For smaller pharmaceutical, biotech and medical device companies, many have to grow their teams quickly as their clinical trial takes shape. There is a debate in the industry as to whether companies should hire full-time employees (FTEs) or work with the array of experienced consultants available to sponsor companies.
Just by exploring LinkedIn, what’s evident is that more and more experts in the clinical operations field are ‘flying solo’ and becoming clinical consultants. The critical question to ask here is whether this is to the benefit of the industry or does it create a more fragmented approach to clinical trials?
In small pharma hubs such as San Diego, Boston and the Bay Area, companies are constantly upsizing, downsizing, disappearing, and merging, which means sponsors and potential employees alike have to be agile and flexible to ensure success.
Working with consultants is typically seen as the more costly approach (from an upfront cost perspective), but has many advantages. The ideal consultant will be able to provide not only their services, but importantly their experience and their contacts. If managed correctly, consultants should be seen as an extension of the company team and be encouraged to provide input on protocol, feasibility and outsourcing decisions.
When working on a larger scale trial, which would be expected to take place over a relatively long time, hiring full-time employees seems to be the most practical approach. As well as often being the cheaper option, this strategy will enable the sponsor to train employees to carry out tasks according to company policy. Many people believe that having a team of permanent staff also promotes more enthusiasm in the trial; they will have more of a vested interest in the results of the trial, and are often more incentivized to see the trial achieve its budget and timeline requirements.
Many companies in the past have carried out cost-analyses of these two different approaches and oftentimes the differences were not too great when all aspects were considered. However, there are many issues that cannot be accounted for in quantifiable way, such as employee buy-in to a trial as mentioned above, as well as the complications and issues when reaching the end of a trial, or if the results of the trial were not positive. Once you hire a full-time employee there is a sense of ‘being stuck with them’ when, for whatever reason, their role may no longer be required.
In reality, most sponsor companies often work with a mixture of FTEs and consultants so there needs to be a discussion within sponsors regarding which projects should be assigned to FTEs and which to consultants. If there are constant tasks that need to be given to a specifically skilled consultant every so often, many companies encourage their consultant to become a Subject Matter Expert.
Whichever choice companies make, sponsors need to ensure they are flexible and able to take a multipronged approach to team formation. In such a fast-paced and changeable landscape, such as that of clinical trials, companies need to adapt to change and not be restricted by ‘company protocol’ when it comes to assigning tasks to particular parties.
This responsibility does not purely lie with the hiring powers at trial sponsors – potential full-time employees and consultants alike need to take a flexible approach when working at a sponsor company, ensuring they are bought into trial outcomes and ready to take on a variety of tasks that may come their way.