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EXPERTISE

Functional Service Provision

Supporting your pipeline needs with a cost-effective and high-quality solution.

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Accelerate success with flexible expert solutions

As a Functional Service Provider, Quanticate can offer support in specific functions from small scale support through to large programs. 

Our customers range from small biotechnology companies through to Top 5 global pharmaceutical companies. A Functional Service Provision (FSP) approach could be the answer that you are looking for because dedicated functional teams supporting your clinical trial can help solve your challenges.

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Tailored & Efficient Solutions for Your Pipeline Needs

At Quanticate, our Functional Service Provision (FSP) models deliver specialised services tailored to ensure trial integrity, regulatory compliance, and reliable outcomes.

Statistical Programming

Statistical Programming

Our team are experts in managing complex datasets, generating custom reports, and preparing submission-ready data packages. We understand how critical accuracy and consistency are for regulatory submissions, and we ensure every detail meets the highest standards.

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Biostatistics Services

Biostatistics

Our biostatisticians can provide specialist support across all key activities such as trial design, sample size calculations, and thorough statistical analysis. By partnering with us, you can tap into this expertise without the need for a full in-house team, ensuring your trials are designed and analysed with precision.

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Clinical Data Management Services

Clinical Data Management

We offer advanced data management services, including handling complex databases, implementing rigorous data quality controls, and managing electronic data capture (EDC) systems. With our support, you can maintain strong data integrity and compliance while reducing the demands on your internal resources.

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Biostatistics Consultancy Services

Additional Core Services

As part of our core functions, we can also provide support in medical writing, pharmacovigilance, monitoring, and project management, using advanced tools and methodologies to enhance efficiency and accelerate therapy development.

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Experience Seamless Clinical Trial Support

Discover how our tailored solutions streamline processes, ensure compliance, and drive success. Contact us today to discuss your needs!

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Our Functional Service Provision Models

We offer different solutions, so you can choose the model that fits your operational needs, trial complexity, and resource requirements. Each FSP model provides specific benefits. You select based on the level of control, flexibility, and specialisation you require. These models have various pricing structures, including time and materials, fixed price, full-time equivalent (FTE), unit-based, and output-based arrangements. By selecting the appropriate model, you can customise your outsourcing strategy to meet your clinical trials needs.

Full-Service FSP Model

We will take complete responsibility for specific functions, such as data management or biostatistics, from planning to execution. As the sponsor, you delegate all aspects of the outsourced function, allowing a hands-off approach while benefiting from our specialised expertise.

Ideal For: Sponsors wanting to outsource specific functions entirely without daily management involvement.

Hybrid FSP Model

This model combines FSP with Full-Service Outsourcing (FSO). You retain direct control over certain important functions while outsourcing others. For example, you may use FSO for overall trial management and employ FSP for specialised tasks like statistical programming.

Ideal For: Sponsors seeking a mix of control and outsourcing, keeping core functions in-house while using Functional Service Providers for others.

Dedicated FSP Model

We will deploy a team of our specialists to work exclusively on your projects, providing consistent support and ensuring team continuity. The dedicated team will operate within your systems and processes.

 

Ideal For: Sponsors needing long-term support across multiple projects or requiring deep integration with CRO personnel.

Staff Augmentation FSP Model

We provide additional personnel to supplement your existing team. This model allows you to fill resource gaps temporarily without long-term staffing commitments, ideal for periods of high demand.

Ideal For: Sponsors needing temporary workforce increases or specific expertise for short-term projects.

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Niche Providers: The Genuine FSP CRO

For over three decades, we've provided top-tier biometrics services to the industry using our Functional Service Provision (FSP) models.

As a specialist CRO, we focus exclusively on biostatistics, statistical programming, clinical data management, medical writing, and pharmacovigilance. By concentrating on these critical areas, we deliver high-quality and efficiency in managing clinical trial data. 

