like audit trails and electronic signatures, and configurability to adapt to unique assays and SOPs. Many CROs opt for an all-in-one lab management platform that serves as a digital backbone, unifying data from research, operations, and business functions. For instance, Scispot’s Lab Operating System is a unified platform that combines essential features of ELN, LIMS, inventory management, and automation into a single interface. Involving end users in the selection and trial process is crucial for adoption, as their support determines the success of the transition.

Investing in training and updating standard operating procedures ensures that employees are comfortable using the new system. A structured training program helps scientists and staff understand digital workflows, while updated SOPs reinforce best practices. Instead of a one-time training session, companies should establish ongoing training and a “train the trainer” model, where super-users guide their colleagues. Support during the transition period is crucial to overcoming resistance and ensuring smooth adoption.

Migrating data thoughtfully prevents disruptions. Not all historical data needs to be digitized immediately. Ongoing study records should be transferred to the new system, while older data can be archived. Using APIs or import tools helps move data in bulk, ensuring scientists are not left searching through file cabinets for missing information.

Measuring progress with key performance indicators is essential for tracking success. Metrics such as cycle time, error rates, customer satisfaction scores, and compliance audit results provide a clear picture of the impact of digital transformation. Many digital platforms offer built-in analytics, making it easy to monitor these KPIs in real-time. Before-and-after comparisons demonstrate efficiency gains, such as faster study completion times or reduced documentation errors. Sharing these results with staff and clients reinforces the value of the transition.

Digital transformation is not a one-time project but an ongoing process. Continuous feedback from users helps refine workflows, while new capabilities such as AI analytics or IoT device integration can further enhance operations. As organizations gain confidence in digital systems, they can extend digitization across departments and explore new application areas. A CRO that fully embraces digital workflows will be more agile, scalable, and prepared for future industry shifts.

By combining technology with effective change management, preclinical CROs can increase efficiency, improve compliance, and gain a competitive edge. The return on investment is clear: faster operations, better data, and a business ready to scale. The future of CROs is digital, and those who adapt now will lead the industry tomorrow.

Conclusion: Embracing the Future of CRO Operations

Preclinical CROs are at a turning point. The demand for faster, higher-quality research presents both a significant opportunity and a clear mandate to evolve. Digital transformation is no longer merely a technological upgrade—it’s a strategic necessity. Modernizing lab workflows enables CROs to shorten project timelines, eliminate transcription errors, and navigate regulatory audits with confidence. The most successful CROs today are those that have invested in data-driven infrastructure, establishing new benchmarks for efficiency and reliability. Their achievements are shifting industry expectations, making digital adoption not just a competitive advantage but an operational baseline.

For those still contemplating the shift, the message is clear: transformation does not have to be overwhelming, and even small changes can yield significant results. Learning from successful case studies provides a roadmap, while understanding the pitfalls of poorly executed implementations serves as a cautionary guide. True digital transformation requires more than just new software—it demands leadership, a clear vision, and an organizational culture that embraces change. Although studies indicate that only about 16% of digital transformations succeed, preclinical CROs that adopt a methodical approach can position themselves among the winners.

Looking ahead, the future of preclinical research will be shaped by AI-assisted experiment design, real-time data exchange between sponsors and CROs, and fully automated laboratories. The efforts made today to digitize workflows are laying the groundwork for these advancements. By building a robust digital infrastructure now, CROs ensure they are prepared to integrate future innovations seamlessly. Going digital is not just about enhancing operations in the present—it’s about future-proofing the organization for whatever scientific and regulatory changes lie ahead.

Now is the time to act. Digital transformation is not just a passing trend; it has become the new standard for operational excellence. CROs that embrace it will not only experience immediate efficiency gains but will also enhance their market position for years ahead. In an industry focused on accelerating life-changing treatments, optimizing research workflows through digitization benefits both CROs and their clients. Taking the next step—whether it’s adopting an integrated lab management platform, automating reporting, or training teams on a digital ELN—brings organizations closer to a more efficient and resilient future.

Next Steps

Evaluate your lab’s digital gaps, consider solutions that meet your needs, and connect with technology providers who specialize in modern lab workflows. Request demonstrations, gather insights from industry leaders who have made the transition, and take the first steps toward a smarter, faster, and more scalable preclinical operation. The CROs that act decisively today will set the pace for the industry tomorrow.

Take the Next Step with Scispot

Scispot’s Lab Operating System (LabOS) is built for CROs looking to:
Automate workflows to reduce errors and speed up studies
Centralize data for seamless collaboration and real-time insights
Enhance compliance with built-in audit trails, ELN, and 21 CFR Part 11 features

See how Scispot helps leading CROs streamline research. Book a demo today: scispot.com/demo

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