Clinical Development

Advising, designing, writing or reviewing:

  • Clinical development plans
  • Biomarker strategy
  • Clinical protocol synopses and¬†protocols
  • Clinical reports/publications
  • Clinical expert reports
  • Investigator brochures
  • Ad hoc clinical documents for FDA/EMA submission (eg: pre-IND, IND)

Clinical Safety

Reviewing or Advising:

  • Individual AE/SAE reports
  • Study safety results interpretation
  • Periodic regulatory safety updates

Regulatory Strategy

Reviewing or Advising:

  • Ad hoc interaction with regulatory authorities (eg: FDA, EMA)
  • Conventional or Accelerated submission
  • Region or country selection¬†
  • Phase 1B/2 objectives definition

Project Evaluation

Reviewing or Advising:

  • Preclinical package to enter in human
  • Early clinical data to progress to the next step
  • Preclinical or clinical data for in-licencing program

Problem Solutions

Reviewing or Advising:

  • Design of functions for early clinical development organisations
  • Site selection
  • CRO selection

Training and Lecturing

Reviewing or Advising:

  • Preparing presentations for internal, external or scientific meetings
  • Discussing protocols with potential investigators
  • Training and lecturing on topics especially related to clinical drug development, study design, good clinical practices (GCP), drug safety and pharmacovigilance.

Literature survey

  • Internal decision making purposes
  • Background for publications
  • Medical information material