Biotechnology’s Trusted Partner from Start to Finish
Aixial Group’s team of clinical experts can support your biotechnology company in the early phases of clinical development and through study execution Clinical Development Expert Consultancy
Our team of subject matter experts can support your clinical development planning in the areas of regulatory, medical/safety, data analytics, and clinical operations.
We can also define elements of the Target Product Profile (TPP) including the indication, population, study design and dosing schedule for first-in-human clinical trials based on:
- Pre-clinical data, literature and discussions with Key Experts/Opinion Leaders
- Pre-clinical and regulatory gap analysis
- Synopsis and protocol design
- Discussing strategy and study design with Regulatory authorities (e.g., scientific advice meetings, protocol advice, pre-IND meetings, etc.)
- IND and CTA submission
- Expert Guidance and Support for IND Filing
Aixial Group can provide the guidance and support required to create the regulatory plan, filing tracker and timeline to ensure a successful submission. This includes support during the review period, including correspondence with and meeting representation with the agency as needed.
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