Welcome to Smeets Independent Consultant

To The Point

The way I work can best be described as straightforward. Usually based on priorities set by the project manager on the team, I take on the tasks at hand. Sometimes the prioritising is left to me (this could occur when operating in different time zones, or when unexpected things happen) in which case I keep other team members informed on the decisions made. Primary endpoints of the trial protocol need to be secured. I have the tendency to follow-through till completion, and not to let go. But I always realise I am part of a team, and I both value and appreciate the team spirit.

Knowledgeable

I entered the field of clinical research in 1997, shortly after the E6 ICH-GCP guidelines became 'commonplace'. Ever since, I have either been trained or trained myself on relevant other (inter)national regulations, 'Best Practices' guidelines, and the like. Being a member of several organisations/institutions, I regularly attend their conferences, read their (e-)magazines, have access to their membership fora, etc. aiming to further my knowledge. I participate in the Continued Professional Development program at the Institute of Clinical Research, and keep up my CCRA certification at the Association of Clinical Research Professionals.

Eye For Detail

Subtle changes to the way a trial protocol is being followed, clinical trial site staff who have misinterpreted an important measurement scale, a central lab that fails to report timely, other service providers that might not take their duties seriously enough? The chances are high that I flag such deviations swiftly, assess for risk category and report to the appropriate contacts at my client. Next we will need to decide what corrective and preventive actions are needed.

About Smeets Independent Consultant

Smeets Independent Consultant – SIC, is the full name of my/Edgar’s company, established in 2003. I partner with (bio)pharmaceutical companies or CROs to consult on and assist with a variety of tasks within the clinical research field. All my activities are performed with efficient reporting to my clients (risk-based, lean), and sustained by appropriate follow-up. You are kindly invited to explore this website, and please DO contact me with any questions, or suggestions.

Services offered

Selecting sites for your research project, preparing each, setting up the logistics, contracts, and applying for regulatory approvals (EC and CA)

Central Monitoring, with on-site visits where needed (in line with Risk-based Monitoring approach) (Quality Control)

Quality Assurance when setting up your research project (issue Monitoring Plan, Data Management Plan, etc.

Data Management activities / (extended) Central Monitoring

Employ ACTRIS (see elsewhere) to manage any issues / potential risks

Train or coach other CRAs/monitors working on the same trial

Oversee Safety Reporting, provide follow-up if needed

Generally speaking, all the tasks described under item 5.18 of the E6 ICH-GCP guideline

In general, when submitting your trial to EudraCT, my name and details will get listed at section G5 of 'Annex 1 Clinical trial Application Form' (G5 sub items 1.9, 1.10, 1.11 and 1.13 answered 'yes').