It’s Time to Build a More Scalable, Connected CRO

While scientific excellence within contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) is crucial, it’s now a commodity.

Competition is now operational. Margins are increasingly tied to efficiency; manual steps and disconnected systems directly impact cost and delivery.

CROs must deliver results faster at the highest levels of quality, accuracy, and repeatability at the lowest possible operating costs, all while elevating the client experience. CROs need fully predictable processes, moving samples through the lab efficiently and delivering data quickly. The CROs that can scale volume while simultaneously increasing speed without compromising quality are the ones that stand out.

Clients want to be secure in the knowledge that timelines will be met, with consistent outcomes, and full transparency and reporting. Clients want to understand what's happening with their samples and studies without having to chase the CRO for updates.

Long-term CRO success requires a focus on strengthening the following three operational aspects and building an organization that is fast, reliable, and trusted:

• Efficiency and automation, which encompasses speed and scale. It’s about how quickly the CRO can move samples, execute workflows, and deliver results without increasing risk. Manual steps, disparate spreadsheets, and workarounds work at low volumes, but they quickly become bottlenecks as demand grows.
• Data integrity and compliance must be a given. Clients and regulators primarily care about whether data are complete, accurate, traceable, and trustworthy, with integrity and authenticity.¹This translates into standardized workflows, structured data captured at the source, and built-in readiness for audits and inspections.
• Client experience has become a key differentiator. Clients are demanding more real-time visibility into what is happening. The CRO needs to proactively communicate with the client, keeping them abreast of all activities. It should not fall to the client to request status updates.

The catalyst driving lab digitization is simple: the CRO has outgrown spreadsheets and homegrown systems, and execution is difficult to manage. Furthermore, the dependency on manual operations has increased risks in compliance, auditability, traceability, and repeatability of experimentation.

Embracing Efficiency and Automation

The larger the CRO, the more manual processes and workflows cause significant bottlenecks and errors. Every time a sample comes in, is stored, moved, or processed, it needs to be tracked. The process needs to work just as well for 10,000 samples as for 10.

The key is going from survival mode operations to operations built to scale. In survival mode, samples are tracked by hand, inventory systems work fine until volume increases, and information is passed around in different files and emails. The result is reactive work.

Automation reduces the effort per sample. An organization operating at scale has standardized, automated workflows with no compromise in data quality, so the system can handle volume spikes. Their technologies are designed for growth; systems are connected end-to-end; and teams have real-time visibility into what is happening.

Strengthening Data Integrity and Compliance

As a CRO grows, data becomes more complex, with ever-increasing volumes. More studies are done; results need to be communicated to more clients; and all activities must comply with the latest regulatory requirements.

The adoption and application of FAIR principles: findable, accessible, interoperable, and reusable, can add value to CROs in the management of their clients’ data.² If data are not structured properly from the beginning, management is a major challenge, especially if it’s siloed among hardware and software. With the volume of data generated by individual AI tools, data management becomes an even greater bottleneck. Properly managed data integrity results in standardized experimental design and protocols with structured, machine-readable results.

Once data management is out of the way, end-to-end sample traceability must be addressed. CROs need to know exactly where every sample has been, what has been done to it, and by whom. Barcoded samples combined with a comprehensive sample management system can be used to ensure this happens.

Everything needs to support built-in regulatory readiness. Instead of scrambling for audits or inspections, compliance is a natural outcome of well-designed workflows and connected systems.

Driving the Client Experience Toward Excellence

A strong client experience is a competitive advantage. When the CRO delivers clients visibility, transparency, and predictable delivery, client confidence increases significantly. Creating the infrastructure to be able to fulfill those requirements takes a measured approach.

In many CROs, this is how it works today: requests come in by email, phone, or chat. They ask:

• Did you get my samples?
• What's the status?
• Where are my results?

Clients don't just want results; they want confidence in how those results were generated, stored, and reused. If systems don't talk to each other, information is scattered. No single place connects customers and the lab through the entire process. Every step becomes a bottleneck in the communications process. Clients must constantly ask for updates as each team is handling a different aspect of the project, and no one can give them the big picture. All this creates extra work that adds no scientific value but does significantly add time and expense.

The goal is to create a seamless, transparent partnership with clients. Instead of tens of messages back and forth and the time spent tracking everything from both sides, the ideal is a single two-way communications channel, with secure, segregated access providing real-time visibility into sample status, inventory availability, and more.

Many vendors of laboratory information management systems or electronic lab notebooks offer CRO-client portals; a dedicated portal makes it easy to share data, results, and samples with clients, customers, partners, and other external collaborators. Each client should have a separate dashboard that shows the results of each phase of their project. Both the FDA and the European Union have specific regulations affecting data sharing including the 21 CFR Part 11 (FDA)¹ and Annex 11 (EU),³ which require authenticated, authorized, and audit-trailed access to electronic records.

All this results in faster communication, fewer errors, and a smoother operational experience for both sides. If the client is using the same platform within its laboratory environment, the platforms can be connected, allowing access to the information critical to both parties.

Simultaneously, the aggregated dashboard infrastructure gives CRO management real-time insights into customer status, turnaround times, samples in progress, hours spent per client, instrument usage, and other activities that streamline corporate decision making. When the data are also available on a granular level, such as reagent usage, it streamlines resource allocation as well.

CRO success is not about replacing what already works; it’s driven by connectivity. A strong scientific foundation is a given. Success or failure depends on whether disconnected systems and manual handoffs can be replaced by a digitized lab. The key is incorporating lab automation, orchestration, data management, and AI technology together. When workflows, data, and client interactions are connected, visibility improves, delays disappear, and everything flows more smoothly. The more connectivity, the more scalable CRO operations become.

When a CRO has embraced efficiency and automation, strengthened data integrity and compliance, and driven the client experience toward excellence, they are on the path to long-term success. They’ll be delivering faster results, reliable data, and a professional experience that clients want to come back to—again and again.

References

1. 21 CFR PART 11, Electronic Records; Electronic Signatures. US Code of Federal Regulations. Accessed July 8, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11/subpart-B
2. Practical considerations for CROs to play FAIR. FAIR Cookbook. Accessed July 8, 2026. https://faircookbook.elixir-europe.org/content/recipes/introduction/fair-cro.html
3. EudraLex The Rules Governing Medicinal Products in the European Union, Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. European Commission. Accessed July 8, 2026 https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf

About the Author

Tim Stroud is an experienced life sciences professional with more than 20 years in the pharmaceutical drug discovery industry. Prior to joining Cenevo, he worked as a scientist and lab automation specialist in the pharmaceutical industry at Pfizer and AstraZeneca. He leads Cenevo's team of solutions consultants, who deliver expert support to the sales teams in providing laboratory automation and software solutions to our clients in the academic, biotech, pharma, hospital, and agriscience sectors. www.cenevo.com