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...
FSP partnership models, when developed to find the right level of oversight, scale, pricing, and governance to meet a Sponsor’s needs, offer a functional provider solution that can benefit an organization in a rapidly evolving pharmaceutical industry. For example, The...
Attention Sponsors, Be Prepared to Publish Your Interim Clinical Study Results Right now, imagining that Sponsors would be required to publish the results of their interim analysis before the end of the study seems impossible. However, this will eventually become an...
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 delivering...
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...
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. Subjects in a clinical trial differ by myriad factors. Age, gender, and weight...
Planning, timing, and coordination. These three words may be the magic formula that Sponsors will have to adopt when the European Clinical Trials Regulation comes into force. Sponsors will have to prepare their timelines well to...
For many scientists and healthcare professionals involved in developing new medicines, patients, the people who represent the unmet need, are a primary motivating factor. To ensure that patients and physicians can make full use of a product’s potential, conveying...
[Fill out the form below to register] Abstract: When planning an Investigational New Drug (IND) or Clinical Trial Authorization (CTA) submission, navigating FDA, EMA, and other regulations can be challenging and creating scientifically-sound strategies are...