When a drug or medical device candidate is ready for clinical investigation, organisations have the choice to utilise three common clinical outsourcing models, allowing them to leverage the expertise and resources of external, dedicated service providers. The three most adopted outsourcing models used for clinical trials are:
This model means that the entire clinical trial process is outsourced to a contract research organization (CRO). The CRO then would take responsibility for the design, planning, execution, and management of the trial. They handle all aspects of the trial such as site selection, patient recruitment, data collection and analysis, regulatory compliance, and monitoring.
Full-service outsourcing provides a comprehensive solution, allowing the trial sponsor organisation to streamline their internal functions, and focus on future candidate development or commercialisation.
The Full-Service Outsourcing market is dominated by a few multi-national players; IQVIA, Parexel, Icon, PPD by ThermoFisher – to name a few. In the past few year’s mergers and acquisitions in the CRO space has progressively changed the market.
Functional Service Provider
More commonly abbreviated to FSP, in this model specific functions are outsourced to specialised service providers. Instead of outsourcing the entire trial, the trial sponsor would select certain areas where external expertise is needed. For example, the sponsor may outsource activities like data management, clinical supply, patient recruitment, or monitoring to different vendors.
The FSP model offers the trial sponsor more flexibility, also allowing to retain control over some aspects of the trial while leveraging external capabilities in targeted areas.
The hybrid outsourcing model combines elements of both full-service outsourcing and the FSP model. In this approach, the trial sponsor works closely with a CRO for overall trial management and execution while maintaining some functions in-house. The sponsor and CRO work together to determine the division of responsibilities, with the sponsor retaining control over certain critical activities such as project oversight, data analysis, or medical monitoring.
This model can provide a balance between external expertise and sponsor control. From speaking with trial sponsors recently, the hybrid outsourcing model is gaining popularity, with many choosing to bring project oversight and management of CRAs in-house to retain control of the overall clinical trial.
When identifying an outsourcing model, and potential collaborators for a clinical trial, a trial sponsor can be influenced by several factors. Whilst these may vary depending on the size, funding and in-house capabilities of the trial sponsor, five key considerations are:
Value for $$$
One of the primary factors in the decision-making process for outsourcing, not just clinical, is cost-effectiveness. Trial sponsors will evaluate the overall costs associated with conducting clinical trials, including site selection, patient recruitment, data management, monitoring, and regulatory compliance. These costs will then be compared to working with a full service CRO, verse FSP or Hybrid models, to consider which option provides the best value for money.
Resources & Expertise
When starting a trial, trial sponsors will firstly assess their internal capabilities and resources to determine if they have the necessary expertise and infrastructure to conduct the trial independently, or in part of a Hybrid outsourcing model. If they lack specific expertise, experience, or resources required for the trial, outsourcing to a full-service CRO, or enlisting the expertise of multiple vendors in a FSP model may be a preferred option. External service providers typically offer experienced staff, and established systems and processes for efficient trial management.
The speed and efficiency of clinical trial execution can be critical, especially in competitive therapeutic areas. Trial sponsors may consider whether outsourcing can help accelerate trial timelines by leveraging the external vendor’s existing network of investigators, established relationships with sites, and streamlined processes. A CRO will have the ability to initiate trials more quickly and manage them efficiently, leading to faster completion, data analysis, and submission for regulatory approvals.
Depending on therapeutic area, diversity considerations, or disease prevalence, the clinical trial may need to be conducted in multiple countries. For such trials, it is common for trial sponsors to enlist a global CRO with local presence and regulatory expertise in the specific target areas. Local CROs and vendors may be selected for trials specific to a particular country where they have deep knowledge of local regulations, cultural considerations, and patient recruitment strategies.
It is often extremely risky to run a clinical trial. Trial sponsors will evaluate the risks associated with clinical trial management and often outsourcing enables them to mitigate those risks. Service providers often have well-established quality assurance and risk management processes in place, reducing the sponsor's burden of ensuring compliance with regulations, data integrity, and patient safety. By partnering with a CRO or specialised service providers, sponsors can leverage the experience in managing risks, handling regulatory inspections, and navigating complex trial requirements.
In summary, there is no right nor wrong way to approach outsourcing for a clinical trial. Each trial sponsor organisation will be faced with varying complexities specific to the trial’s design, patient catchment, regulatory considerations, and risk assessment.
The clinical outsourcing market is in a state of constant evolution with providers launching new offerings, consolidations and acquisitions, as well as technology playing and increasing role in clinical trial execution.