VivMedical - Consulting
"Think up, under, left, right, everywhere but in the box "
CV
Main Education
- VWO Bernardinus College /Netherlands / 1988
- Healthsciences University of Maastricht / Netherlands /1989 (bridging year)
- Internship Pediatrics & Genetics, University of Oxford -UK /1995
- Flexibel MD degree (MSc) in pediatrics, gynaecology / and genetics University of Maastricht - Netherlands /1996
- Traditional MD degree University of Maastricht- Netherlands /1999
- Registered Clinical Pharmaceutical Physician (NVFG) – Netherlands /2002
- PhD degree Universtiy of Maastricht – Netherlands / 2004
- Registered Physician at the Orde Der Geneesheren – Belgium / 2010
- CPI (APCR) – USA / 2011/2013
- FDA training for investigators in clinical research – USA /2013
- Design and Interpretation of Clinical trials - John Hopkins – USA /2014
- Introduction to Pharmacy - Ohio State University – USA / 2014
Career
- PhD in Paediatrics /University of Maastricht / 2004
A PhD research on auxology in 1234 infants
- Research Physician / independent research site PreCare / 1999-2004
Research physician and PI for clinical trials phase II, III and IV
- District Manager / independent research site PreCare / 2000
Research physician, PI, project manager, for clinical trials phase II, III and IV, people management, access to patients, feasibilities
- Medical Director / independent research site PreCare / 2001-2004
Research physician, PI, project manager, budgeting for clinical trials phase II, III and IV, people management, access to patients, feasibilities, educating, protocol developments.
- Senior Consultant at KHG consultancy / 2004 – 2014
All round consulting activities within the pharma/CRO industry, medical setting, teaching at academic and college of higher education (hoge school).
- Founder, owner and director / independent research site PT&R / 2004 – ongoing
Entrepreneur, physician, PI, all round manager
- Founder, owner and director / VivHo – VivMedical-Consulting/ 2013 – ongoing
Medical consultant in the broadest sense
Consulting activities
- Independent physician for clinical trials (The Netherlands)
Acting as an independent physician for various clinical trials conducted at hospitals, research sites and SMOs in The Netherlands in various medical indications for all phases of clinical trials
- Medical translator / Medical reviewer (The Netherlands and Belgium)
Review of trial documents for patients that were going to be used in clinical trials and submitted to IRBs. This included but is not limited to ICF, advertisement, brochures, druglabels, diaries
- Feasibility consultant for Pharma and CROs (The Netherlands and Belgium)
Perform feasibilities for new potential clinical trials describing access to patients, recruitment strategies, site strategies and market access for all phases of clinical trials
- Feasibility manager for large multinational CRO (Belgium).
For 10 years performing all feasibilities, internal and external capabilities and landscape assessments for potential upcoming trials by liaising with physicians including KOLs, mostly phase I, II and III
- Protocol reviewer for Pharma and CROs (The Netherlands and Belgium)
Review of protocols for feasibility, access to patients, determine bottlenecks and challenges, comparing to SOCs, all phases of clinical trials
- Protocol (co)writer for Pharma and CROs (The Netherlands and Belgium)
(Co)developing protocols for clinical trials phase II, III, IV/PostMarkerting
- eDC betatester (Belgium, The Netherlands and USA)
Testing of eDCs from various vendors, for a specific clinical trial from a site’s perspective
- Clinical (trial)portal advisor and betatester (Belgium, The Netherlands and USA)
Testing of Portal that will be implemented in clinical trials for userfriendlyness from a site’s perspective
- ETools advisor and betatester (Belgium, Germany, The Netherlands and USA)
Testing and advising the use and development of etools i.e. eportals, ediary, trialslides, BYOD on userfriendlyness for sites and patients. Developing of a certifications program for sites.
- CRA trainer for Pharma and CROs (Belgium, Germany and The Netherlands)
Developing training material and educating CRAs and other clinical operation staff members on, but not limited to: interpretation of lab results, documentmanagement in clinical research, introduction into clinical research, GCP, SOPs and Quality, How to read a protocol, Etools in clinical research, Budgetting, Feasibilities in clinical research, Site-Sponsor cq PI-CRA relationship and communication.
- University Teacher post doc education on clinical research (UZ Antwerp)
Developing training material and education students on SOPs development and quality in clinical research
- Exam commission eBROK / GCP (The Netherlands)
(Co)-developing new casus and questions for the national exam and assess appeals from exam candidates on exam questions.
