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...
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...
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,’...
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...
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...
