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Jan 07, 2026 | Sid Mohamoodally

If given the choice, most sponsors would opt for more control and visibility over their data. But when sponsors outsource clinical data management, the technology decisions that govern these factors are often left to the contract research organization (CRO). When the CRO chooses the technology, sponsors may not have insights into data collection, management, and analysis. This creates a ‘black box’ scenario where the sponsor has to trust the CRO’s processes without full transparency.

Sponsors should feel empowered to request the technology that’s best for their study, particularly in light of recently released ICH E6(R3) guidelines that emphasize the sponsor’s responsibility for how data is collected. Without direct access to all patient data, it’s harder for sponsors to effectively oversee data quality, identify potential issues in a timely manner, or ensure compliance.

Here are three reasons why sponsors should decide which clinical data technology their CRO will use:

1. Sponsor oversight and ICH E6(R3) compliance

Transparency and real-time access to study data enable oversight and compliance with ICH E6(R3). The new guideline brings focus to clinical processes and data lineage: in addition to end-of-study documentation, sponsors need to show they ensure patient safety and data integrity, traceability, and security by making the right decisions at the right time.

Two critical principles governing this are direct ownership and proportionality. Direct ownership mandates that data managers need direct access to data on demand without navigating through multiple groups, eliminating the game of telephone. Proportionality requires a risk-based approach, meaning the rigor of quality management, monitoring, documentation, and data oversight should be directly proportional to the risk and importance of the data (Critical-to-Quality or CtQ), eliminating unnecessary work and focusing controls where they are most impactful.

Timely and accurate reporting from CRO partners is essential for effective sponsor oversight. Delays or inaccuracies in reporting can hide critical issues, such as protocol deviations or safety concerns, jeopardizing the trial’s validity and exposing the sponsor to significant regulatory risk.

2. Value from modern clinical systems

Connecting the data flow between sites, sponsors, and CROs enables biotechs and their partners to:

Increase efficiency: Automation streamlines data ingestion from multiple external and internal sources, allowing sponsors to make fast, data-driven decisions that improve overall data quality.

Speed up timelines: Connected clinical applications help accelerate timelines and minimize risk of delays. When CROs use a patchwork of legacy technologies, the drivers behind high costs and lengthy timelines are hidden from the sponsor. Outdated technology is a primary contributor to high EDC setup costs due to the heavy dependence on custom programming in older EDCs.

Improve the site experience: A survey of 10,000 site professionals found that the top challenge they faced in 2025 was managing logins and passwords (72%), closely followed by the growing number of sponsor-selected vendors (71%). There is a risk that sites will turn down studies that require them to use multiple systems, as a lack of consistency could compromise their ability to serve patients. Sponsors that provide a simplified and standardized tech experience for sites will position themselves as sponsors of choice in a competitive market.

Sponsors gain value when their CRO uses connected clinical data applications including CTMS, EDC, and a clinical data workbench to aggregate data from multiple data sources and automate data cleaning. Modern EDC and CTMS capabilities offer comprehensive dashboards and reports and give sponsors direct access to trial data as it’s being collected.

A principal clinical data scientist at a global CRO explains the importance of frequent reporting: “Sponsors have overall oversight of the entire study, so it’s clearer and easier for us to communicate what the metrics look like, especially when you have studies with a high volume of data and very fast timelines. The EDC integrates subject status directly into form progress reports. This eliminates the frustrating step of cross-referencing multiple reports, and makes it easier for clinical teams to monitor data and perform SDV.”

By using the same clinical platform, sponsors and CROs can collaborate more effectively and foster trust by knowing they’re looking at the same data simultaneously. Staci McDonald, vice president of global clinical operations at Celerion, explains the benefits of a connected platform for her team’s relationship with sponsors: “It has given transparency and a higher level of trust because they see exactly what’s going on at the site. It has made our weekly meetings more effective because we don’t only talk about the classic updates, but also where there’s risk.”

3. Vendor partnership and cost predictability

Whether a sponsor licenses technology through a third party or in-house, Veeva’s license costs include the base fee and patient fee, meaning sponsors can calculate the cost over time and account for factors like growth or delays in patient recruitment.

