What is Functional Service Provision? 


Functional service provision is a service model where a company is contracted to deliver services or specialised resourcing support for another organisation. Widely used in the pharmaceutical, biotech, and medical device industries, the functional service provision model offers a flexible approach to clinical research. Instead of fully outsourcing their clinical trials, companies can select specific services from a range of options, allowing them to retain control over most aspects of the trial while benefiting from expert support in key areas.
 
What are the benefits of using a Functional Service Provider (FSP)? 
  • For early-phase clinical development, using a Functional Service Provider (FSP) proves to be an effective and economical solution. 
  • FSPs provide essential resources and specialised expertise that may not be readily available within an organisation. 
  • Due to delays in hiring processes or budget constraints, partnering with an FSP can be an effective way to outsource specific services while allowing a company to concentrate on their core research, development, and business activities.
Using OCS Life Sciences as your Biometrics FSP 
The functional service provision model for biometric services is beneficial even for companies that typically hire biostatisticians internally or maintain dedicated data management and biostatistics teams. It offers the opportunity to have certain biostatistical components validated by external experts. At OCS, we offer comprehensive end-to-end biometric solutions, which can also be provided individually through our functional service provision model. 

Rather than outsourcing an entire clinical trial, companies can opt to outsource specific biometrics services or resourcing support to OCS. This flexibility allows our consultants to support your organisation for a set period, either working independently or as an extension of your existing team to provide additional capacity. Whether on-site, off-site, or in a hybrid setup, our consultants integrate seamlessly with your operations. OCS takes full responsibility for the outcomes, ensuring high-quality results. With a team of over 30 experts, we bring a wealth of knowledge and specialised expertise to the table, delivering high-value solutions that enhance the statistical reporting of your clinical trials. 

For example, OCS has provided standalone CDISC SDTM data conversion services to clients, enabling them to manage the remaining data conversion and biostatistics processes, such as ADaMs and TLFs, on their own. This flexible approach allows companies to tap into specialised expertise without the need to overhaul their existing processes. 

In summary, integrating an FSP addresses the need for comprehensive biometrics support while allowing pharmaceutical and biotech firms to focus on other critical activities. This strategic outsourcing approach not only enhances operational efficiency but also accelerates the path to market for drug candidates. 

Do you want to find out how our FSP solution can be suitable for your project?


Then get in touch with Erik Hamminga through the button below or at erik.hamminga@ocs-consulting.com