Necessary resourcing models used for the clinical studies and they have their own pros as cons. These models are described as below:
- In-house resourcing model:
In in-house resourcing model, sponsoring organizations have their own internal employees and contractors making contracts directly within the company to execute all the function of the clinical study. Data management, study conduct, administrations, statistics and all the functions involved in clinical studies are conducted in-house by the internal employees and by the contractors that sponsor organizations take on internally.
- Familiarity is the biggest strength of this model as having all the staff internally and they are completely familiar with the processes of the sponsor organizations, their culture, decision making and tools. Familiarity within this model speeds up the study because they do not require any training.
- The coms of in-house resourcing model is that the tendency of doing the same thing over and over without any changes by the same people running different studies within organization.
- There is no flexibility to scale up and down very quickly by in-house model within organization and for the study.
- This model is costly for the studies by having full time employees running all the studies.
- Fully outsourced model:
According to this model, sponsors pay different CROs and vendors to run all the aspects of their clinical study.
- This provides an ability to scale up and down quickly depending upon the resourcing needs because CROs already have sufficient number of dedicated staff to run studies for different sponsor organization.
- This model can be less costly for the studies depending upon the objectives, timeframes and actual CROs.
- Ability to tap into the expertise that is not available in-house.
- Adding extra layer as a third party for the study between processes, sites, decisions and approval. Sponsor organizations should be prepared and aware of it appropriately for the issue that can arise.
- There can be cultural difference in outsourcing model because it adds up the cultures of the CROs along with the sponsor’s culture.
- Hybrid or FSP model:
According to this FSP model, sponsor organizations use their internal employees and contractors for some specific part of the study along with third party vendors performing rest of the functions.
- This provides an opportunity to the organizations to overcome weak parts of their studies by hiring third party vendor for those functions. This helps them to conduct their studies more efficiently.
- There is no need to utilize third party processes because these are used only for some functions.
- Adding a level of layer whether it is for one function but the sponsor organization should remain aware for that.
- Ignoring formal oversight plans when using FSP model. This turns into lack of visibility into their deliverables, processes, issues and risks.