First time in human study

The first-time-in-human study represents a critical development milestone. We have helped numerous small and medium enterprises overcome the many hurdles involved in successfully initiating and completing these studies on time, on budget and compliant with regulatory requirements.

Our team can help:

• Advise on and develop the required company standard operating procedures you need to run clinical studies.
• Provide information on different study designs (including adaptive studies) and give advice on issues surrounding practicality and feasibility.
• Consult with you on various options for the placement of your study.
• Write and/or review documents central to the conduct of your study, including those required for regulatory and ethics submissions.
• Coordinate and manage agency submissions.
• Manage and/or monitor your study from concept through to conclusion.
• Ensure prompt reporting and provide advice on the best means of managing embryonic ‘awareness and expectations’ to maximise return-on-investment strategies.