Traditionally, a trial master file (TMF) has been thought of as a collection of documents to be collated to satisfy the regulatory requirements of a clinical study. While this is still the case, today...
The pharmaceutical industry is undergoing a huge transformation. The traditional ways of clinical research will soon be a thing of the past, with disruptive technologies like machine learning (ML), ar...
The life sciences industry today is undergoing a wave of disruption, with biopharmaceutical companies embracing potential new ways to deliver a value-based model over volume by developing specialty pr...
The journey so far Year 2017 was a learning phase for the Medical Device industry. With the official launch of the European Medical Device Regulations (EU MDR 2017/745) and European In-Vitro Diagnosti...
Although high-profile data breaches grab the headlines, behind the scenes, life sciences is just as information sensitive as any industry. Any pharma company faces a major challenge when it comes to c...
TMF practices have matured considerably, and are now recognized as a critical step in the drug development cycle. However, a number of challenges persist. One key issue facing the entire life sciences...
Pharmaceutical companies are often among the largest and most complicated organizations in the private sector, which are constantly under close scrutiny and subject to complex regulation. Their busine...
It’s no secret that drug and device safety is of the utmost importance in today’s competitive life sciences marketplace, and Pharmacovigilance (PV) is a major component of an effective drug regula...