In the highly regulated and competitive pharmaceutical industry, maintaining the quality and efficacy of products is critical. One effective strategy many companies use is entering into Full-Time Equivalent (FTE) agreements with Contract Research Organizations (CROs). This model is especially advantageous for analytical research & development and quality control (QC) testing services.

FTE contracts have evolved into a widely accepted and advanced form of collaboration between pharmaceutical companies and CROs. Since their early adoption in the mid-2000s, FTE agreements have become one of the most effective ways to accelerate drug development.

This white paper outlines the essential principles, practical applications, and key benefits of FTE agreements with CROs—particularly in the context of analytical method development and quality control.

 

What is an FTE Contract?

An FTE contract provides a dedicated team of CRO scientists and resources who work exclusively on the client’s project. These professionals operate as an extension of the company’s internal team, offering specialized expertise that may not be available in-house.

In many cases, in-house scientists are needed on core development programs, and outsourcing secondary, but still critical projects under an FTE model ensures progress without sacrificing internal focus. At Conscio Group, we have offered this model, primarily for analytical method development and QC testing, for over five years. Here’s why pharmaceutical companies value this approach.

 

Flexibility and Scalability

One of the greatest advantages of FTE contracts is their scalability. Pharmaceutical companies can adjust the level of support based on project demands. This flexibility is particularly valuable during different stages of drug development, when the need for analytical or QC support can fluctuate. With a well-structured FTE agreement, R&D and GMP resources can be combined effectively, allowing for smoother transitions and faster result generation.

 

Enhanced Collaboration and Communication

A dedicated team working under an FTE contract engages in continuous communication with the client’s internal teams. This alignment leads to faster decision-making, stronger collaboration, and quick adaptation to changing requirements. Typically, both parties review resource needs monthly, enabling proper capacity planning. While the total number of FTEs may vary month to month, minimum and maximum thresholds are predefined at the beginning of the collaboration.

 

Cost Efficiency

Compared to traditional project-based contracts, FTE agreements can be more cost-effective. Instead of paying per test or sample, clients pay a fixed rate for dedicated personnel, leading to better budget predictability. Additionally, it eliminates the need for frequent renegotiations and change orders, reducing administrative overhead.

In certain cases, our clients have reported cost reductions of up to several tens of percent compared to traditional project-based contracts. FTE contracts are particularly suited for long-term projects, where ongoing collaboration justifies the allocation of CRO resources. Short-term engagements are less feasible, as they make it difficult for CROs to commit the necessary staff.

 

Consistency and Quality

At Conscio Group, FTE teams working on analytical method development and QC testing gain deep knowledge of a client’s processes, resulting in consistent and reliable outcomes. This consistency is crucial for maintaining compliance with regulatory standards and ensuring the safety and efficacy of pharmaceutical products.

Moreover, stable “FTE team” means also stability for the pharma companies as they thus know who is working for them on their projects. They understand what to expect and how to communicate their needs to the team they already know.

 

Access to Advanced Technologies

CROs typically maintain access to state-of-the-art analytical technologies. By entering an FTE contract, clients gain access to these advanced tools without needing to invest in new equipment themselves. This is especially important during method development, where it’s often unclear which analytical techniques will be most effective. Having a well-resourced CRO partner means equipment and expertise are readily available, minimizing downtime and enabling adaptive development.

 

Focus on Core Competencies

By outsourcing analytical development and QC testing under an FTE model, pharmaceutical companies can concentrate on their core strengths, such as drug discovery, regulatory strategy, and clinical planning without overburdening their internal teams.

 

Case Study: Supporting a Biotech Pipeline

A European biotech company developing two novel New Chemical Entities (NCEs) needed to rapidly transition from pre-clinical to clinical phases while analytical methods were not properly set yet. To meet this challenge, they partnered with Conscio Group under a FTE contract focused on both analytical method development and GMP-compliant quality control (QC) testing.

The initial agreement was concluded for a period of one year, allowing for long-term planning while maintaining flexibility. The contract outlined fixed rates for each service category and clearly defined the resource allocation: up to three R&D scientists and two QC analysts during the validation phase. Any items outside the fixed FTE pricing, such as ion-exchange chromatography columns or custom synthesis of reference standards were transparently listed and approved in advance.

Project coordination were based on a dual reporting model:

• At the end of each month, both teams participated in structured online meetings to assess ongoing development needs, discuss potential changes in strategy, evaluate new analytical approaches, and agree on the number of FTEs required for the following month.
• Weekly reports summarizing progress, open issues, and the next steps were delivered every Friday, providing the client with a clear and up-to-date view of project status. These summaries often served as a trigger for rapid tactical decisions or process modifications.

This structured yet flexible communication setup ensured efficient resource planning and adaptive project execution.

As the project advanced into the GMP phase, the original R&D team continued to support the validation team, facilitating a seamless transition between development and regulated testing. The communication frequency and reporting structure remained unchanged, now with the active involvement of both R&D and QC teams.

Thanks to this integrated collaboration model, the project was successfully completed within four months of GMP initiation, without any deviations, delays, or unexpected complications.

The biggest advantage of such cooperation lies in the proximity of both teams (R&D and GMP) and their knowledge of such collaboration with their peers. Having both teams literally under one roof is undoubtedly the advantage which speeds up the work and client benefits out of it.

 

Conclusion

FTE contracts offer a smart, scalable, and collaborative way to outsource analytical services in pharmaceutical development. With advantages such as cost efficiency, team continuity, access to cutting-edge technology, and improved communication, this model allows companies to optimize their operations and remain focused on their strategic goals.

 

Is an FTE Contract Right for You?

Consider this model if:

You are managing long-term or multi-phase analytical and QC projects

You need predictable monthly budgeting without renegotiation

You require deep integration between internal and external teams

You are looking to reduce delays due to onboarding, procurement, or repeated coordination

 

What are the benefits of partnering with Conscio Group?

Conscio Group possesses a mixture of the essential services needed for successful drug development. With over 300 pharmaceutical professionals across our strategically located laboratories in Czechia, Slovakia, Germany and Austria. With over 20 years of continuous operation under EU and US-FDA regulatory oversight, we have the infrastructure and expertise to handle a wide variety of dosage forms, manufacturing scenarios, and regulatory challenges.

Our integrated services include below activities for both small molecules and biologics:

• Formulation development
• IMP manufacturing under the GMP
• Analytical method development and optimization
• Analytical method validation, verifications, transfers
• QC testing of clinical and commercial medicinal products
• 250 m³ of stability chambers for both ICH and atypical storage conditions
• PK studies on healthy volunteers
• Bioanalytical testing

In addition, our services cover analysis of a wide portfolio of dosage forms: solids, semi-solids, liquids, injectables, ODFs, patches, and more

 

Sources

[1] Full-Time Equivalent Agreements | Contract Pharma

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