Services provided to clients
Clinical Team Lead Management/Interim management at local level
- Vaccine study to evaluate 13-valent pneumococcal conjugate vaccine (PCV13) for the prevention of vaccine-type invasive and noninvasive Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA), Netherlands, 2009
- Study management 15-20 CRAs, monitoring the CAPiTA study (http://clinicaltrials.gov/ct2/show/NCT00744263?term=vaccine+and+capita&rank=6; )
Medical Science Liaison (MSL)
- Rheumatoid Arthritis study phase I, European (West and EEC) biosimilar study, globally-focused biopharmaceutical company 2018
Project Management
- Ophthalmology study (Dry Eye Disease (DED)), phase II, IND US study, biotech company 2018-2019
- Oncology study (Bladder Ca phase II), CRO-Research Foundation EU 2010-2014
Outsourcing Support (strategic consultancy & hands-on)
- CNS (Multiple Sclerosis) phase III Global biosimilar study, mid-sized pharma company 2010-2012
- Oncology study (Breast Ca) phase III Global biosimilar study, mid-sized pharma company 2012
- Oncology study (Bladder Ca) phase II and (Prostate Ca) phase III, CRO-Research Foundation EU 2010-2014
- Oncology, Immunology, Autoimmune & Neurological Diseases phase I-III Global studies, small biotech company 2019
Business Proposal –Writing and Negotiations
- Oncology study (Bladder Ca) phase II, CRO-Research Foundation EU 2010-2014
Outsourcing and Vendor Management Support (tactical and strategic consultancy)
- Medical Device company, Global 2009-2016
- Studies in different phases
Class III, CE-Mark, Investigational Feasibility, Pre and Post Marketing in the following areas:- Urology & Women’s Health, Endoscopy, Neuromodulation
- Cardiovascular (Interventional Cardiology (TAVI, TAVR, coronary eluting stents)
- Peripheral Interventions (eluting stents)
- Rhythm Management (ICD, CRT-D devices)
Advise PMCF study
- Advise on Post Market Clinical Follow-up (PMCF) study (MEDDEV 2.12/2 Rev 2), Medical Device company EU 2017
Regulatory Affairs
- Creating Clinical Trial Applications (CTA)
- Support Study Start-up: - submissions to Competent Authority (CA) and Medical Research Ethics Committees (MRECs) phase II-III project in Metabolic disorder in the Netherlands, biotech company 2019
- Support Study Start-up phase III project in Gene Therapy in the Netherlands, biotech company 2019