Welcome to In2Clinic
In2Clinic is a consulting company for drug development. The company was founded by Mireille Gerrits, a pharmacist and clinical pharmacologist with a strong scientific background in early clinical drug development and over 25 years experience in the pharmaceutical industry. Until 2014 Mireille worked as Director Clinical Pharmacology for Merck in Oss were she participated in clinical development programs in different therapeutic areas. Before that she worked as a project manager, medical writer and quality manager for a phase 1 CRO in the Netherlands. Mireille holds a master’s degree in pharmacy and a PharmD from the Utrecht University in the Netherlands and is a certified clinical pharmacologist.
Services
Clinical Pharmacology
- Advise for early clinical development strategies from first in human studies through Proof of Concept.
- Preparation of early clinical development plans and translation of pre-clinical results to strategies for clinical development.
- Development of clinical pharmacology strategies during late stage development.
- Clinical pharmacology support for post-marketing changes such a new formulations or additional indications.
- Design and analysis of clinical trials, especially phase 1/2a clinical trials and other clinical pharmacology trials, including ethnic sensitivity, thorough QTc, drug-drug interaction, paediatric, bioavailability and bioequivalence trials.
Medical Writing
- Preparation of study and project related documents such as study protocols and reports, Investigator’s Brochures, Informed Consents and safety reports.
- Preparation of documents for regulatory submissions e.g., Common Technical Documents, Investigational New Drug and New Drug Applications.
Project management
- Project management for Clinical Pharmacology programs
- Study management for phase 1/2a and other clinical pharmacology studies.
