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T E S T I M O N I A L S
Dayana Michel, M.D., Vice President Medical @ Kamari Pharma | Clinical Development Expert, Israel
"I highly recommend Naida as an exceptional medical writer. With extensive experience, she brings deep scientific expertise and outstanding writing skills to every project. Naida has long clinical research experience and is highly organized, detail-oriented, and an excellent collaborator, making her an invaluable asset to any team."
Chen Binyamin, Head of Clinical Services at Bioforum Clinical Services, Israel
"I have had the privilege of knowing Naida for over a decade, and during this time, she has consistently demonstrated outstanding expertise in clinical writing. Her deep knowledge and precision in developing Clinical Protocols, Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), and Clinical Study Reports (CSR) make her an invaluable asset to any organization."
Nissim Shaked, QA/RA Specialist, Israel
"Naida is a truly exceptional professional who has a gifted personality. Naida was leading some of clinical research and investigation in 2 companies in which I was also involved, Naida has the talent to lead through all aspects of Clinical Research according to the MDR and US clinical regulations, Naida's vast knowledge and communication skills are extraordinary. She is a hard worker who sees the whole picture while not ignoring the details. I will be happy to provide you with any further information on Naida."
L A T E S T A R T I C L E S
A R T I C L E S
The Medical Device Regulation (MDR) introduced by the European Union (EU) requires robust clinical evaluation to ensure the safety and performance of medical devices before they are marketed. What is Clinical Evaluation?
First-in-man (FIM) studies are critical in evaluating the safety and efficacy of new drugs or medical devices in humans for the first time. While they are a necessary step in the development process, these studies come with unique challenges.
Good Clinical Practice (GCP) audits are essential for ensuring that clinical trials are conducted in compliance with regulatory standards, protecting patient rights, and ensuring data integrity.
