By interpreting the MDR, the trend appears to focus attention on clinical, by referring to sufficient clinical evidence of sufficient quality. Personally, I cannot be happier! Clinical is my favorite topic of interest, but let’s be honest clinical decision making can be complex and activities are costly, therefore, the return on investments should prove worthwhile. You, as a manufacturer, wants to feel secure in providing an amount and quality of clinical evidence that guarantees scientific validity. In other words, safety and/or performance information that is generated from the clinical use of a device collected in a scientifically sound, qualitative way.
On the 12th of June, I had the honor, together with my colleague Wiebe Postma, to train a group of enthusiastic attendees of our ISO14155 GCP training. The trainees came from very diverse backgrounds including pharma industry, medical device manufacturers of all kinds, and academics. The level of experience, and types of questions asked were just as diverse. This resulted in input from various perspectives, interesting example situations and fruitful discussions. Questions included the value and acceptability of investigator-initiated studies (IIS), minimum conditions for site to select them, differences in GCP implementation between pre-CE and post market studies, and many more.
Good Clinical Practice (GCP) is a way of working that safeguards quality. By getting aware of the content of the ISO14155 standard and by implementing it most practically, the ethical aspects, scientific conduct and credibility of your clinical study output are not up for discussion.
During the set-up and execution of clinical trials there are common difficulties you can get across.
In our GCP training, we take the time to discuss possible solutions and common pitfalls, for example:
- Struggles of formulating endpoints
- Ethical considerations
- Statistical considerations
- Which sites to select? How do you qualify them?
- How to avoid a very slow approval process?
- How to accelerate enrollment?
- Monitoring approaches, from 100% SDV to risk based
- What are the pros and cons of paper CRFs versus an EDC system?
- How to implement ISO14155 in post market clinical follow up?
Good Clinical Practice requires practicing. The standard is theoretical but by using it, training on it and finding compliant solutions when you run into complex issues, GCP becomes as standard way of working and decision making.
Trainee testimonial, attending the training on the 12th of June:
“Good, knowledgeable and experienced speakers being able to come up with good examples from the daily practice”.
Are you interested in attending our ISO14155 training? On the 18th and 19th of February 2019 you are very welcome in Amsterdam for a 2-day training.
Do you want to be trained on shorter notice? Or do you prefer an in-house training for your team? Contact us to discuss the options.
Loes Pelgrim