New Protocol Set Up 

Includes protocol, investigator brochure and pharmacy manual review, site-initiation visit attendance, pharmacy binder preparation (including requesting pertinent pharmacy documents from the sponsor), ensuring all ancillary supplies are available as well as development of dispensing guidelines. 

Randomization 

Offered for studies that require randomization by pharmacy staff. 

Storage and Maintenance of Study Drug and Supplies Required for Protocol Compliance 

Includes 24/7 temperature monitoring of IP storage environments, ranging from room temperature to Ultra-low Freezer environments. Temperature reports are available upon request. CIRP has storage capacity for various products including hazardous, scheduled and biologic products. 

Drug Preparation & Dispensing of Study Drug Product 

Includes preparation and dispensing of various drug formulations including Oral, IV, subcutaneous, topical etc… and their equivalent placebo formulations when applicable. Blinding procedures are followed when applicable. We provide sterile compounding for various medications including hazardous, scheduled and biologic products and are USP <797> compliant. We also document and maintain accountability records for our investigational products. 

Drug Return/Destruction 

After approval from the sponsor, investigational product may be returned back to sponsor or onsite destruction is available. 

Purchase of Protocol-Related Medication, Equipment and Supplies 

Therapeutic Dosing/Monitoring 

Therapeutic dose adjustments, monitoring and interpretation of levels associated with investigational product. 

Sponsor/Monitor Visits 

We work directly with study monitors during Site Qualification visits, Site Initiation visits, regularly scheduled monitor visit, close out visits and any audit visits. 

Study Document Storage Fee

At the close of all our trials, pharmacy binders are stored long-term by a 3rd party vendor. If documents are requested after a close-out visit has taken place we will facilitate the retrieval of those documents from long term storage.