Services provided to clients

Clinical Team Lead Management/Interim management at local level

Medical Science Liaison (MSL)

  • Rheumatoid Arthritis study phase I, European (West and EEC) biosimilar study, globally-focused biopharmaceutical company 2018 (heading up team of 5 MSLs)

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 
  • (Ultra) Rare diseases (Hematology, Muscle and Neuropathy Diseases) phase I-III Global studies, growing biotech company since 2019 
  • Phase I, Bio-Analytical, Quality Assurance & Regulatory Affairs for growing biotech company since 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 with creation of Blue Box Pack (Combination Pack), Promotional and Non-Promotional Materials, Standard Operating Procedure (SOP) - pharma company 2018-2021
  • 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

Data Projection Officer (DPO)

  • Trained on DPA for the Netherlands