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.

It’s never too early to talk to us and we’re always here to help! Don’t struggle, email us at: info@aixial.com