by Prakash Achaary | Aug 9, 2018 | Blog
It is evident that during numerous audits, while working for the FDA and at MMS, clinical investigators are enrolling ineligible study subjects. A few of the ineligible subjects receive waivers before enrollment, however many do not. Ineligibility is often not clear...
by Prakash Achaary | Jul 26, 2018 | Blog
Last month, the Federal Food, Drug, and Cosmetic Act (FDCA) turned 80 years old. On June 25, 1938, the FDCA was signed by President Franklin Roosevelt. It was passed by the 75th Congress as Public Law 75-717, 52 STAT 1040 to prohibit the movement of adulterated and...
by Prakash Achaary | Jun 28, 2018 | Blog
There are currently more than 70 approved Risk Evaluation and Mitigation Strategies (REMS) in the Food and Drug Administration (FDA) database. These structured programs are designed with specific goals to ensure that the benefits of drugs outweigh risks, while also...
by Prakash Achaary | Jun 7, 2018 | Blog
During PhUSE US Connect 2018 – the clinical data science conference – in Raleigh, North Carolina, MMS data science experts presented a paper and corresponding poster, titled Big Data Paradox: Development of a Unique and Repeatable Analytical Process while Implementing...
by Prakash Achaary | May 31, 2018 | Blog
The size of the global pharmaceutical market will reach $1.12 trillion by the year 2022, according to Pharmaceutical Commerce. Yet, many questions linger about what the future of drug development will look like, including technology that will impact the industry and...
