Clinical Trial Services

High-quality active pharmaceutical ingredients (APIs) are core to the manufacturing of safe and effective drugs for clinical trial services. MRIGlobal provides process chemistry optimization, scale-up production, and cGMP manufacturing of APIs. Our team works in compliance with current Good Manufacturing Practices (cGMP) to support manufacturing of early stage clinical investigatory materials.

Good formulation development focuses on delivering sound clinical trial services and material to the customer. MRIGlobal offers formulation support for various dosage forms, along with cGMP manufacturing services to support clinical trial needs.

Our team has more than 50 years of experience in analytical chemistry support, and our facility is fully equipped for tailored performance based on our customers’ needs. MRIGlobal excels at providing phase-appropriate support from the earliest phases of drug discovery and preclinical development, through all stages of clinical development. The pharmaceutical analysis team can also provide ICH stability testing, including development and validation of stability indicating methods, and performance of short- and long-term stability protocols. Our fully programmable chambers can handle RoW studies and other specialized conditions.

MRIGlobal’s unrivaled pharmaceutical repository facility is a full-service offering that provides proper receipt, storage, and distribution of drug substances and drug products for clinical trials. Our group can also manage reference standards, offering a centralized, discreet third party location and bulk materials such as excipients and retention samples. Coupled with drug product manufacturing, our group offers packaging (or re-packaging), labeling, and release testing for a wide array of clinical trial materials. MRIGlobal also operates a foreign trade zone to assist with international materials, and we can provide support for international distribution and importation for a variety of countries. 

To further support clinical trials, MRIGlobal operates a biorepository for preclinical and clinical biospecimens. Our team will ensure that all materials, whether they are clinical trial materials, reference standards or biospecimens, are safely secured throughout the course of your study through our 24/7 security monitoring, environmental mapping and power supply backups.