Early stage startups often do not have the permanent in-house staff to conduct all aspects of a clinical trial, especially where the trial involves many sites and multiple countries. Choosing a CRO that can stand as an extension to your team, scaling services up or down as needed, can be a great advantage at this stage.
Your company would need an experienced and capable service provider to ensure knowledgeable partnership. Quality monitoring, data processing and analysis is critical for the overall success of the clinical trial. proven track record is usually a promising sign.
For startups, bigger may not always be better. Small to mid-size CRO’s can offer better strategic partnership having deeper niche areas of experience. Your chosen partner should manage a professional team with senior management that will be at your service as needed throughout the clinical path.
A clinical trial should follow industry regulations and unified Standard Operation Procedures (SOP’s) ensuring that the company is working in compliance with GCP and 21 CFR part 11.
Naturally, costs will be a key factor when choosing your partner and it may be tempting to choose the lowest bid. However, it is worth remembering the following:
- The most transparent detailed proposal will keep you less surprised
- Compare “apples to apples”
- The services required for your trial are available to the partner and can be easily implemented (e.g. randomization, inventory management, EDC, etc.)
Ultimately, the CRO you choose will have a significant impact on the success or failure of your plan. Partnering with experts that understand your company’s challenges and creating a partnership of knowledge and trust will help you to achieve your goals – be sure to choose wisely.