Regulatory and Medical Affairs
As a core service area at ClinicalRM, our Department of Regulatory and Medical Affairs provides our customers with an expert team of regulator personnel that are dedicated to sharing their knowledge of the complex regulatory environment. Our experienced staff is committed to the ever-changing regulatory climate through continuous education, trend analysis, and the awareness of industry standards. Utilizing a CTMS platform to manage workflow allows our team to streamline our regulatory knowledge and technology is our backbone of our regulatory department. From Regulatory Support, Safety Oversight and Pharmacovigilance, and the broad therapeutic expertise, our global network of experts provide a range of strategic services to support clinical trials in all stages of development. Providing regulatory consultation and ongoing assessment throughout the product lifecycle, and ensuring your data is submission-ready, is our undertaking. We pride ourselves in a “do the right thing” approach, while we tailor a sound strategy to keep your program on track.
Our Regulatory and Medical Affairs Department provides the following services:
- • Safety Oversight and Pharmacovigilance
- • Regulatory Support
- • Medical Writing/Statistical Analysis & Reporting