Determining whether to conduct clinical trials in-house or outsource the task to a contractor requires careful consideration. We must weigh the pros and cons of expenditures versus potential advantages.
- More flexibility
- Increased in-house knowledge
- Lower potential for communication issues
- Possibly more expensive
- Requires time and resources to develop in-house expertise
If you decide to conduct clinical trials in-house, it’s important to have the infrastructure set up to support them. This requires both physical resources (Do you have the physical space to conduct trials? Do you have the machinery?) and human resources (Do you have in-house expertise, or would you need to hire/train personnel to conduct the trials?). You will need staff who are scientifically-focused, and who are familiar with the industry requirements, such as geographical regulations and working with different government agencies.
You must also consider the timeline involved: getting fully set up can take years. It is important to set out a list of requirements with associated timelines for completion. Remember that many of the steps can take months. Determine the critical milestones in the project, such as acquiring a contractor to set up the physical space (for example if you need to build Controlled Temperature Chambers) and applying for the appropriate licenses. You will need a designated project manager to set out timelines and determine which activities can be run concurrently. Also consider whether you would train existing staff or need to hire new personnel who would require less training.
If you have a long-term project or multiple projects, it may make sense to build the capabilities to run clinical trials in-house.
- Systems are already in place and compliant
- No need to invest in resources
- Accelerated project timelines
- The potential for communication difficulties
- Less opportunity to develop in-house expertise
Outsourcing should be considered if you do not have the capabilities to run clinical trials already in-house, and the project isn’t long-term or recurring. Using an external agency means they are able to guarantee they can meet regulatory requirements and that they are fully licensed to run the trials. They are also able to immediately take on a new project, so your trial timeline is accelerated.
When choosing an outsourced company, it is still important to create a process map to mark milestones. Choose at least three companies to vet for their qualifications before making a decision, so you have some options in case one turns out to not be viable. Then consider: is the company conveniently located for you to do business with them? Are they in good financial standing? Do they have the physical capabilities you require, such as a temperature-controlled facility, packaging and labelling infrastructure, and experience exporting products? Most importantly, you must feel confident that they have the scientific knowledge required. Do a complete audit of each company to determine their compatibility with your needs, and how they compare to the other companies you are considering.
In terms of milestones for this project, make sure you have a set date to receive project proposals from each company. Next, select the vendor, and ensure you have the proper protocols and government permits in place on your end. Confirm a cost estimate and establish communication channels between your company and theirs.
Whatever option you choose, ensure that you are clear on timelines and requirements to achieve your clinical trial goals.