Welcome to my website. Here, my services are listed and further clarified.

Let me assist you and your team with your clinical trial operations / QA affairs, monitoring and data management activities.

Explore this site to find out why.

My Services

Offered to Pharma, Biotech, CRO, Institutions, Consortia, and Investigators

Basic Service

In line with ICH GCP E6 R3 guideline (section herein):

  • 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 (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 of the various DATs in use

  • Audit trail review, same

  • 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.

From my office, located in the city of Almere, The Netherlands. With a set of lean SOPs for quality business operations

~ ICH E8 R1, ICH Q9, (OECD) GcLP, (SCDM) GCDMP, EudraLex Vol 4 GMP, 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

  • Interactions with European Medicines Agency (EMA), as an SME (reg #EMA/SME/C/114/23)

Advanced Service

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 is 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.

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)