At Aepodia, when we support your projects we prepare all the regulatory documents required for a clinical study in collaboration with our consultants.
We provide or review all the documents needed for your clinical study according to GCP guidelines.
We coordinate writing and reviews and send regular updates to the sponsor as part of our services.
- Investigator’s brochures
- Investigational Medicinal Product Dossier (IMPD or IMP)
- Clinical study protocols
- Clinical study reports
- Design of early preclinical or clinical development plans
- Informed consent forms
- Benefit-risk assessment reports
- Abstracts and journal articles