MMS Holdings Launches New Application
MMS Holdings, a data-focused CRO, has announced the launch of Automatiqc (pronounced: automatic.) Automatiqc is a new cloud-based application that performs quality control and style checks for medical writing, pharmacovigilance, clinical trial transparency, and other types of documents in the pharmaceutical, biotechnology, and medical device industries.
This new application is customizable, enabling users to tailor the software to client style guides including journal requirements and other established guides. Automatiqc does not require special training. Automatiqc can be used for any Microsoft Word-based document type including, but not limited to:
- Clinical Study Reports (CSRs)
- Protocols and Investigator’s Brochures (IB)
- Module 2 IND and NDA submission documents (M2.5, M2.7.1, M2.7.2, M2.7.3, M2.7.4, M2.7.5, and M2.7.6)
- Module 5 Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
- Health Authority Responses and Response to Queries (RTQs)
- Safety Narratives and Risk Management Plans (RMPs)
- Publications for peer-reviewed journals and more!
This new application is currently available for use through a service relationship with MMS or licensing of the application as software-as-a-service.
For more information, visit www.mmsholdings.com
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
