MMS Holdings Expert Insights Blog

Experts at MMS share their insights on trending
topics in the pharmaceutical industry.

Building a robust clinical data science process

Building a robust clinical data science process

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...

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Ask the Expert: The Future of Drug Development

Ask the Expert: The Future of Drug Development

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...

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Why Should GDPR Matter to all Clinical Research Firms?

Why Should GDPR Matter to all Clinical Research Firms?

Since the beginning of 2018, there has been a growing interest from pharmaceutical and biotech firms in the United States regarding the basic tenets of the European Union’s (EU) new General Data Protections Regulation (GDPR) law. With more than 50 percent of all...

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Start plain language summaries early or get left behind

Start plain language summaries early or get left behind

In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft lay or plain language summaries for phase 2-4 clinical trials. These lay summaries need to...

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FDA Furthers Transparency Push with CSR Release Pilot

FDA Furthers Transparency Push with CSR Release Pilot

The FDA provided insight into their overall vision for clinical trial transparency last week, announcing a new program to publicly release clinical study reports (CSRs) that accompany drug approval submissions. They plan to pilot nine recently-approved drugs (yet to...

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Big Improvements in Clinical Trial Transparency Compliance

Big Improvements in Clinical Trial Transparency Compliance

Bioethics International recently published their second, long-promised Good Pharma Scorecard, a ranking of large biopharmaceutical companies’ compliance with disclosing data for new medicines to public registries, in BMJ Open. With this recent publication, a spotlight...

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