Clinical Trials: Monitors and Research Coordinators

Improving Efficiencies in Data Collection: Electronic Source

Introduction to Source Documentation Source documentation is the initial documentation of clinical trial data, regardless of format...

Good Documentation Practices for a Clinical Trial

Source documents are essential documents that are required for Good Clinical Practice. It is the first place...

How to Start a Clinical Trial: 10 Steps to Meet FDA Standards

Starting a clinical trial is a critical milestone in bringing new medical products to market. Whether you...

Rethinking Representation in Clinical Research – Who’s in the Study?

Introduction The underlying principle of a clinical study is to assess the safety and efficacy of an...

Patient-Reported Outcome (PRO)

“What matters is this – will it help patients?” ~ Bill Cook Introduction To ensure that patients...

The Impact of GCP R3 on Your Trial Master File

Introduction The third revision (R3) of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) was...

5 Main Components of a MDR Clinical Evaluation Report (CER)

To comply with the European Union Medical Device Regulation (MDR), medical device manufacturers are required to conduct...

Deviations in Medical Device Clinical Studies

Introduction During the conduct of a study, there may be instances where the study protocol is not...

Strategizing Biocompatibility Evaluation in Changing Manufacturing Environments: When do you Approach Subject Matter Experts?

In a dynamic manufacturing environment, changes are inevitable. Ensuring medical device safety is very crucial, particularly when...

Developing a Quality System / Standard Operating Procedures for Conducting Medical Device Clinical Trials

Introduction The development of quality system procedures or standard operating procedures (SOPs) for conducting clinical trials of...

Surface Morphology: A Case Study On Implantation Endpoint

In a previous blog post, we highlighted the essential role of surface characterization in ensuring the biocompatibility...