Supporting your pipeline needs with a cost-effective and high-quality solution.
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.
At Quanticate, our Functional Service Provision (FSP) models deliver specialised services tailored to ensure trial integrity, regulatory compliance, and reliable outcomes.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Combining data services under one provider offers significant advantages. As a niche biometrics CRO, we integrate biostatistics, statistical programming, data management, and medical writing, providing a cohesive approach to data handling.
Streamlined Communication: Managing all data services with us simplifies communication and ensures aligned objectives.
Consider a large sponsor conducting a multi-phase clinical trial requiring extensive data analysis and reporting. By partnering with a niche biometrics CRO:
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.
By forming an FSP relationship you will receive:
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
As one of the world’s largest global biometric & data CRO’s, 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.
Our seamless collaboration across CDM, statistics, programming and medical writing teams ensures precise alignment and rapid issue resolution at every stage. By closely coordinating data base 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.
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.
In clinical trial outsourcing, sponsors choose between two main models: Functional Service Provision (FSP) and Full-Service Outsourcing (FSO). Choosing between FSP and FSO depends on your clinical trials needs and objectives. By evaluating your resources, desired level of control, and the specific demands of the trial, you can select the outsourcing model that best supports your aims.
Allows sponsors to retain control over key functions while outsourcing specific tasks to specialised providers. This model is more tailored and cost-effective. Sponsors can access specialised expertise without giving up control of the entire trial. FSP offers flexibility in scaling resources, enabling sponsors to respond quickly to peaks and troughs in their workload.
Involves handing over the entire management of a clinical trial to a CRO. This model offers simplicity and a single point of contact, appealing to sponsors who prefer to outsource all trial aspects. However, FSO can be more expensive and less flexible, potentially limiting the sponsor's control over specific trial components and overall strategy.
The future of Functional Service Provision (FSP) in clinical research is evolving, with several trends shaping the industry:
Innovations in data analytics, artificial intelligence (AI), machine learning (ML), and cloud-based systems are expected to enhance FSP capabilities. These technologies enable FSPs to provide more advanced data management, statistical analysis, and real-time trial monitoring which increases the efficiency and accuracy of clinical trials.
The development of hybrid FSP models is enhancing flexibility and customisation in outsourcing strategies. Sponsors can adjust their approaches to meet the specific needs of each clinical trial, combining control with outsourced expertise.
As clinical trials expand worldwide, Functional Service Providers are playing a more important role in managing studies across multiple regions. FSPs with strong global capabilities can help sponsors meet local regulatory requirements, overcome language barriers, and manage sites across different areas.
With more digital data handling, there is a growing focus on data security and regulatory compliance. FSP models are evolving to include strong data protection measures, ensuring that sponsors meet regulations like GDPR in Europe and HIPAA in the United States.
The demand for real-time data access is increasing, especially as decentralised and hybrid trial designs become more common. FSPs are using advanced data integration and visualisation tools to give sponsors immediate access to trial data. This improves decision-making speed and enhances trial oversight.
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