31st May 2021

Newsletter May 2021

CVBF CRO Services designed for
your Clinical Trial!

CVBF is a self-certified Contract Research Organisation (CRO) at the Italian Medicines Agency (AIFA) and performs clinical research since 2002.
CVBF offers a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies, as well as academia, to bring new drugs and devices to the market and allow patients access. The CVBF CRO SERVICES span the entire lifecycle of product development and can be tailored from phase 1 trials at a single site to large multinational projects.
CVBF CRO professionals are experts in successfully planning and delivering clinical research. CVBF CRO values its client’s time, cost, and quality to guarantee that these metrics are met.
Read more about the available CVBF CRO SERVICES and get in touch with us, we will help and guide you through out the entire process.

DEEP-2 Study results published on EU and US CTs registries

The results of the DEEP-2 paediatric clinical trial are NOW AVAILABEL on ClinicalTrials.org as well as on the EU Clinical Trials Register. Click on the image and listen what the DEEP-2 Trial Leader, and CVBF CEO, Donato Bonifazi said.

The “Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project” article has been recently published on BMC Medical Ethics. It was written by the DEEP-2 Study trial leaders and Ethics board members. Main results shown that authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. Factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries.

Highlights From the Pharmacovigilance Risk Assessment Committee (PRAC)

EMA’s safety committee – PRAC has recently met to discuss about all aspects of risk management associated with medicine use. Moreover, PRAC has also finalized its review on COVID-19 Vaccine Janssen and confirmed, as previously communicated, that its benefits outweigh the risks of side effects. PRAC continues to closely review Comirnaty product’s information and COVID-19 Vaccine Moderna for unusual blood clots with low blood platelets.

EndeavorRx™
The first-and-only FDA-cleared treatment delivered through a video game experience

It is time to change the way medicine is designed, delivered, and experienced. The NEW EndeavorRx app is an innovative digital treatment indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type Attention Deficit Hyperactivity Disorder (ADHD) who have a demonstrated attention issue; its use should be considered as part of a therapeutic program.

EJP RD launched its first massive open online course – MOOC

The EJP RD has launched its first academic education course “Diagnosing Rare Diseases: from the Clinic to Research and back” related to diagnosis in the rare disease’s context. The course started on April 26th and will last 5 weeks with 3 hours weekly study; it targets professionals with a keen interest in diagnostic research and rare diseases.

This incredible Summit is designed to support pediatric youth voices around the world by spotlighting the needs that matter most to kids. This is a fun and exciting week-long, daily event created for iCAN youth members, community leaders, and healthcare professionals to learn and share expert global pediatric patient insight, further improve healthcare innovation, and participate in quality and research improvements throughout medicine.

Registration is free, click here to join it!