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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
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...
Improve your R&D Strategy with These 6 Tips
In 2017, R&D investments in the pharmaceutical space reached more than $70 billion, with projected figures of over $200 billion by 2024. Pharma is one of the two sectors with semiconductors that are...
5 of the Most Common Biopharma Risks Today
Spending on prescription drugs in the United States is expected to reach $600 billion by 2023. The continuously increasing need for pharmaceuticals is mostly driven by an aging population, a rise in...
Quality & Compliance
A Guide to Clear-Cut Planning and Program Execution
The landscape of clinical trials and other clinical development projects has dramatically changed in recent years. Progress made in scientific discovery is paving the way to novel therapies and...
5 Scenarios That Need a Clinical Operations Team
New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today's landscape puts sponsors under more pressure than ever before. Clinical trials are becoming...
Do You Need a Project Management Office (PMO)?
There is more to a project management office than managing projects. In fact, the project management office (PMO) acts as both a watchtower and a lighthouse to guide strategic initiatives toward...
7 Medical Writing Tips for the Oncology Field
In the wake of the 21st Century Cures Act (December 2016), the FDA has switched gears to accelerate the development of novel therapies and speed up the review process, particularly in the field of...
Clinical Research Solutions
Changes in Medical Device Regulatory Requirements in Europe (2021)
In May 2021, the new European regulations on medical devices (EU MDR) will take full effect. Organizations face a unique set of compliance challenges, mainly due to the numerous changes and additions...