Overwhelmingly, our clients tell us that the primary challenges of the preclinical phase are costs and time. This phase can go on for years, with all the financial investment that entails. It’s important for our clients to determine as early as possible in the process whether it’s worth it, through technical and market research. Early testing and data reporting often happen across language and culture divides, so there needs to be a cost- and time-effective way to make that process work. And likewise for market analysis.
Once they come out the other side of this research and have established going to trial is a worthwhile exercise, they need to get the approvals to do so from relevant ethics and regulatory bodies. Depending on where these bodies are located, translation can become a major factor in communicating clearly and providing documentation in appropriate languages. Requirements can also differ depending on where the ruling bodies are based, so experts on local regulation can make a big difference.
And then they need to turn their preclinical findings into successful trials, which can be one of the most complex transitions in the drug development process. A key factor here is getting the protocol right for all participants, whether that’s through seeking their input during design, or translating the final protocol for their understanding.