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Focus on Data Expertise

As a company founded by Statisticians, data is at our core. By focusing solely on data-related services, we've develop deep expertise. Our dedication to biometrics enables us to refine processes, meet regulatory standards, and use advanced technologies tailored to data analysis and management. 

Our specialised teams ensure data accuracy and consistency, leading to reliable trial results. In addition, our well established and optimised workflows, together with our automated processes, minimise errors and accelerate timelines from data collection to analysis. 

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Integrated Biometrics Services

Combining data services under one provider offers significant advantages. As a niche biometrics CRO, we integrate biostatistics, statistical programming, data management, pharmacovigilance, and medical writing, providing a cohesive approach to data handling.

  • Streamlined Communication: Managing all data services with us simplifies communication and ensures aligned objectives. 
  • Consistent Data Handling: Our integrated services enhance data integrity and facilitate accurate analysis and reporting.
  • Cost and Time Savings: Consolidating with us reduces your administrative overhead and optimises internal processes for faster project completion.
  • Customised Solutions: We tailor our services to your clinical trial needs, offering flexibility in statistical plans and data strategies. 
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The Advantages of a Specialised Biometrics CRO

Consider a large sponsor conducting a multi-phase clinical trial requiring extensive data analysis and reporting. By partnering with a niche biometrics CRO:

  • The biostatistics team play a pivotal role in clinical study design and create a statistical analysis plan incorporating robust statistical methodologies that ensure the validity of trial results.
  • Statistical programmers efficiently transform complex data into meaningful outputs that are peer reviewed by the biostatistics team, facilitating clearer insights and supporting decision-making processes.
  • The data management team ensures high-quality data collection and cleaning, reducing the incidence of queries and data discrepancies.
  • Medical writers proficient in data interpretation craft precise and compliant clinical study reports and regulatory submissions. Additionally, biostatisticians can assist with any difficult interpretations of the results if needed.
  • Pharmacovigilance experts monitor and analyse safety data in real-time, ensuring participant safety and regulatory compliance.
    This integrated approach not only improves the quality and reliability of the trial outcomes but also accelerates the overall timeline, enabling the sponsor to bring new therapies to market more swiftly.
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Centralising Data Services

Clinical trials generate extensive data, and ensuring its validity and correct interpretation is crucial. Once a study ends, only the data remains, highlighting the importance of utilising a specialised biometrics CRO such as Quanticate to handle all data-related aspects. We embody the Functional Service Provision model by providing specialised, high-quality data services vital for clinical trial success.

Our focused expertise enhances quality, boosts efficiency, and streamlines processes. By centralising data services with us as your dedicated provider, you'll gain efficiencies, reduce complexities, and speed up therapy development. Partnering with us allows you to confidently manage your clinical trial data. 

FSP Expertise

Empower Your Team with FSP Expertise and Scalability

By forming an FSP relationship you will receive:

  • Access to the expertise you need
  • Flexibility to use this expertise for the amount of time it is needed
  • A trusted partnership which will be seen as an extension of your own in-house team
  • Efficiencies that improve both quality and timeliness of deliverables
  • Freedom to focus on your core activities and use experts that are accountable for their deliverables
  • A scalable workforce giving you the ability to monitor resource demands on a continual real-time basis
  • Multi-region support
  • On-site and off-site solutions that enable the FSP team to become “embedded” in your company structure and culture
  • Reduced need to hire permanent resources or rely on individual contractors

Scale Smarter, Deliver Faster with Flexible FSP Solutions

Ready to transform your clinical trial processes with a trusted FSP partner? Contact us today to discuss how our tailored solutions can empower your team and deliver exceptional results.

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Embracing FSP Models

Rising Adoption and Strategic Implications for Biopharma

Industry trends show a growing preference for FSP models. Historically, larger sponsors split their outsourcing between FSP and full-service models at 48% and 52%, respectively. Smaller sponsors used FSP for 36% of their outsourcing and full service for 64%. In 2018, providers reported that 57% of their revenue came from FSP arrangements, compared to 43% from full-service contracts.

