CANTON, Mich. (July 28, 2021) – MMS Holdings (MMS) – an award-winning, data-focused CRO – announced that its learning arm, MMS Academy, has expanded its global training portfolio with the launch of new courses in inspection readiness and clinical programming. These new courses – created by industry-trained subject matter experts – will give students and working professionals the opportunity to gain the critical knowledge that the pharmaceutical, biotechnology, and medical device industries require.
Virtual inspection readiness training
In the 14-week inspection readiness course, students will gain an understanding of global health authority (i.e. FDA, EMA, etc.) inspection processes, targeted industry-specific guidance, and important regulations and guidelines that allow teams to ensure successful regulatory authority inspections.
Mini courses are also available, each lasting three to four hours, and have been prepared with consideration for a variety of specific inspection needs, including: remote inspections, regulatory agency and ISO basics, post inspection management, GMP, Sponsor and CRO inspections, and more.
“Preparing for regulatory inspections is essential in our industry, creating a critical need to have actionable, tested training for life sciences professionals at all levels,” said Michelle Gayari, Executive Vice President, Global Operational Excellence and Innovation, MMS. “Being unprepared for one inspection is all it takes to greatly delay a new drug or therapy. The skills of those who take this course are set to gain will help prepare them for successful inspections and a more successful future.”
Hands-on clinical programming coursework
Intermediate Fundamentals of Clinical Programming, an 8-week course, is designed for intermediate SAS programmers looking to learn more about the CDISC SDTM model. Those taking this course will gain the confidence to model clinical trial data into SDTM domains and a level of expertise to draw upon when engaged in real-world projects.
This course provides an understanding of:
- Converting clinical data into SDTM format by understanding the required modeling of the General Observation Class and targeted domains
- The components included in define.xml v2.0
- The process of third-party validation of the define application
- How to resolve and apply corrective measures to ensure modeling is in compliance with SDTM standards
“Traditional colleges will teach students how to program, but few teach how to support the needs of our industry specifically,” said Jim Bademian, Director of Statistical Programming and Data Management, MMS. “Many learn that on the job, and MMS Academy is here to help speed up that real-world learning process to create stronger programmers.”
New courses in the pipeline
MMS Academy continuously works to expand its global training portfolio for students and working professionals. New courses on data science and pharmacovigilance are planned to launch later this year.
MMS Holdings (MMS) is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years.