ISO 13485 – Change? Do I Have To??
This white paper reviews the conundrum companies are experiencing if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements...
Clinical Management Toolkit from MasterControl
Effective management of a clinical study must incorporate not only all the activities and records that comprise a study, but the capacity to efficiently and rapidly assess...
Eliminate TMF Inadequacies in Your Clinical Trials
To comply with regulatory requirements pertinent to clinical trials, every organization engaged in a clinical trial must manage and maintain all trial-related content, documents,...
Top 8 Obstacles in Pharma & Biologics Product Registration & Submission Management
For pharmaceutical and biologics companies, the path to a global product launch is full of obstacles that could result in delays to registrations, many of which can be avoided...
Top 5 Trends in the Pharmaceutical Industry in 2018
This white paper takes an in depth look at trends in the pharmaceutical industry that are anticipated to make a significant impact on the sector in 2018. Industry professionals...
How to Address 10 Common Pains in Dossier Management & Product Registration
While the process for obtaining a device clearance or premarket approval (PMA) in the United States is not the same as applying for a Shonin in Japan or a CE mark in Europe,...
Top 5 Medical Device Industry Trends in 2018
Digital device technology continues to move at a fast pace, which means device manufacturers should keep a close watch on emerging trends and be ready to adapt to new ideas...
How Healthcare Benefits from Cloud-Delivered Security
Healthcare IT professionals are swimming upstream to overcome security challenges. Cloud-delivered solutions may represent a life preserver in their efforts to reduce risk,...
How Global Pharmaceutical Leader Lundbeck Boosted Security and Efficiency through Cloud Security.
“We liked that Umbrella’s intelligent proxy would give us granular protection without the performance impact of a traditional web proxy.” – Torben Olsen, Corporate...
Digital Transformation: Why Healthcare Companies Are Adopting A Suite Approach to Software
The healthcare industry faces constant regulatory change, escalating pressure to control costs and an increasingly complex competitive landscape. To stay head of the curve,...