Key Takeaways:

Onshore resourcing supports higher quality outcomes, stronger communication, and dependable timeline alignment, especially in clinical and biometrics functions.
Offshore resourcing is cost-effective and scalable but requires additional oversight, compliance considerations, and coordination across time zones.
U.S. reshoring trends in technology and pharmaceuticals mirror what Redbock is observing among life science clients.
Choosing onshore vs. offshore depends on regulatory risk, complexity, quality expectations, responsiveness, and how much control the sponsor needs.
For roles tied directly to study timelines, data integrity, or regulatory submissions, onshore resourcing provides measurable advantages.

Over the years, there has been a significant shift toward offshore resourcing, as it has become an attractive and common strategy for companies seeking ways to manage budgets while accessing a wide global candidate pool. Recently, however, many U.S. companies have begun reassessing how much work should be retained overseas, particularly in functions where regulatory expectations, operational reliability, and immediate communication are central. Several external factors have contributed to this reassessment, including geopolitical uncertainty, higher operational risk outside of the U.S., and the growing need for greater control in regulated industries.

IndustryNet reports that 35% of organizations are planning or evaluating “reshoring”, a substantial increase from the long-standing average of 1-2%. This activity is most visible in technology and pharmaceuticals, both of which share characteristics with the life science sector, such as complex compliance requirements and high sensitivity to operational disruption.

PwC also notes that many U.S. organizations are moving toward more regionalized operating models to strengthen control over production, reduce exposure to international variability, and support ESG targets. While these findings focus on manufacturing and supply chain functions, the same motivations are influencing workforce decisions. Redbock sees similar patterns among sponsors that require greater proximity and accountability in areas such as clinical and biometric operations.

For life science companies reviewing onshore and offshore resourcing models, these broader market dynamics raise important questions about where work is performed more effectively, how teams should be structured, and which approach best supports compliance and study timelines.

What Do “Onshore” and “Offshore” Actually Mean?

Onshore Resourcing

Onshore resourcing refers to hiring or contracting professionals within the same country where the organization operates. For U.S. sponsors, this means professionals based within the United States, working under the same legal framework, regulatory expectations, and business hours, either hired independently or employed through a consulting firm. Although cost is higher for this model, alignment and oversight are considerably smoother due to everything being locally based.

Onshore teams typically bring:

Familiarity with U.S. regulatory standards
Cultural and linguistic consistency
Simplified compliance and IP protections
Direct experience with FDA expectations and submission conventions
Real-time access for site-related issues, escalations, and cross-functional discussions

Onshore hiring is most used in:

Clinical Operations
Data Management
Biostatistics and Statistical Programming
Regulatory Affairs
Quality Assurance

Offshore Resourcing

Offshore resourcing involves hiring teams from countries outside a company’s home borders. Organizations often pursue this strategy to take advantage of lower labor costs or access to a skilled workforce. Common offshore locations include India, various regions in Eastern Europe, Southeast Asia, and parts of Latin America.

Offshore teams often support:

IT development
Standardized or large-volume programming tasks
Global support functions that benefit from 24/7 coverage
Structured processes with predictable workflows

The core appeal of offshore hiring is its cost efficiency and scalability, although companies must also account for factors such as communication delays, increased compliance complexity, and additional oversight.

Pros and Cons of Onshore Resourcing

Advantages

1. Direct Communication and Faster Decision-Making

Effective communication and quicker decision-making are crucial in complex studies. When teams share the same time zone, it becomes much easier to address data issues, questions about protocols, and safety events promptly. This enables smoother discussions and more efficient problem-solving, ultimately reducing delays and obstacles in the process

2. Higher Seniority and Functional Maturity

Many U.S.-based contractors working in clinical and biometrics roles have extensive industry experience, often spanning decades. Their backgrounds frequently include repeated involvement with key regulatory milestones such as INDs, NDAs, BLAs, and advisory committee preparation. This depth of experience reduces the need for rework and increases reliability in high-pressure phases.

3. Regulatory Coordination

Onshore professionals operate inside the same legal and compliance environment as the sponsor. This reduces ambiguity around functions such as:

FDA meeting preparation
Inspection readiness
21 CFR Part 11 expectations
Data privacy standards
Documentation conventions

4. Stronger Fit for High-Complexity Tasks

Adaptive trial designs, decentralized trial components, real-time biomarker decisions, and increasingly sophisticated statistical methodologies benefit from personnel who have worked in similar regulatory contexts for years.

Limitations

1. Higher Cost

Labor, taxes, and operational overhead in the U.S. result in higher contractor and consultancy rates. For example, U.S.-based statistical programmers earn on average $131,243/year (~$63/hour), with senior professionals reaching $162,757/year (~$78/hour) (SalaryExpert). Biostatisticians show similar trends, with median pay around $108,907/year (~$52/hour). In contrast, equivalently skilled offshore programmers in India or Eastern Europe are commonly billed at $25–50/hour. This differential explains why offshore talent remains attractive for budget-sensitive work.

