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VivHo is a life science consultancy company owned by Vivienne van de Walle MD PhD aiming to share her many years of experience in clinical research.

Although society emphasises pharmaceutical companies to focus on the public cause, the return on investment will play a key role in future development of medicine. Together with a national and international network and a broad experience on different indications VivHo is capable to give you a guaranteed added value. In comparison with others VivHo profoundly think that the added value is to diminish uncertainty and creativity. The growing belief in this approach results in an output that benefits patients and CROs and Pharma-companies.

On many levels within a chosen project structure there is the need for a continuous exchange of information. Managing this interface demands an effort of all parties involved. VivHo is looking forward to working with you in a close collaboration to achieve our common goal: researching future medicine and getting the best treatment options available quickly to those who need them.

About

Vivienne van de Walle studied medicine at the University of Maastricht in the Netherlands and did part of her medical training at the University of Oxford in the UK. During her medical training she enjoyed the combination of patient care and clinical research. She received an additional medical science degree for her research when she graduated. In 2004 she successfully defended her thesis for her PhD. In 2011, she passed the CPI exam. She has always combined clinical research with patient care and has been a full time investigator since 1999 at independent clinical research sites. She is a registered physician in both The Netherlands and Belgium and is an active member of various professional associations in which she acts in various boards. She has a special interest in implementing etools in the medical field in general and clinical research specifically.

Her experience is reflected by her skills in consulting, education, management, leadership and executive functions. She keeps developing procedures in various directions by means of streamlining workprocesses, integrated care, improving quality systems, translating and implementing protocols to the workplace in the medical field in general and clinical research specifically.

With her PT&R-team she was also the proud winner of the inaugural SPRIA EU award of the SCRS . In 2019 she was nominated for the Clinical Trial Europe – Christine Pierre Life Time Achievement Award and in 2020 she was nominated at the 5th World Congress on Advanced Clinical Trials and Clinical Research for Women in Science Awards / Women Scientist. She started her research career as a participant in a clinical trial. As a result, Viviënne has a unique perspective of the various sides of the table in clinical research and is eager to share her many years of experience. As she states: “I love it when you pick my brain”.

Contact

Please feel free to contact us to discuss my input regarding

  • clinical trial consultancy
  • protocol review
  • independent physician
  • trial specific recruitment strategy
  • patient screening
  • perform feasibilities
  • provide training
  • site coherence check
  • trial implementation for sites
  • etools in clinical trials
  • social media in clinical trials
  • site payments

VivHo
Grote Dries 6
6123BV Holtum
The Netherlands
tel: +31 628878646
email: info@vivho.com

CV

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 Universityof 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 (ACRP) – USA / 2011/2013/2015/2017/2019
  • ACRP-PM – USA / 2019
  • FDA training for investigators in clinical research – USA /2013
  • Design and Interpretation of Clinical trials – Johns Hopkins/Coursera – USA /2014
  • Introduction to Pharmacy – Ohio State University/Coursera – USA / 2014
  • FAPCR – USA / 2016/2018/2020

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 / since 2004
    Entrepreneur, physician, PI, all round manager
  • Founder, owner and director / VivHo – VivMedical-Consulting/ since 2013
  • Medical consultant in Life Sciences for a.o. Quintiles, MSource, Astellas, Nutricia, Nubellum Research.

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 Quintiles NV, alarge 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 beta-tester (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 userfriendliness from a site’s perspective
  • eTools / ePRO advisor and beta-tester (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 educating 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
  • Within the SCRS participating in various SAG for CRO’s, vendors and TransCelerate
  • Senior Dara Assurance and Medical Consistency Manager PV – Astellas (The Netherlands)
  • Director of Education – SCRS (USA)
  • Medical Monitor – Danone (The Netherlands)
  • CMO – Nubellum Research (USA)

Memberships

  • Register of Clinical Pharmacological research physician / Netherlands
  • ACRP / USA
  • 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,
  • NVFG: vice-president of the board of the NVFG
  • NVFG: member of the Clinical Operations Working group
  • eBROK/GCP: member of the national examination commission
  • SCRS: Initiator and leader of the White Paper on Feasibility Streamlining
  • SCRS: Member of the Leadership Council
  • SCRS: Site Solutions Summit advisory board (both USA and EU)
  • SCRS: President EU Site Solution Summit

Research & Trial experience as PI / physician 

  • L’ Aemi; anthropometry in infants / 1993-2004
  • Acne / 2000 – 2003
  • Allergies / 2007-2011, 2017 – 2020
  • Alopecia / 2002
  • Alzheimers Disease / 2019 – 2020
  • Anthropometry of children and adolescents AZM / 1995-1999
  • Anticonception / 1998-2016
  • Arthritis / 2019 – 2020
  • Asthma / 2011 – 2018
  • BPH / 2006, 2007, 2013 – 2014
  • Cardiovasculair (non interventional)/ 2003 – 2020
  • Circumcision / 1998, 1999
  • COPD / 2008 – 2019
  • COVID-19 & Corona / 2020
  • Dermatitis / 2007 – 2019
  • DM type II / 2000 – 2014
  • DM type II in adolescent / 2003
  • DUB / 2006-2009, 2013
  • Dyspepsia / 2012 – 2014
  • Endocrinology / 1999 – 2019
  • Fibromyalgia / 2014 – 2016
  • FSAD / 2002, 2007
  • Hypercholesterolemia / 1999 – 2020
  • IBS / 2001-2009, 2013 – 2014
  • Infectious diseases (including vaccinations) / 2004 – 2010
  • Influenza / 1999 – 2010
  • Hypertension /1999 – 2014
  • Hypogonadism / 2006
  • HRT / 1999 – 2007
  • Neuropathy / 2013 – 2014
  • Obesity / 2007 – 2014
  • Obstipation / 2012 – 2013
  • Osteoarthritis /2001 – 2009
  • Osteoporoses / 1999 – 2019
  • PE / 2005
  • PMDD / 2001, 2002
  • Psoriasis/ 1999 – 2020
  • Rheuma / 2002, 2003
  • Rhino Pharyngitis & Sinusitis / 2000 – 2003 & 2009 – 2010
  • Vaccination / 2007 – 2009

Additional Education, Trainings & Certifications

  • English Communication Course for the Medical Faculty / 1991
  • 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 / 2001
  • 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 / 2019
  • 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
  • Update GCP / WMO / 2017
  • GCP 2019
  • Comfort Talk / VHYP.be 2019 – 2020
  • GCP / ACRP 2020

Publications & Presentations

on request (info@vivho.com)