Clinical Development

Your data is progressing well, your team is growing, and your company culture is evolving. As you add more discipline, you're starting to capture attention. With your assets or products advancing through the stages and moving closer to regulatory approvals in the U.S. or Europe, you may find the need to outsource certain tasks.

A growing pipeline and ongoing R&D in additional therapies may require a thorough Quality Management System (QMS) assessment to ensure data integrity, participant safety, and trial reliability. Regulatory agencies inspect these QMS systems during the approval process to confirm that clinical trials meet the required quality and compliance standards. This involves assessing processes for monitoring and auditing clinical trial activities, identifying deviations from protocols or regulations, and taking necessary corrective actions.

Halloran can assist in preparing your IND and provide comprehensive lifecycle support from IND to BLA/NDA submission. We review applications to assess the risks and benefits associated with the proposed clinical trial. Upon approval, researchers can conduct the trial adhering to the approved protocol and regulatory guidelines. If you're thinking about inspection readiness, we can help you prepare. Whatever your clinical needs, we have the expertise to be your trusted partner.