“The pricing is the same regardless of whether it’s the CRO or sponsor Vault. That makes Veeva an easy decision,” explains the associate director of clinical data management at a specialty biopharma company. They comment on their team’s experience bringing Veeva EDC in-house, while outsourcing data management: “Veeva’s managed services representative works very closely with us and our analytics partners. We were able to get immediate answers to questions, or any site or build challenges that we were having when we were licensing through a third party.”

How to ask your CRO for Veeva

steps to consider when preparing to request technology from a CRO chart

Sponsor example: Replimune

As a biotech company with a hybrid outsourcing model, Replimune retains ownership of the technology and outsources data management services to CROs. The team specified using Veeva technology in the request for information and proposals for trial start-ups. For its larger and longer-running Phase III studies, Replimune implements full-service outsourcing with both clinical operations and data management services together.

“CROs are mostly tech agnostic. They can generally do their work in any system. For those that have built their services around their core technologies, as a first step we carry out an assessment to identify necessary procedure adjustments or updates to align with the adoption of Veeva technology,” – Regina Norelli, Executive Director, Clinical Data and Sample Management at Replimune

A strong partnership between sponsor and CRO data management teams is crucial, to navigate SOPs, work instructions, and templates that are outsourced to the CRO well in advance of trial startup. “My recommendation is to bring Veeva to the table for that exercise,” comments Norelli.

“When sponsor and CRO partnerships are developed with clear processes, expectations, and proactive training, we can design execution and oversight for quality and efficiency.”

Sponsor example: TG Therapeutics

TG Therapeutics’ approach is to have a preferred vendor for every study, to keep data consistent. The biotech was using three or four different EDCs for a Phase I study, evaluating which was the best fit. Their CRO partner proposed using Veeva EDC, having recently become a partner using the Veeva Clinical Platform.

“We had a lot of positive feedback from the internal team and the sites using [Veeva EDC], which was the impetus to further explore the CRO partnership.” – Daniel Gay-Betton, Associate Director Clinical Vendor and Program Management, TG Therapeutics

The sponsor’s approach is to ask CROs at the bid stage what their preferred vendor is. At re-bidding, TG Therapeutics specify which technology will be used and ask the CRO to get quotes for a specific EDC or lab. “It’s our obligation to know what’s best and go for that.”

TG also wanted to explore potential efficiency gains through bringing Veeva EDC in-house. “With that decision, we would then have to inform our other CRO partners that we wanted to use this technology,” explains Gay-Betton. “We have the power and the obligation to manage the data correctly, so we can tell the CRO that we want to use an industry standard like Veeva EDC. I’ve never had a CRO push back heavily.”

The driver behind greater control and oversight over clinical data at TG is a top-down initiative for inspection readiness. “It’s your data you’re getting out of it. Not only from a regulatory stance but from a business perspective, you want to have the best data quality.”

CRO example: Indero

Most CROs work with a roster of pre-validated technology vendors and will recommend solutions to sponsors based on the CRO’s experience, the specifics of the protocol and study, and available budget. Éric Hardy, senior director biometrics at Indero, explains his team’s collaborative approach to technology selection: “We always take the sponsor’s requirements into account and our business development team works closely with them to understand their preferences of the proposed technology. Sometimes, sponsors already have a preferred vendor in mind. We’re flexible and are capable of working on various systems but ultimately, the choice lies with the sponsor.”

When sponsors choose to manage their own vendors, Hardy’s team provides a thorough risk assessment and discusses the findings directly. He adds: “Integration between systems is a critical consideration for us. We often highlight potential integration challenges as part of our risk evaluation. Drawing on our experience with Veeva, we’re able to help sponsors make informed decisions about vendor selection.”

Find your next CRO partner

By actively engaging in technology discussions, biotech sponsors can move beyond a ‘black box’ approach, ensuring direct access, control, and ownership of their invaluable clinical trial data. Don’t let technology be an afterthought. Making informed choices about the underlying clinical trial technology is a strategic decision that can accelerate your clinical trials and enhance compliance.

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