by Prakash Achaary | Dec 1, 2021 | Blog
FDA Expedited Program Designations to Support Rare Disease Drug Development By: Christine Clarke PhD, Senior Medical Writer One in 10 Americans is affected by rare diseases—more than half of which are children—and approximately 95% of the more than 7,000 rare...
by Prakash Achaary | Nov 3, 2021 | Blog
MMS Announces Second Annual Global Champions of Change Competition Winner: Colleague Participation in Organization Innovation By Jim Balcom, Director of Partnerships and IT Governance MMS has just concluded its second annual Global Champions of Change...
by Prakash Achaary | Oct 8, 2021 | Blog
How to use a Master Protocol to gain Efficiencies in a Clinical Trial By: Tasnim Hoda, Manager of Regulatory and Medical Writing and Aaron Burr, Senior Medical Writer The clinical development industry is an ever-changing field. It’s crucial to stay ahead of...
by Prakash Achaary | Sep 15, 2021 | Blog
Challenges of Rare Disease Drug Development Programs: Limits in Understanding, Patient Population, and Resources By: Amanda Beaster, Ph.D. Why is drug development and research in the context of rare disease frequently more difficult to address? In this blog, we will...
by Prakash Achaary | Aug 31, 2021 | Blog
Tips for Successful Medical Device Development and Approval By: Gary Pekoe, Senior Medical Writer. For Sponsors planning to manufacture or distribute a medical device in the US, understanding regulatory requirements is of the utmost importance. Medical device...
by Prakash Achaary | Aug 31, 2021 | Blog
How to Train Users on the Clinical Trial Information System (CTIS) Ahead of New Regulations. By: Kasim McLain, Manager of Transparency On 31 July 2021, the European Commission published a notice in the Official Journal of the European Union announcing that the EU...
