Previous Projects

The past 21 years that I have worked as an independent contractor have been excellent. I took on quite a few roles (such as the regular Site Monitor/CRA performing remote and on-site monitoring visits, but also that of Project Manager, Data Manager, QA Manager, Data Analyst), depending on the client’s needs /wishes.

Regarding my business operations, here below I share with you some significant facts:

  • the projects were mainly in the field of orphan diseases, in phases I – II, usually with adaptive trial protocols. This can be seen as my ‘niche’ area indeed
  • approx. 60 % of the current assignments are in the ‘repeat business’ category, one way or the other
  • apart from the Netherlands, the assignments have taken me to the United Kingdom, Germany, Belgium, France, Portugal, Denmark, and Sweden.
  • I am able to manage 3-4 active clients or trials/protocols at any given time. Switching between these has shown to be efficient for both my clients and myself, and keeps me alert. This I actually consider a business asset.
  • clients based in the US can benefit from the fact that I can usually put in work during my evenings; this always turns out good.
  • building a good rapport with trial sites (and at the sites, with the various departments) – in my opinion – actually starts from the first moment of contact, such as during a site evaluation visit. At that time, it is beneficial if all parties share at least some of their expectations.
  • business-wise approaches work best; focus on critical elements in each project/trial (proportionately), whilst ensuring others in the team ‘own’ one or a few elements of the trial process too. Next, proceed whilst staying tuned to these critical elements, improve/develop the elements that can perform better, and follow through. Use timely and concise reporting to the relevant trial stakeholders and manage the work based on the Quality Management System. I tend not to procrastinate.

To make my previous experiences more tangible, here below I share with you a table of test compounds (not all of them, as for some, I am bound by stricter Confidentiality Agreements), I played at least some role in developing:

Generic Name Specialty Name Indication
agalsidase-beta Fabrazyme M. Fabry
alglucosidase alfa Myozyme M. Pompe
alpha-iduronidase Aldurazyme M. Scheie / Hurler
anti-CCR4 antibody NA PTCL
carfilzomib NA various types of cancer
daclizumab Zenapax MS
desmopressin Minirin bedwetting (children)
dipyridamole/ASA Asasantin stroke prevention
enoxaparin sodium Lovenox / Clexane AMI
food product NA Alzheimer’s Disease
idursulfase Elaprase M. Hunter
LAS-34273 NA COPD
latrepirdine Dimebon M. Alzheimer
mesalazine Pentasa Colitis Ulcerosa
placebo placebo various
pridopidine Huntexil M. Huntington
rh HNS NA SanFilippo Disease
SIRT1 activators NA Diabetes Mellitus
tiotropiumbromide Spiriva COPD
TNK-tPA Tenecteplase / TNKase AMI
vaccines to HPV NA VIN
vaccines to P53 NA ovarian cancer