The clinical development industry is an ever-changing field. It’s crucial to stay ahead of industry changes and ensure compliance with the needs of health authorities. Experienced medical writers understand the purpose of a trial and work closely with the study team to recognize efficiencies that may impact the study design or the long-term success of the clinical study.
Why is drug development and research in the context of rare disease frequently more difficult to address? In this blog, we will outline some of the challenges with rare disease programs.
For Sponsors planning to manufacture or distribute a medical device in the US, understanding regulatory requirements is of the utmost importance. Medical device development and approval are regulated by the FDA, under the jurisdiction of the Center for Devices and Radiologic Health (CDRH).
On 31 July 2021, the European Commission published a notice in the Official Journal of the European Union announcing that the EU Portal and Database, a key component of the Clinical Trial Information System (CTIS), is fully functional.
For its leadership and culture as a clinical research organization (CRO) in the pharmaceutical industry, MMS has received much recognition and praise recently.
To uncover some of the reasons behind this success, we recently sat down with Prasad M. Koppolu, Chief Operating Officer (COO) at MMS
How to Maximize FSP Partnerships - Scalability, Innovation, and Efficiencies. by Donnelle LaDouceur, Director of Functional Service Solutions FSP partnership models, when developed to find the right level of oversight, scale, pricing, and governance to meet...
Attention Sponsors, Be Prepared to Publish Your Interim Clinical Study Results By Karim Ibazatene, Associate Director of Clinical Trials Transparency Right now, imagining that Sponsors would be required to publish the results of their interim analysis before the end...
Combination Products: Understanding and Appreciation of CMC Regulatory Considerations for Successful Submission Planning Whitepaper [Fill out the form below to access the whitepaper] Combination products have emerged as powerful technologies for...
Over the past year, many professionals in clinical research have had to navigate through uncharted waters and adapt to remote auditing due to the COVID-19 pandemic. While the landscape of auditing has changed, the basics of confirming compliance remains the same. Almost any audit can be conducted successfully while remote if limitations are recognized and managed appropriately.
Clinical research is very complex, mainly because the questions we answer are almost always multivariate problems, and machine learning can aid clinical researchers in making sense of it.
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