Quality of clinical data, competitive timelines, and cost-effectiveness. These are just some of the numerous considerations that Biopharma and MedTech companies need to think about when conducting clinical studies. 

Creating high-quality clinical data facilitates good clinical development decision-making, enhances the quality of a drug Marketing Authorization Application (MAA) dossier, and mitigates long-term regulatory vulnerabilities. Shortcomings in the clinical data that support MAA dossiers can potentially result in unreliable outcomes, sometimes leading to entire clinical studies needing to be redone.

Mitigating risk in Phase I trials

Phase I clinical trials are especially susceptible to these outcomes due to their short-term duration. Deficiencies in the clinical trial that result in poor quality clinical data can jeopardise the integrity of the entire MAA dossier. Choosing a clinical site and a CRO with an excellent track record of audits and a commitment to maintaining the highest standards to achieve data quality is not just a strategic decision, but a safeguard against setbacks in clinical development.

Getting Phase I trials right the first time is crucial for lean and effective drug development. This approach prevents the doubling of costs, (both opportunity and financial), and equally importantly avoids the duplication of drug exposure for study participants.