Verona, Italy (30 January 2019) – PM Holding, a group of diverse service providers in the life sciences industry, announces the appointment of Jan Back as Marketing Director to manage marketing across the entire group. PM Holding consists of specialized service providers in the drug and device development sector including: CROS NT (global, expert biometrics…

Post-authorization studies (PAS): European & American approach Randomized trials are the gold standard in evaluating the efficacy of new healthcare interventions. However, despite their ability to potentially provide causal estimates of the efficacy of new treatments, their general nature in relation to patients in the real world is often unclear. Strict exclusion criteria may lead…

The Regulation (EU) 2017/745 (also known as MDR) transition time of three years is about to end – by May 26th 2020 manufacturers of currently approved medical devices need to meet the requirements of the regulation. However, a lot of questions on the compliance procedures have emerged during this transition period. In order to support…

On the 10th of October the top industry professionals gathered in Madrid, Spain, for Regulatory Day, an immersive workshop organized by seQure in collaboration with other PM Holding companies and its partners Oracle Health Sciences and Asphalion. The event, entitled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” brought together the…

Verona, Italy (11 September 2019) – PM Holding, a group of diverse service providers in the life sciences industry, announces the appointment of Angela Weston as Chief Commercial Officer to manage business development operations across the entire group. PM Holding consists of specialized service providers in the drug and device development sector including: CROS NT…

Event titled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” will take place in Madrid on 10th October The PM Holding group of companies including CROS NT, Arithmos, and seQure are excited to announce a Regulatory Day workshop, a unique event in collaboration with Oracle and Asphalion that focuses on the…

What is GCP GCP stands for Good Clinical Practice, a set of standards for designing, recording and reporting trials that involve the participation of human subjects. Compliance with these standards guarantees that the rights, safety, and wellbeing of trial subjects are protected and that clinical-trial data are credible (1). Regulation VS Directive The European Union…

CROS NT, seQure and Arithmos have become a corporate partner and members of the women’s association Verona, Italy (20 June 2019) – PM Holding, a life sciences holding company comprised of CROS NT, seQure and Arithmos, announced a corporate sponsorship and membership for all three companies with Healthcare Businesswomen’s Association (HBA). HBA is a global…

Pharmacovigilance and Digital Transformation: Growing Role of Technology Digital Transformation and Industry 4.0 – these are the topics regularly featured in titles of Life Sciences events and publications recently. While we talk a lot about technologies that disrupt drug development, clinical trials, and pre-clinical stage processes, it is difficult to come across materials dedicated to…

We always aim at staying in close contact with the industry stakeholders and partners, so this October we traveled to Bologna, Italy for the Meet in Italy for Life Sciences conference, the leading national matchmaking and update event on Life Sciences. The Life Sciences sector in Italy is a crucial growth industry in Italy: the…

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