Regulatory Analysis

Fundamental to the success of clinical studies is a strong project team who can identify and mitigate possible risks, and this is exactly what Accelagen provides. Our team is a collection of highly experienced specialists in their field who go to any length to ensure that your project is set up for success from the start. That means critical assessment of study information, including scientific data, in the ‘Initiation’ stage where we use our extensive industry knowledge and regulatory  expertise to identify gaps and areas to address before we move forward. Through this critical analysis, we look at all ways to ensure the scientific data will withstand the rigour of evaluation, supporting the positive approval. As part of our trial setup process, you can be confident in us preparing and submitting the highest quality regulatory documents to the appropriate regulatory authority, and IRB (Institutional Review Board) or Human Research Ethics Committee.