About

Mary Cardone, BHSc

Delve Medical Writing was established in February 2017 by Mary Cardone.

Mary has worked in the clinical research industry since 1999 in a variety of roles including:

  • Director/Medical Writer for Delve Medical Writing since February 2017;
  • Senior Medical Writer at INC Research Australia (8 years);
  • Clinical Research Associate at Omnicare Clinical Research
    (4 years);
  • Clinical Trial Coordinator at CMAX (phase 1 study unit)
    (3 years);

Mary’s CV can be provided on request.

You can view additional details about Mary’s industry experience by visiting her LinkedIn page.

Monique joined Delve Medical Writing in October 2018 as Principal Medical Writer.

Monique has been preparing scientific documents since 1996 in the following roles:

  • Principal Medical Writer for Delve Medical Writing since October 2018;

  • Clinical Program Manager at Neuroscience Trials Australia
    (1 year);

  • Manager, Medical Writing at INC Research (3 years), Senior Medical Writer (8 years);

  • Clinical Research Associate at Acrux Pty Ltd (2 years);

  • Clinical Trial Coordinator at Peter MacCalum Cancer Centre (3 years);

  • Research Fellow/PhD Student at University College London for 5 years.

Monique’s CV can be provided on request.

You can view additional details about Monique’s industry experience by visiting her LinkedIn page.

Monique Anderson, PhD

Monique Anderson, PhD

Monique joined Delve Medical Writing in October 2018 as Principal Medical Writer.

Monique has been preparing scientific documents since 1996 in the following roles:

  • Principal Medical Writer for Delve Medical Writing since October 2018;

  • Clinical Program Manager at Neuroscience Trials Australia
    (1 year);

  • Manager, Medical Writing at INC Research (3 years), Senior Medical Writer (8 years);

  • Clinical Research Associate at Acrux Pty Ltd (2 years);

  • Clinical Trial Coordinator at Peter MacCalum Cancer Centre (3 years);

  • Research Fellow/PhD Student at University College London for 5 years.

Monique’s CV can be provided on request.

You can view additional details about Monique’s industry experience by visiting her LinkedIn page.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines ensure there is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

Based on extensive experience in the clinical research industry, Delve has a strong understanding of these guidelines resulting the efficient production of clinical trial documents for successful and timely submission to ethics committees to ensure studies are up and running quickly and smoothly at investigational sites.

Clinical trial documents prepared by Delve adhere to the integrated addendum to ICH E6 (R1):
Guideline for Good Clinical Practice E6 (R2)

Clinical Study Reports prepared by Delve adhere to ICH E3:
Structure and Content of Clinical Reports

Early phase studies require adherence to specific guidelines that are unique. Delve specialises in this niche area of clinical trial writing.