Welcome to my website. On it, my services are listed and clarified.
Let me assist you and your team with your clinical trial operations / QA-, GDPR-, and Pharmacovigilance affairs, monitoring (of any kind) and data management activities.
Explore this site to find out why.
My Services
Offered to Pharma, Biotech, CRO, Institutions, Consortia, and Investigators
From my office, located in the city of Almere, The Netherlands. With a set of lean SOPs for quality business operations
Basic Service
In line with ICH GCP E6 R3 guideline (section herein), the EU Clinical Trials Regulation (EU) Nr. 536/2014, other country-specific guidances, as applicable
Investigator Site Selection (3.7)
Communication with Ethics Committee / RA (3.8)
Apply for EC and RA approvals, via CTIS in EU
Sponsor Oversight tasks/duty (3.9)
Monitoring (3.11.4) all aspects, including:
investigator site monitoring
centralised monitoring
issue a risk-based Monitoring Plan
follow-up on noncompliance (3.12); root cause analysis, CAPA implementation
The basis for me: Keep investigator sites involved, motivated and informed, so capable of collecting high-quality clinical data in time and on the budget. Build and extend relationships with other Service Providers. Lean reporting to my client, escalating issues if needed.
Intermediate Service
In line with ICH GCP E6 R3 guideline (section herein):
Quality Management (3.10), using critical to quality factors
Risk Management (ICH Q9 R1 as well)
Sponsor Oversight task; Service Provider Management
(co-)Build Data Acquisition Tools (DATs)
DAT validation, fit-for-purpose testing
Central review and audit trail review of the various DATs in use
(e)TMF / Essential records; build, Quality Control, keep-up
In this area, I am your (additional) Project Manager, building report, communicating, organising, keeping an eye on potential risks, applying Plan-Do-Check-Act.
Advanced Service
~ ICH E8 R1, ICH Q9, (OECD) GcLP, (SCDM) GCDMP, EudraLex Vol 4 GMP, GDPR, GVP, and ISO 9001:2015
Data Analysis (using RStudio, MS-Excel)
Quality Management System; build, maintain
Build Quality into your trial, into the manuals, the DATs (Implement Quality-by-Design, or QbD)
Quality Assurance (QA); e.g. qualify Service Providers, internal auditing
Quality Control; oversight role, targeted auditing
Risk Based strategies development
Assist with data base cleaning, reconsile / merge databases
Operate as your Data Protection Officer (following GDPR)
Be your company’s Responsible Person (RP) for EudraVigilance (my entity is ORG-100047191)
Interactions with European Medicines Agency (EMA), I can do for you, being an SME (reg #EMA/SME/C/114/23)
Over the last two decades, the clients I served have appreciated my added value to their clinical trials operations.
Approx. 70% of my current business consists of repeat business.
To keep myself trained, and aware of new developments, and to network, I am a member of a few organisations, here below I list a few.
I operate my own QMS, which consists of a few SOPs. The latest I added covers the use of generative AI in the work I offer to my clients.
Association of Clinical Research Professionals (ACRP)
The Research Quality Association (RQA)
Dutch Association of Research Quality Assurance (DARQA)
European Forum for Good Clinical Practice (EFGCP)
Indicro. A new platform I am excited about.
