Phase 1 & 2 Clinical Trial Design and Clinical Research Organization (CRO) Management
The IRISYS team has expertise that covers the entire development path, including Phase 1 and Phase 2 clinical trial design, organization and supervision.
Phase 1 clinical trials are designed to determine the metabolic and pharmacologic actions of a new drug, the side effects associated with increasing doses, and, if possible, to ascertain effectiveness. Phase 1 clinical trial designs are also used to evaluate drug metabolism, structure-activity relationships, and mechanisms of action.
Clinical trial design is especially important for Phase 1 studies in order to obtain sufficient information about the drug’s pharmacokinetics and pharmacological effects. IRISYS will help you confirm that your Phase 1 trial design can provide the data necessary for the design of scientifically valid Phase 2 trials.
Phase 2 clinical trials are intended to obtain preliminary drug efficacy data for patients with a particular disease or condition. Proper Phase 2 trial design can help determine the common short-term side effects and risks associated with the drug.
IRISYS also has a successful track record of working with the CRO pharmaceutical industry. We can help you select, work with, and supervise your CRO as needed.
Clinical trial design
IRISYS is well-versed in Phase 1 and Phase 2 clinical trial design, methodology and reporting requirements. We will work with your clinical staff to create a study plan specific for your needs.
IRISYS will identify a Contract Research Organization (CRO) that provides clinical trial services appropriate for your product and we will manage interactions on your behalf.