Beyond the Tracker: Gaining Oversight and Improving Quality in Outsourced Trials

Feb 26, 2026 | Frank Lin

Outsourcing clinical trial operations continues to be a common operating model for small and scaling biopharmas, but it introduces a problem: maintaining proper oversight and being able to react quickly. Without a clear view into trial execution, sponsors risk data quality problems and can struggle to course-correct when things go wrong. Success hinges on balancing delegation with strong CRO partnership, clear communication, and a technology foundation that supports standardized metrics and data.

I recently spoke with Aileen Ilaria, vice president of clinical operations at New York-based biotech Immunovant, and Sarah Dean, executive director of clinical systems at global CRO Precision for Medicine, to discuss their journeys to improving oversight in outsourced clinical trials. Here are the key takeaways for clinical operations leaders:

Gain oversight by replacing fragmented clinical trial systems

Immunovant invested in an in-house clinical trial management system (CTMS) to address fragmented processes and trial delays due to lack of oversight. For sponsors considering the switch, Ilaria suggests the “tipping point” is when trackers become unmanageable. For her team, this was around five or six trials going simultaneously, particularly Phase II and III studies. “We were looking forward to exponential portfolio growth while hitting the breaking point of what we could continue to do through trackers,” she explains. “We couldn’t make decisions quickly enough or properly allocate resources because we were working with week-old data.”

Similar needs led Precision for Medicine to make the switch. “When you have a CTMS from one vendor and an eTMF from another, you’re capturing data and exporting it from multiple, disconnected systems,” says Dean. “We didn’t have oversight over our projects, and in turn, we couldn’t give our sponsors oversight.”

Ultimately, both Ilaria and Dean decided to invest in their own management systems to achieve their long-term goals. “Now that we’ve standardized on Veeva, we have one unified platform. We can work on our documents in our Veeva CTMS, and easily exchange them with sponsors using CTMS Transfer,” Dean notes.

Setting system expectations during RFP and bid defense

Both Immunovant and Precision for Medicine agree that aligning on system capabilities early during the RFP and bid defense process is key. In bid defense meetings, Dean tries to get a sense of what the sponsor’s system capabilities are and how her team will gain access. Ilaria added that ensuring SOWs have specific language around data exchange, timeliness, and error resolution is crucial. “We like to have both business and IT folks at the table to make sure operational definitions match,” she mentions. “A CRO may have one name for a field and we might have another, which can cause data issues down the road.”

Functional service provider, full service outsourcing, or hybrid: choosing an operating model

When choosing an operating model – functional service provider (FSP), full service outsourcing (FSO), or hybrid – the decision depends on “what we need for a particular study,” says Ilaria. Right now, her team is in the early stages of considering a switch to FSP, but still uses the full-service model for all studies.

Dean primarily deals with FSO projects, where her team uses their in-house Veeva CTMS for tracking and oversight. However, Dean’s team is committed to flexibility to meet each individual sponsor’s needs. “Regardless of the operating model, we always use Veeva CTMS and Study Startup on our end to track our studies and have oversight of milestones,” Dean explains. “Veeva allows us to do everything all in one place.”

Ultimately, both agree that success hinges on open conversations and collaborative partnership throughout the study lifecycle.

Improve data quality by setting standards

For Ilaria, a primary lesson from Immunovant’s Veeva CTMS implementation was the critical need to establish data standards early when engaging with new CROs. Each CRO has its own way of ingesting data and assigning operational definitions, which can cause problems.

For instance, a sponsor may discover that even if a partner uses a CTMS, essential metrics like site activation data may still be tracked in spreadsheets. To resolve this, Ilaria brings together a group of business and IT personnel to walk through these discrepancies before starting a trial. “For successful data harmonization, you have to be able to literally walk through it field by field,” she explains.

CTMS adoption: key lessons and next steps

From the CRO perspective, Dean identified deep collaboration as the central lesson, stressing the need for transparent conversation to align different operational perspectives. She explained that CROs must conduct their own oversight to ensure quality before delivery, while sponsors simultaneously need accurate data “at your fingertips as close as possible to when it’s been done.”

With an in-house CTMS, Ilaria’s team has more real-time data to guide their decision-making than they did before. This includes granular metrics like regional enrollment analysis. “As a lean team, having a portfolio of six trials going on simultaneously stretches your organization thin,” Ilaria notes, “Knowing where you need to put resources is key.”

After setting up CTMS Transfer, which Ilaria called “the easiest of all of our integrations,” she is focusing on expansion. Immunovant aims to integrate screening and enrollment data by the end of year, with plans for Veeva EDC integration and flowing protocol deviations by next year.

See how to gain visibility, increase efficiency, and standardize reporting processes for outsourced studies.