Between 2018 and 2023, the adoption of FSP increased from 28% to an estimated 45–50% among biopharma companies. This growth is expected to continue at an annual rate above 8.5%. The rise is driven by sponsors' need for scalable solutions, specialised expertise, and better technological integration, especially as trial complexity increases worldwide. Understanding these shifts helps sponsors consider their outsourcing strategies effectively.

The Benefits of FSP Models

Maximize Your Budget and Achieve Cost Efficiency

FSP helps sponsors avoid the overhead costs associated with full-service CROs, resulting in significant savings. By outsourcing only the necessary functions, sponsors can manage budgets more effectively and increase productivity. Transferring non-essential activities to the service provider offers budget predictability and reduces infrastructure costs.

Adapt Quickly with Scalable, Flexible Solutions

FSP models provide sponsors with significant flexibility and scalability. Sponsors can adjust resources based on trial needs without committing to full-time staffing. This adaptability is valuable in rapidly changing therapeutic areas where demand for expertise can shift quickly. By utilising a CRO's resources, sponsors can manage projects efficiently through different phases, ensuring continuity and maintaining quality standards. This flexibility accommodates fluctuations in workload and timelines without the sponsor incurring recruitment and training costs.

Access Industry-Leading Expertise When You Need It

A sponsor can enhance their in-house capabilities with additional expert knowledge for specific therapeutic areas or biometric functional services. Sponsors can access highly skilled teams for critical trial components, such as clinical data management, statistical programming, and biostatistics, without needing to build and maintain these capabilities internally.

Seamless Integration for a Unified Team Approach

FSP models allow CRO staff to integrate smoothly into the sponsor's team. CRO personnel are trained in the sponsor's processes, standards, and performance metrics. They work from the CRO's facilities but maintain direct connections to the sponsor's IT systems. This arrangement creates a unified team environment and reduces the impact on office space and overhead costs.

Minimize Risks with Clear Accountability

By retaining control over core trial aspects and outsourcing specific functions, sponsors can reduce risks associated with fully outsourcing to a CRO. FSP models include single-point accountability through an experienced Project Lead from the CRO. This person oversees the project lifecycle and serves as the primary contact. This setup clarifies responsibilities, improves communication, and enhances coordination, reducing miscommunication and helping achieve project objectives efficiently.

Accelerate Timelines with Dedicated and Efficient Teams

FSP models improve operational efficiency by providing dedicated teams, leading to lower turnover and enhanced team continuity. This increases productivity and speeds up timelines by reducing delays, helping bring therapies to market faster.

Gain Real-Time Insights with Integrated Technology

FSP's can integrate seamlessly with a sponsor's clinical trial management system (CTMS), enabling smooth data flow and real-time collaboration. This integration provides sponsors with immediate access to trial data, improving decision-making and oversight. Advanced tools used by FSP's can facilitate comprehensive analyses and adaptive trial designs, streamlining data analysis. This integration offers an advantage over traditional models that may delay data access until the trial ends.

Long-Term Partnerships for Sustained Success

Building strong relationships with FSP providers enhances collaboration and aligns with the sponsor's goals and processes. Long-term partnerships lead to greater efficiencies over time, as dedicated teams understand the sponsor's requirements across multiple programs. This continuity maximizes resource utilisation and contributes to successful trial outcomes.

Get to Market Faster and Stay Competitive

By streamlining operations and accelerating timelines, FSPs enhance market access by bringing new therapies to market more efficiently. This advantage is crucial in the competitive biopharmaceutical industry, where time-to-market can significantly impact a product's success.

Discover the Impact of Our FSP Model

Curious how our FSP solutions deliver tangible benefits? Explore our detailed case study to see how we helped a sponsor scale smarter and deliver faster with tailored outsourcing solutions. Learn how we can achieve the same success for your clinical trials.

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Why Partner with Us?

