Planning the drug development:
- Pre-clinical into First in Human (FiH) and phase I/II Proof of Concept (PoC) studies
- Clinical concepts: phase I-IV, non-interventional and Investigator-initiated Studies (IIS), seamless and adaptive Ph1/2, Ph2/3 designs, Early Access Programs (EAP), Compassionate Use, Pre-License Supply
- Protocols and Clinical Study Reports, publications
- Investigational New Drug Application (IND) & Clinical Trial Application (CTA), New Drug Application (NDA ), Marketing Authorization Applications (MAA), Accelerated Approvals (AA)
- Electronic Data Capturing (EDC) systems development including data integrity check