FOUNDER
BIO
Monique Wouters started working in Clinical Research in 1994, with positions as Clinical Data Reviewer, Scientist Clinical Pharmacokinetics (PK), Project Manager Biometrics, Data Review Coordinator and Global Biometrics Phase I-II Manager, both in the pharmaceutical industry (Janssen) and in a clinical research organization (SGS).
In 2007, Monique Wouters founded W&D Consulting, providing high-quality services, mainly as clinical pharmacokinetics scientist and as QC reviewer of modeling reports.
Monique holds a MSc in Physical Education from State University, Ghent in Belgium, and followed multiple training courses in pharmacokinetics, statistics, medical writing, etc…
STRENGTHS
Clinical Pharmacology
Major strengths are the extensive experience in clinical pharmacology, expert medical writing skills, a high level of quality, respect for timelines, and experience across the biometrics subdivisions data management, clinical pharmacokinetics, medical writing and pharmacometrics. The focus is always on accuracy, clarity and simplicity.
Quality Control
Over the years, Monique has gained a reputation as expert in quality control review. Some of the world’s leading pharmaceutical and pharmacometrics consulting companies are relying on W&D Consulting as their preferred external partner for QC review. Typically, reported results are fully traced back all the way to source data, and a report QC does not only include a check of consistency versus analysis outputs, but also checks of data files and analyses.
Pharmacometrics writing
Good pharmacometrics writing requires the rare combination of expert medical writing skills and knowledge of model-based analysis concepts, pharmacokinetics, pharmacodynamics, statistics, data management, health authority regulations, etc. These are exactly the fields of expertise of Monique and she is therefore your best placed partner to assist with pharmacometrics writing, while you, as the modeller, can focus on the analyses.
Standardization
Monique strongly believes that increased quality and efficiency starts with standardization. Companies that challenge their processes and standardize where possible, while allowing flexibility for adaptation, significantly increase the quality of their end-products and reduce costs. Being familiar with processes across the biometrics subdivisions, Monique has led several projects for optimization and harmonization of various templates and processes.