At Quanticate we offer a proven approach to Functional Service Provision (FSP) that ensures smooth integration, operational efficiency, and measurable results. Here's how we deliver value:

Clear Communication and Cultural Alignment

We ensure transparency at all times through detailed plans, regular updates, and open channels, ensuring issues are resolved quickly. We align with your company culture to create a collaborative, cooperative environment, while structured protocols bridge global time zone and regional gaps for seamless coordination.

Effortless Technology Integration and Training

We integrate our systems with yours to streamline operations and ensure efficient data flow. Our tailored training programs, from SOP reviews to e-learning, equip all team members with the skills they need to excel. With careful planning, we address system integration challenges and deliver scalable, reliable solutions.

Defined Roles, Responsibilities, and Governance

We bring clarity to FSP partnerships by defining roles and responsibilities through Task Ownership Matrices (TOM) and RACI charts. Our governance structures provide oversight at strategic, financial, and operational levels, ensuring alignment with your goals while mitigating risks through standardised procedures.

Performance Monitoring and Operational Efficiency

Our KPI-driven approach ensures projects stay on track, with regular performance reviews for continuous improvement. We also manage onboarding, training, and administrative tasks, freeing your team to focus on strategic priorities and reducing your operational workload.

Data Integrity and Regulatory Confidence

We uphold data integrity through standardised formats like CDISC, ensuring consistency and accuracy. With deep expertise in global compliance, including GDPR and HIPAA, we help you navigate complex regulatory landscapes, minimising risks and safeguarding data.

Flexible Financial Models and Cost Transparency

Our flexible pricing options, from fixed fees to unit-based models, align with your operational needs. We manage scope changes with clear processes to prevent budget overruns, ensuring financial transparency throughout the partnership.

Next-Gen Automation with AI & ML Integration

Using our in-house automation tools alongside industry-leading AI/ML technologies, we streamline workflows to enhance speed, accuracy, and consistency, delivering reliable results while freeing your team to focus on the research.

Over 30 Years of Specialised Expertise

As one of the world’s largest global biometric & data CROs, we bring deep technical knowledge across all phases and therapeutic areas. This expertise ensures high-quality, reliable results tailored to the complex needs of every trial.

Integrated Cross-Functional Capabilities

Our seamless collaboration across CDM, statistics, programming, pharmacovigilance, and medical writing teams ensures precise alignment and rapid issue resolution at every stage. By closely coordinating database lock timings, dataset standards, and document formatting, we improve data quality and expedite critical deliverables, enabling you to achieve faster, high-quality results tailored to regulatory and reporting needs.

Frequently Asked Questions

What Is Functional Service Provision (FSP) in Clinical Research

Functional Service Provision (FSP) is an outsourcing model in the pharmaceutical and biotech industries. Sponsors outsource specific functions or tasks to Contract Research Organisations (CROs).

FSP offers a flexible solution as sponsors determine the size of the functional support required and CROs will resource these requirements by placing their CRO staff members into the sponsor teams, who become an integrated component of the sponsor team.

This approach allows sponsors to focus on their core competencies while leveraging specialised expertise from CROs in areas like biostatistics, statistical programming, and data management.

Key Considerations of FSP vs FSO
What are the Future Trends in Functional Service Provision?

Additional Resources

Functional Service Provider Model Case Study

Functional Service Provider Model Case Study

One of the most powerful aspects for ensuring a successful relationship, and a key part of the FSP model, is the governance between the sponsor and CRO
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Hemophilia Clinical Trial Case Study

Hemophilia Clinical Trial Case Study

Quanticate has successfully worked on a Hemophilia clinical trial where biostatistical and programming support via an FSP model were delivered.
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Why Consider Functional Outsourcing by a Functional Service Provider?

Why Consider Functional Outsourcing by a Functional Service Provider?

Quanticate looks at the benefits of Functional Outsourcing and why a sponsor may consider using a FSP approach when outsourcing their clinical data
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