Who is this blogger?
Annet Visscher
My name is Annet Visscher and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
- +31 26 800 1219Standard time zone:
UTC/GMT +1 hour -
-
Recent Posts
Latest Tweets
Tweets by AnnetMuetstegeMost used tags
- Adverse Event handling
- Clinical benefit
- clinical evaluation
- Clinical Evidence
- Clinical Evidence Plan
- Clinical Investigation
- Clinical Research
- clinical studies
- Clinical Study Population
- Clinical Trial
- Clinical Trial Investment
- clinicaltrials gov
- Controlled Clinical Trial
- Coronavirus
- Cost Effective
- Country Regulations
- COVID-19
- daily practice
- Data protection
- Data Transparency
- Declaration of Helsinki
- effectiveness
- Efficacy
- Ethics Committee
- EUDAMED
- Europe
- GCP
- GDPR
- Guidelines
- Health Care Market
- Health Economic Model
- Health Economic Outcomes
- Health Technology Assessment
- IIT
- Informed Consent
- informed consent process
- investigator-sponsor
- ISO 14155
- ISO14155
- IVDR
- Market adoption
- MDCG guidances
- MDD
- MDR
- MEDDEV 2.7/1
- MEDDEV 2.12-2
- Medical Device Directive
- Medical Device Regulation
- Medical Devices
- Monitoring
- NICE
- Patient Outcomes
- Patient Safety
- performance evaluation
- PMCF
- post-market clinical follow-up
- Post-market Observational Study
- Postmarket Clinical Follow-Up
- Postmarket Safet Reporting
- Postmarket Safety Reporting
- Postmarket Studies
- Postmarket Surveillance
- Premarket Safety Reporting
- Premarket Study
- Product Claims
- Publication
- Publication Bias
- Publication Strategy
- Registry
- Reimbursement
- remote monitoring
- risk-based monitoring
- Site Monitoring
- Sponsor
- Vigilance
Tag Archives: Efficacy
WHAT CLINICAL BENEFIT DO YOU WANT TO PROVE IN YOUR STUDY?
Defining the clinical benefit or the efficacy parameters for your product in a clinical study is a challenging but critical activity: Do I aim to show the effect of product itself or that of a treatment as a whole, what … Continue reading
CLINICAL EVIDENCE DILEMMAS: IS MY CLINICAL STUDY POPULATION THE RIGHT ONE?
Is my study population the right one, or in other words: Does my clinical study population represent the patients the study product is meant for? An essential question to answer when designing a clinical study to collect clinical evidence regarding product … Continue reading
CLINICAL EVIDENCE DILEMMAS: CONTROLLED CLINICAL TRIAL OR DAILY PRACTICE?
Designing a clinical study, often faces discussions that can be traced back to the type of clinical evidence one is looking for: Are you aiming to evaluate the product effect in a controlled clinical study environment, or in a real … Continue reading
Posted in Uncategorized
Tagged Clinical Evidence, Controlled Clinical Trial, daily practice, effectiveness, Efficacy, Premarket Study
4 Comments
EUROPEAN MEDICAL DEVICE REGULATION – FIVE KEY DRIVERS OF THE PREMARKET CLINICAL EVIDENCE BASE
The Medical Device sector concerns a wide variety of products and the proposed European Medical Device Regulation attempts to regulate the pre- and postmarket clinical evidence base under one umbrella. Driven by scandals such as with the hip and PIP … Continue reading
Medical Devices Clinical 