- Ambassador for GCPCentral (The Netherlands)
The site’s perspective on GCP training
- Independent consultant for the Non WMO clinical trial evaluation program (The Netherlands)
Acting as an independent consultant for the working group and IRBs in the pilot fase of implement the new guidelines on Non-WMO clinical trials
Memberships
- Register of Clinical Pharmacological research physician / Netherlands
- ACRP & APCR / USA
- NVFG / Netherlands
- SCRS / USA
- ACRON / Netherlands
Executive Functions
- (Medical) Director and owner of the independent research site PT&R
- NVFG: chairperson communication commission, member of the board of the NVFG
- NVFG: member of the Clinical Operations Working group
- NVFG: head -editor of the FIAgnostiek Magazine
- ACRP: member of the Belgium chapter board
- eBROK/GCP: member of the national examination commission
- SCRS: Initiator and leader of the White Paper on Feasibility streamline workgroup
Additional Education, Trainings and Certifications
- English Communication Course for the Medical Faculty/ 1991at World Net
- Summercourse Burns and Children at Beverwijk / 1992
- Einführung in die Klinische Medizin at Aachen / 1993-1994
- Elective Pediatrics at the university of Oxford; Racliff Hospital / 1995
- Elective Genetics at the university of Oxford; Churchill hospital / 1995
- Diploma of the Dutch Foundation for Sportmassage /1995
- 7th HGH Symposium in Madrid / 1996
- Summer-course Physical Anthropology at the university of Leiden /1996 under the auspices of Dr. G.J.R. Maat
- 10th Congress of the European Anthropological Association / 1996 at Bruxelles
- Selection-education laboratory training genetics MCB & Genetics / 1997 / at Maastricht
- Boerhaave-course: TNO/LUMC symposium: The Fourth National / 1998 / Growthstudy
- PhD-research Pediatrics / 1993 – 2004 / A SMILE: Anthroplogical Survey of Maastricht Infants Longitudinaly Evaluated
- Training Quality and Dutch requirements related to Clinical Drug Research / Profess Medical Consultancy BV / 1999 /
- Symposium Law Medical Scientific / research with people (WMO) / 1999
- Inhouse GCP course given by Profess Medical Consultancy BV / 2000 and 2005
- Training Dependency and influence related to clinical drug research/ Profess Medical / / Consultancy BV / 2000
- Evening workconference New Dutch Regulatory Requirements / Profess Medical Consultancy BV / 20001
- Beyond the informed consent / 2001 / Training by Bayer institute for HealthCare Communication
- DEXA training for Hologic QDR 1000 / 2001
- Boerhaave-course: ECG reading and interpretation / 2002
- GCP for site coordinators & CRA's / Training Days - Erik Klaver / 2003
- SOP's in CRO / Q University / 2004 – 2014
- CRA training / Q University / 2003
- Financial management / Q University / 2003
- ECTD / Q University / 2004
- Introduction in Complaints Management / Q University / 2004
- Goal Setting / Q University / 2004
- Problem Solving / Q University / 2004
- Signature irregularities and fraud / Q University / 2004
- GMP / Q University / 2004
- Boerhaave-course: Stralingshygiene 4A/M (radiation hygiene) / 2005
- DEXA training for Hologic QDR 4500 / 2005
- Lab in clinical trials / 2005 / certificate and trainer
- GCP training at all investigators meetings / 1999-2014
- GCP Q University / 2008-2014
- GCP etraining NovoNordisk / 2008-2011
- IATA / 2012
- Various GCP trainings / exams (at least once a year) / 2000-2014
- Barnet GCP exam / 2013
- Barnet GCP exam for CROs / 2013
- Barnet GCP exam for CROs / 2014
- ECG reading and interpretations / 2014
- Pulmonology tests and interpretations / 2014
Presentations and publications
- Symposium on Problems and Solutions in Longitudinal Research 31/08/96 - 02/09/96 - Preliminary finding on the longitudinal growth research of Maastricht
- Auxology and Nutrition Today - 15/10/1996 - Dutch longitudinal growth study
