July 7, 2026

Reducing Coordination Challenges When Working with Separate Clinical Operations and Biometrics CROs (1)

Outsourcing to Multiple CROs: Improving Coordination Between Separate Clinical and Biometrics Providers

Separating clinical operations and biometrics across two different CROs can give sponsors greater flexibility and deeper functional specialization. At the same time, outsourcing to multiple CROs requires ongoing vendor coordination to ensure clinical and biometrics teams are working together seamlessly.

JUMP TO:

Should you outsource to multiple CROs?
Operating as one team
Common pitfalls and mitigation strategies

In this article, PharPoint’s biometrics group shares some of the practical approaches we use to support coordination and collaboration when working alongside another clinical CRO group.

Should You Outsource to Multiple CROs?

A wide range of outsourcing models exist for biopharma companies. A model is typically selected based on variety of factors including company size, existing infrastructure, and overall company culture and working preferences.

While two of the most common outsourcing models are full-service and functional service provider (FSP) outsourcing, a myriad of blended options exists along the spectrum between these models.

One common outsourcing strategy that falls within this spectrum involves sponsors who choose to split their CRO services across two functional providers: one focused on clinical operations and one focused on biometrics.

Why do sponsors sometimes pursue this “multi-CRO” model?

Traditional embedded FSP arrangements often require significant sponsor-side infrastructure and oversight processes that may be unrealistic for smaller or emerging biotech companies to operationalize in a cost-effective manner. For sponsors outsourcing to two separate clinical and biometrics CROs, each provider is essentially functioning as a full-service CRO within its domain.

Sponsors may choose the multi-CRO path because the operational strengths that make a strong clinical CRO are not always the same strengths that make a strong biometrics CRO. Separating these functions allows sponsors to select each provider based on its specific area of expertise.

Sponsors often select clinical operations groups based on factors such as regional footprint, therapeutic expertise, and site relationships. Biometrics groups, on the other hand, may be selected for their proactive data management workflows, statistical expertise, or system capabilities.

For some, outsourcing to multiple CROs can also support additional efficiencies. Biometrics functions such as data management and biostatistics often provide sponsors with standardized processes and deliverables that provide consistency across an entire portfolio, even when clinical operations vendors must shift based on indication, phase, or global requirements.

What are the biggest concerns with using multiple CROs?

One common drawback to this model is the concern that involving multiple vendors will create additional operational burden on the sponsor. Delays, communication gaps, or unclear ownership between groups can negatively affect timelines, data quality, and overall study execution. This is especially of concern for leaner teams.

To avoid this, clinical and data teams must remain highly interconnected throughout the life of a study.

Operating as One Team Aligned Around a Shared Goal

PharPoint was founded as a data-focused CRO. Today, nearly two decades later, the organization has organically expanded to include clinical operations and full-service capabilities. However, we still have scenarios where our team works alongside other clinical CROs in a biometrics-focused capacity.

When contracted as part of a multiple-CRO outsourcing model, PharPoint’s biometrics group takes several steps to support a collaborative working relationship between our team and the clinical CRO. From our perspective, strong collaboration should begin as early as possible, allowing both teams to work as one unit well before the first data point arrives.

This collaboration includes:

Direct Visibility into Study Data

PharPoint’s biometrics team believes that effective collaboration requires direct visibility into study data rather than relying solely on status updates during meetings.

Timelines and Expectations Shared Upfront

We believe that both clinical and biometrics study teams should be fully aware of study timelines and expectations. From the biometrics point-of-view, this includes sharing details like delivery milestones, cleaning windows, and data readiness requirements upfront.

Shared Accountability

Metrics such as query trends, entry lag by site, and reconciliation gaps are shared operational responsibilities rather than isolated biometrics issues. These issues require joint resolution.

Common Pitfalls and Mitigation Strategies for Sponsors Outsourcing to Multiple CROs

Below are several challenges commonly encountered when working with separate clinical operations and biometrics CROs, along with practical approaches used to help mitigate their impact on study timelines and quality.

Pitfall	Strategy
Accountability gaps emerge between the clinical and biometrics CROs: Whenever multiple vendors work together, there is a potential for uncertainty around ownership for cross-functional activities.	Designate internal owners for cross-functional data touchpoints: PharPoint’s biometrics team typically addresses accountability gaps by designating internal owners for each cross-functional data touchpoint and ensuring proactive follow up between study counterparts rather than waiting for issues to escalate.
Data entry lags and unresolved queries build up: Delays in site data entry and unresolved queries can create downstream pressure on cleaning activities and database lock timelines.	Track aging queries and site-level entry trends: To help reduce this risk, biometrics groups should track aging queries and site-level entry trends in real time. This information should be shared regularly with the clinical group, with early warning signals raised before the database lock timelines are affected.
Teams fall into finger-pointing and blame culture: Operational challenges can become more difficult to resolve when teams prioritize assigning responsibility rather than resolving issues collaboratively.	Document decisions and follow-ups: To support clearer collaboration, study teams should clearly document decisions and follow-ups.
Sponsors must spend more time coordinating between vendors than expected: While sponsors must maintain oversight of their vendors, introducing function-specific CRO partners should not create substantial additional management burden for sponsor teams.	Clear and constant communication and coordination: Clinical and biometrics CRO groups should communicate directly with one another and maintain active operational coordination throughout the study. Sponsors should not routinely serve as the sole intermediary between vendors for day-to-day execution activities.

Pitfall

Strategy

Accountability gaps emerge between the clinical and biometrics CROs:

Whenever multiple vendors work together, there is a potential for uncertainty around ownership for cross-functional activities.

Designate internal owners for cross-functional data touchpoints:

PharPoint’s biometrics team typically addresses accountability gaps by designating internal owners for each cross-functional data touchpoint and ensuring proactive follow up between study counterparts rather than waiting for issues to escalate.

Data entry lags and unresolved queries build up:

Delays in site data entry and unresolved queries can create downstream pressure on cleaning activities and database lock timelines.

Track aging queries and site-level entry trends:

To help reduce this risk, biometrics groups should track aging queries and site-level entry trends in real time. This information should be shared regularly with the clinical group, with early warning signals raised before the database lock timelines are affected.

Teams fall into finger-pointing and blame culture:

Operational challenges can become more difficult to resolve when teams prioritize assigning responsibility rather than resolving issues collaboratively.

Document decisions and follow-ups:

To support clearer collaboration, study teams should clearly document decisions and follow-ups.

Sponsors must spend more time coordinating between vendors than expected:

While sponsors must maintain oversight of their vendors, introducing function-specific CRO partners should not create substantial additional management burden for sponsor teams.

Clear and constant communication and coordination:

Clinical and biometrics CRO groups should communicate directly with one another and maintain active operational coordination throughout the study. Sponsors should not routinely serve as the sole intermediary between vendors for day-to-day execution activities.

Conclusion

When managed effectively, separating clinical operations and biometric services across multiple CROs can provide sponsors with specialized expertise and long-term operational consistency as your organization grows and evolves. However, success within this model depends heavily on how well these groups coordinate throughout the life of a trial.

For sponsors interested in discussing flexible approaches to outsourcing or to learn more about how PharPoint can seamlessly work with other CRO partners, reach out to our team.

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