I am independent CRA-Consultant in investigation, clinical consultancy and regulatory affairs consultancy in Advanced Therapy Medicinal Products (ATMP), working for pharmaceutical, clinical companies and CROs to carry out its projects with the highest quality and inside the due period.

I am focused in those clients that its presence in local and EU is limited or absently and that a reliable source and loyal partner need.

I understand that, despite the fact that clinical research is a business that grows in the same regulatory framework, each client has different needs. Therefore, I adapt to customers and their needs with a personal approach. Working with the international standards of quality, which is not only applicable to all the services I offer, but I also think in the project and the objectives of the client.

Specialties: Quality consultancy across the country and the EU (GCP audits, process audits, supervision visits, protocols, regulatory...) and clinical operations in Spain (supervision, regulation, pharmacovigilance, local representative).

Therapeutic Areas: ATMP, oncology, neurology, cardiology, rare diseases, ophthalmology.

Experience and clients: relations with local and EU companies (CROs and biotech) in studies and clinical trials.

I am at the disposal of the customers for supplying them the needs they seek.

• Monitor the conduct of clinical trials, especially enrollment and quality of data.

• Verify subject safety and site adherence to FDA Regulations and ICH/GCP Guidelines.

• Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.

• Review CRF, Informed Consent Documents and query language/narratives.