VANEKER CLINICAL RESEARCH SUPPORT
WELCOME
Vaneker Clinical Research Support (CRS) has a broad experience in international Clinical Research:
This varies from sponsor to investigator initiated trials, pharma, biotech and devices, ranging from phase I to IV
Specialized in the area of Oncology/Haematological Malignancies, but also experienced in several other areas
If you have any questions concerning the information on this website, please contact us.
Yours sincerely,
Vaneker Clinical Research Support
ABOUT
Vaneker Clinical Research Support
My name is Irma C.V. Vaneker.
I have a long history of work experience, after obtaining my diploma of Microbiology Analyst in 1996, I worked several years at the Laboratory of Microbiology in Enschede.
After surviving Leukemia in 1998 I started working for the Ethics Committee in Enschede as a “proefpersonenlid”.
In 2008 I started as a CRA in Clinical Research at a Pharmaceutical company. Thereafter I have worked in different roles within Clinical Research as an International sr CRA (Trainer, Site manager, Lead-CRA) with different Pharmaceutical Companies and CROs and within diverse therapeutic areas.
In 2020 I started my own company as Freelance CRA to find a more work-life balance and spend more quality time on my private life.
I am a collaborative team player, closely connected to clinical site staff and at the same time a partner with the Sponsor or CRO. Consistently exceed expectations and provide highest delivery of quality service.
You will find in me a no-nonsense, committed, approachable, analytical, pragmatic and solution seeking partner.
SUPPORT
Vaneker Clinical Research Support
Feasibility
Site selection
Pre-study visits
Initiation visits
Monitoring visits (remote ARBM/on-site)
Drug accountability
Pharmacovigilance and Safety
Set up and maintenance of the study file
Close-out visits
Site Management
Co-monitoring and training visits
Review monitoring visits
Writing SOPs, Monitoring Plans
Creation of other monitoring documents and tools
Central and local IEC (METC) submission
Writing of (country specific) patient information and informed consent
Contract negotiation with sites and/or vendors
Development patient recruitment plans
Organization of start-up meetings
Audit preparation
GCP training, including European clinical trial directive and Dutch legislation
SOP training
Coaching
EXPERIENCE
Therapeutic Indications:
Early Clinical Development (Phase I): Oncology – Solid Tumors, Haematological Malignancies
Phase II-III:
Oncology/Hematology – Leukemias and Lymphomas
Solid Tumors
Antibacterial Vaccine (FDA approval study)
Immunization Trial in Adults
Pharmacokinetics of Anticoagulant Therapy, Influenza Vaccine, Hemophilia, Cardiovascular Device
Immune Mediated Inflammatory Diseases, CardioMetabolic and Infectious Diseases, Neurology, Dermatology
Immunology COVID-19 related severe pneumonia
Phase IV: Glaucoma Medical Device
Countries: The Netherlands, Belgium, Luxemburg, Germany, UK and US
Lead-CRA: The Netherlands, US and Germany
Language Capabilities: Dutch, English and German
"As an experience expert I know what it is to be a cancer patient, this makes me even more involved in my work as a Clinical Research Professional"
Irma C.V. Vaneker
CONTACT
Would you like to obtain more information about our services, please contact us at irma@vanekerCRS.com or +31 (0) 6 421 422 32
+31 (0) 6 421 422 32
KvK 80716571 | BTW-ID NL003484000B02