The People-Centric Approach is the pillar through which Evidilya is continuously accelerating Health innovation: we drive studies according to our PHYGITAL-CROWD enrolment strategies, Participants and Study Stakeholders Virtual management Platforms and Direct to Participant Concierge Support Programme.

Finally, in Europe a 100% virtual research and People-Generated Data that will allow us to study the relationship between vaccination against Covid-19 and health at 360°, as regards nutrition and lifestyles.

Evidilya, the Evidence Generation CRO acting worldwide in the Pharmaceutical and CHC field, has been awarded with the Crédit d'Impôt Recherche (CIR) from the French ministère de l'Enseignement supérieur

The U.S Food and Drug Administration has released its standards on how it will proceed to analyze experimental vaccines against the SARS-CoV-2.

With the aim of accelerating COVID-19 clinical research in resource-limited settings, a Global Coalition was established, based on multinational and multidisciplinary expertise and clinical trial capacity.

The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences R&D, has recently released the latest Unified Data Model (UDM) file format, Version 6. The aim of the UDM project is to create and publish an open and freely available data format for the storage and exchange of experimental information regarding compound synthesis and testing.

The Italian Medicines Agency (AIFA) has recently provided some guidelines regarding the management of clinical trials in Italy that will be valid until further notice.

We are pleased to announce that Evidilya has participated as CRO in a multinational study aimed at evaluating the psychometric properties of the RAPP.

Rare disease day was celebrated on the rarest day in the year: February 29th, 2020. There are 7000 known rare diseases, defined as diseases that affect fewer than 200,000 people in the USA. For rare diseases, the challenge is that it is often not feasible to conduct traditional randomized phase III clinical trials.

The University of Nebraska Medical Center (UNMC) has started a randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with COVID-19.

This is the main topic addressed by FDA Commissioner Stephen Hahn during an all-hands first meeting with FDA staffers.

This is what has emerged from a new study, published in the Journal of the American Medical Association: real-world data sources available nowadays could only replace 15% of the clinical trials that have been considered in research. 

The pivotal US Clinical Trial (IMPLANT 3) will evaluate Nolasiban’s efficacy in women undergoing embryo transfer (ET) following in-vitro fertilization (IVF)

Get ready for the next level of Evidence Generation.

An observational retrospective study has evaluated the combination of tafasitamab (MOR208) with lenalidomide (Revlimid) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who were not eligible for high-dose chemotherapy and stem cell transplant.

Although“… there has been awareness regarding disparity”, as explained by Dr. Jonathan Loree, the lack of ethnic diversity in clinical trials for cancer drugs should be considered more thoroughly by the scientific community.

Due to the enormous knowledge and expertise gained in the analysis and usage of big data driving digital innovation, it appears that the tech giants will be making a crucial impact in this sector.

Considering the growing interest supported by the improvement of technologies in this sector, the agency is currently investigating when the use of observational data “may be appropriate for evaluating effectiveness from a broad policy perspective and also how individual drug manufacturers submit proposals for using real world data to support marketing applications”.

A Phase I/Phase II Clinical Trial is ongoing to test the Italian version Car-T therapy, called Carcik, aimed at treating LLA – Acute Lymphoblastic Leukemia - at the San Gerardo Hospital in Monza and at the Papa Giovanni XIII Hospital in Bergamo.

The first Clinical Trial will be starting to test the gene-editing technique CRISPR in the United States this Fall.

Until now, companies have considered RWE studies useful mostly for post-approval safety; there are some big opportunities on the Real-World Evidence horizon that industry and regulators will be considering and implementing soon.

A new deep learning model, developed by a team from MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) and Massachusetts General Hospital (MGH), is attempting to detect patients at risk of breast cancer at an early stage, before the development of the disease, avoiding later diagnosis.

A review recently published in the Journal Trends in Pharmacological Sciences analyzed the potential improvements that AI could bring to drug development in the next decade

Evidilya has partnered market leaders and technology innovators in the life sciences sector worldwide. Thanks to strategic operation hubs around the world and partnerships with a global network of science specialists, we are able to implement both international and country-specific research projects.

Launched by Fitbit, Bring Your Own Device is the first digital health technology initiative. It is part of the National Institutes of Health’s All of Us research program and it is developed under the Precision Medicine Initiative. It consists in a fitness tracker that has the goal to collect data from a variety of populations drawing on surveys, physical measurements, EHRs, and digital health technologies.

The days when mobile phones were “simply” a tool used to connect people distant in space, seem so far away. A novelty that eradicates once again this definition, now outdated, is launched by a startup from Palo Alto, California.

Following a request by EFSA, the Panel on Nutrition, Novel Foods and Food Allergens has recently updated the scientific requirements for health claims related to muscle function and physical performance, originally published in 2012.

It’s been 60 years since the first implantable pacemaker was introduced into the market. Today a new monitoring process is available for patients and Hp’s: Medtronic – whose founder created some of the first pacemaker models – has designed a mobile app that enables pacemakers-communication via mobile phone or tablets.

FDA has recently taken action in the real-world evidence field by releasing a new health App: MyStudies App is a standardized digital platform where researchers can collect, organize and analyze a variety of data directly from the real-world environment.