**Salary figures are approximate and may vary depending on source and role specifics.

2. Limited Availability of Niche Specialists

In certain specialized therapeutic fields and with the rise of new data technologies, we often see a shortage of skilled professionals available locally. This issue becomes even more apparent during peak hiring periods when the demand for qualified candidates significantly increases.

Pros and Cons of Offshore Resourcing

Advantages

1. Cost Efficiency

Offshore resourcing can lead to impressive cost savings, often cutting labor expenses by half or even more, depending on the specific region and type of work. Countries like India, the Philippines, and various Eastern European nations provide access to talented professionals at a fraction of the costs typically seen in the U.S. This makes offshore teams an attractive option for projects that need to stay within strict budget limits. Although the exact amount of savings can differ, the potential for significant reductions in both labor and overhead costs is a major factor driving companies to consider offshore solutions.

2. Access to Broad Global Labor Pools

Specific technical disciplines, such as full-stack software development, automated testing, and high-volume programming, benefit from the size of the global labor market.

3. Scalability

Offshore teams have the advantage of quickly scaling when projects demand high output or require continuous operation. This ability to adjust swiftly to team size enables companies to effectively handle fluctuations in workload, ensuring they can meet tight deadlines while maintaining steady productivity levels.

Limitations

1. Oversight Requirements

Managing offshore teams requires additional structure. Examples include:

Detailed documentation
Standardized workflows
Increased QC and validation
More frequent governance meetings

Projects without strong management often see inconsistencies or delays.

2. Time-Zone Lag

Despite the availability of global teams offering extended working hours, a significant challenge remains in aligning with U.S. business hours. This misalignment can lead to substantial delays in resolving critical issues, particularly in areas such as clinical operations and biometric data management.

3. Compliance Complexity

Clinical data handling across borders introduces:

Multi-jurisdictional privacy concerns
Additional vendor oversight obligations
Tighter scrutiny during audits

These requirements increase administrative load.

Which Model Is Right for Your Business?

Where Onshore Works Best

Clinical Operations

Study timelines move quickly, and escalation needs immediate attention. Onshore clinical contractors consistently deliver faster resolution and extensive site familiarity.

Biometrics (Biostatistics, SAS Programming, Data Management)

Submission-critical work benefits senior hands who understand regulatory expectations intuitively.

Regulatory, QA, and Inspections

Interpretation of evolving U.S. regulatory requirements is more streamlined when teams are trained in the U.S. environment.

Where Offshore Works Best

Technical Development and High-Volume Programming

When the work is well-defined and can be executed according to clear specifications, offshore teams provide strong efficiency.

24/7 Support and Monitoring

Offshore locations can extend operational coverage without the need to build large onshore teams.

Summary: What Are the Main Differences Between Onshore and Offshore Resources?

Factor	Onshore	Offshore
Cost	Higher labor & overhead costs	Lower labor costs; scalable
Expertise Level	Strong seniority; vast regulatory experience	Highly variable; strong for technical execution
Communication	Real-time, same-day collaboration	Time-zone delays; structured communication needed
Regulatory Alignment	High – same jurisdiction as sponsor	Requires additional compliance supervision
Best For	Clinical Ops, Biometrics, Regulatory	IT, standardized programming, support functions
Scalability	Moderate; limited by the domestic market	High; large global networks
Risk Profile	Lower operational and compliance risk	Higher oversight requirements

Partner with Redbock

Redbock, a trusted life science consulting and resourcing partner, helps companies navigate the choice between onshore and offshore resourcing with confidence. Whether you require the proximity and regulatory familiarity of U.S.-based experts or the cost advantages and scalability of offshore teams, Redbock ensures you have access to the right professionals at the right time.

Contact us today to learn more about our resourcing solutions

FAQs

What is the difference between onshore and offshore resources?

Onshore resources are professionals based in the same country as the sponsor, working under the same regulatory framework, business hours, and legal environment. Offshore resources are based in other countries and are typically used to reduce costs or scale delivery for well-defined work.

When does offshore resourcing make sense for life science companies?

Offshore resourcing is generally a good fit when the work is clearly defined and follows established processes. Tasks like high-volume programming, technical builds, or ongoing support are often well-suited to offshore teams, especially when timelines are predictable.

Why do sponsors often choose onshore teams for clinical and biometrics roles?

Clinical operations and biometrics are closely tied to decision-making, regulatory expectations and study timelines. Sponsors often lean toward onshore teams here because issues can be addressed quickly and discussions happen in real time. When timelines are tight, that immediacy can make a measurable difference.

Is offshore resourcing riskier from a compliance perspective?

Offshore resourcing isn't inherently non-compliant, but it does add complexity. Cross-border data handling and vendor oversight typically require more structure and documentation. Sponsors who succeed with offshore models usually plan for that extra layer of governance from the outset.

Should companies choose onshore or offshore resourcing to control costs?

Lower hourly rates don't always translate to lower overall costs. Offshore teams can reduce spend on well-scoped work, but onshore resources often help avoid delays, rework, or escalation during high-risk phases. Sometimes the most effective approach is a hybrid one, using offshore teams where efficiency matters most and onshore expertise where quality and control are critical.

Expertise

Program & Project Management

Clinical & Biometrics

Regulatory & Compliance

Quality

Engineering

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