- International Journal of Sports Medicine- suppl 3; vol 18; july 1997; pg S247- The Maastricht longitudinal growth study
- Partial circumcision in children, 14 years’ experience(abstract) - 5th int congress of the DUA 2-4 sept 1999
- Partial circumcision in children (poster) - 5th int congress of the DUA 2-4 sept 1999
- Analysis of growth data – 2007
- Patient retention in longitudinal clinical trials - Athens Smart meeting 13/04/02
- CRO-SMO: Partners in Business or Business Partners - The Monitor, Spring 2002 vol 16 pg25-28
- SMO in Paediatric trials - GCPj autumn 2003
- Peaditric trial development in the European Union – FIAgnostiek
- Various advertorials – FIAgnostiek - 2006-2014
- A Smile presented at Auxology Symposium: Growth in Sickniss and in Health – Florence -2006
- Lab interpretations in clinical trials, CRA training - CRO's & Pharmacompanies/ 2006-2010
- CRA vs Investigators, pharma training - CRO's & Pharmacompanies / 2005-2010
- Documents in clinical trials, CRA training- CRO's & Pharmacompanies / 2006-2011
- Protocol interpretation – CRO's & Pharmacompanies /2006-2010
- Feasibility, training for senior CRA's - CRO's & Pharmacompanies / 2006-2011
- SMV reporting: best practices workshop - Quintiles Belgium – 2011
- Is Rosi toch Rooskleurig – Diabetologie - dec 2009 jaargang 7
- Social Media and Clinical Research/ Pharma – FIGON - okt-10
- Social Media and Clinical Research/ Pharma - CRA national symposium - mei-11
- Social Media and Clinical Research/ Pharma - ACRP Belgium - jun-11
- Social Media and Patient Recruitment - Science Alliance jun-11
- Social Media & Clinical Research - ACRP Belgium - okt-11
- Creative patient recruitment - ACRP USA Houston - apr-12
- Social Media in Clinial Trials - CTCM congress - apr-13
- Recruitment and Social Media - ACRON congress - jun-13
- Access to Patients or Patients with access - BECRO congres Belgium - oct 2013
- Access to Patients or Patients with access - Sanofi Aventis convention NL - sep-13
- Edairy, eportal, epatient, edoctor: evolution? - E- Pro convention Barcelona - jun-14
- Recruitment and Social Media - Wetenschapssymposium Orbis/ Atrium MC – jun-14
- Edairy, eportal, epatient, edoctor: evolution? / pitch - ACRP congres Belgium- oct 2014
- Edairy, eportal, epatient, edoctor: evolution? - Grunenthal -Aachen – Clinops - oct-2014
Research and Trial experience as physician / PI
- L' Aemi; anthropometry in infants / 1993-2004
- Anthropometry of children and adolescents AZM / 1995-1999
- Anticonception / 1998-2013
- Circumcision / 1998, 1999
- Hypercholesterolemia / 1999-2013
- Psoriasis/ 1999-2014
- Hypertension /1999-2014
- HRT / 1999-2007
- Osteoporoses / 199-2014
- Influenza / 1999-2010
- Rhino Pharyngitis & Sinusitis / 2000-2003 &2009 -2010
- Acne / 2000-2003
- DM type II / 2000-2014
- Osteoarthritis /2001-2009
- PMDD / 2001, 2002
- IBS / 2001-2009, 2013-2014
- Alopecia / 2002
- Rheuma / 2002, 2003
- FSAD / 2002, 2007
- DM type II in adolescent / 2003
- PE / 2005
- Endocrinology / 1999-2014
- BPH / 2006, 2007, 2013-2014
- Hypogonadism / 2006
- DUB / 2006-2009, 2013
- Cardiovasculair (non interventional)/ 2003-2014
- Vaccination / 2007-2009
- Allergies / 2007-2011, 2014
- Obesity / 2007-2014
- Infectious diseases (including vaccinations) / 2004-2010
- COPD / 2008-2014
- Asthma / 2011-2013
- Dyspepsia / 2012-2014
- Obstipation / 2012-2013
- Dermatitis / 2007-2012
- Neuropathy / 2013-2014
- Fibromyalgia / 2014
Links
www.ptr.nu
www.dexa.nl
Services provided
- clinical trial consultancy
- protocol review
- independent physician
- trial specific recruitment strategy
- patient recruitment
- patient screening
- perform feasibilities
- provide training
- site coherence check
- trial implementation for sites
- etools in clinical trials
- social medai in clinical trials