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Automatiqc™: Bridging the Gap Between AI Precision and Human Expertise in Medical Writing and Quality Control

Automatiqc™: Bridging the Gap Between AI Precision and Human Expertise in Medical Writing and Quality Control

by Prakash Achaary | Aug 16, 2023 | Blog

In today’s fast-paced world, the blend of technology and human expertise is transforming various industries, including Clinical Research Organizations (CROs). At MMS, we lead this change, tapping into state-of-the-art technology while valuing the unmatched role...
Single-Arm Trials and Drug Approval in the European Union (EU)

Single-Arm Trials and Drug Approval in the European Union (EU)

by Prakash Achaary | Aug 2, 2023 | Blog

The Vital Role of Regulatory Strategists, Biostatisticians, and Clinicians in Protocol Development Recently, there’s been a growing focus on using single-arm trials as primary evidence for drug authorization in the European Union (EU). Given this, the role of...
3 Tips for CSR Writing: Best Practices for Lean and Effective Clinical Study Report Writing

3 Tips for CSR Writing: Best Practices for Lean and Effective Clinical Study Report Writing

by Prakash Achaary | Jul 6, 2023 | Blog

A clinical study report (CSR) describes the conduct and results of an individual clinical trial. The CSR is a component of regulatory submissions (i.e., the Common Technical Document) and is essential for ultimate approval. Lean CSR writing is ‘focused writing,’...
EMA Policy 0070: Much Awaited Revamp for Clinical Trial Transparency

EMA Policy 0070: Much Awaited Revamp for Clinical Trial Transparency

by Prakash Achaary | Jun 28, 2023 | Blog

On May 16th, 2023, EMA conducted a much-awaited webinar to address the phased restart of EMA Policy 0070 after almost five years of suspension. The restart will come into effect in September 2023. The EMA initially introduced the clinical data publication Policy 0070...
The Role of Quality Assurance in Outsourcing: Ensuring Regulatory Compliance and Quality

The Role of Quality Assurance in Outsourcing: Ensuring Regulatory Compliance and Quality

by Prakash Achaary | Jun 12, 2023 | Blog

The role of Quality Assurance (QA) in outsourcing is important for sponsors to reduce business risk, time and effort.  In the pharmaceutical industry, vendors can support any aspect of the product’s manufacturing, testing, labeling, or distribution. However, the...
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Recent Posts

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  • Relaunch of EMA Policy 0070 in September 2023: The European Medicines Agency’s Revived Commitment to Transparency
  • “D” is for Discipline: Everything You Need to Know About FDA’s Type D Meetings

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