6 Ways Data Science Can Improve Your Life Sciences Operations
The proper use of data science and predictive analytics can improve any online business, in or out of the medical field, but plays a particularly unique role in the life sciences. Science seeks truth...
Quality & Compliance
Enhancing CRO Capabilities with Independent Physician Services
The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention...
The Quality of Your Medical Writing Matters (And Here’s Why)
Medical writers need to meet a few critical criteria before they publish their work. First and foremost, people want to see accuracy and explicit knowledge of the field when they’re seeking out...
Digital Transformation
Research and Development is More Important Than You Think
Research and development is a key component in the successful discovery and development of new drugs and medical devices entering the market. It’s also an area of big business, with investments in...
Data Integrity in Clinical Research: Audit Trail Review as a Key Tool
Data Integrity in Clinical Research: Audit Trail Review as a Key Tool A recent position paper from the eClinical Forum and the Society for Clinical Data Management highlighted the value of audit...
A Guide to the Clinical Study Report
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
The Role of Clinical Data and Clinical Data Science
Clinical data and its analysis are critical to clinical research. Ensuring the overall quality of clinical data is then paramount to ensuring quality care and appropriate decision-making in the...
How to Sustain Compliance with EU MDR (2017/745) After the Deadline
The Medical Devices industry breathed a sigh of relief for the new European Medical Device Regulation (EU MDR), but the May 2021 deadline is now right around the corner. The transition from the...
The Evolution of Medical Writing
Medical writers must not only have solid writing skills, but knowledge in the context and terminology of medical topics. At times, they may even need to analyze the logic of a passage. Examples of...
5 Ways the Medical Industry is Using Data Science
In the era of technological disruption, data science is a disruptor for the books. Today’s data scientists develop processes, algorithms, and systems to mine structured and unstructured data with the...
Regulatory Strategy in Pharma & Biotech Submissions Trial Design
Drug development can be a protracted and multifaceted process. This is often the case for startups and newer organizations, which may not have dedicated regulatory compliance departments and...
2020 Trends in Biopharma
COVID-19 has been the ultimate Big Pharma catalyst, as well as the biggest thing to hit biopharmaceutical news pages in decades. On the industry side, however, investors and observers remain mindful...
4 Hidden Obstacles to Clinical Trial Success
It's no wonder scientists begin clinical trials with great excitement: combine promising discoveries with the best test sites, scientists, and as many qualified, willing patients as possible, and off...
Lean Principles: A Life Sciences Overview
Today, with the FDA endorsing fewer new treatments, life sciences companies are pressured to develop better therapies while also struggling to control costs and retain their star employees. And while...
Quality & Compliance
Do You Need a Resource Management Team?
In the latest PMI report Pulse of the Profession 2020 (2020), 11.4% of surveyed organizations attribute investment waste to poor project performance. What defines project performance and ultimately...
Enterprise Resource Planning (ERP) Systems in the Medical Industry
Drug and medical device development and manufacturing is a complex process that involves multiple supply chains, various monitoring systems, and countless players from R&D to market. Due to the...