The majority of phase I and phase II clinical trials use a diluent/placebo to allow the range of doses required in the trials to be prepared by dilution or reconstitution in the clinic. MasterPharm is one of the few companies that can provide these products routinely to the standard required by the regulators. Companies face continual pressure to get products to market quickly, and cost effectively and MasterPharm believes that a sponsor’s focus should be on the active and the formulated drug product, and not on the diluent/placebo.
Masterpharm’s agile size and highly qualified workforce – along with our customer-driven work culture – mean that every project is tackled quickly and delivery assured. Typically lead times are 6 to 8 weeks after an order is received, and shipments can be made directly to your clinical site.
MasterPharm’s focus is on Terminally Sterilized products, which are compounded in ISO5 (Class-100) clean rooms.
Our terminal sterilization cycles have been qualified for vials in the range 1ml to 50ml.
MasterPharm Compounding Pharmacy employ pharmacists, quality assurance and other personnel that have experience performing clinical trials. Our pharmacists bring a wide variety of additional knowledge with their experiences working in hospitals, community pharmacy settings, chemical industry, and commercial pharmaceutical manufacturing.
MasterPharm Compounding Pharmacy Services, has provided clinical trial service for sponsors, large and small. Here are a few of the sponsors we have served:
- Gilead Pharmaceuticals
- Innotek Pharmaceutical
- Anterios Pharmaceuticals
At MasterPharm we recognize the complexity of successful initiation and completion of any investigational new drug clinical trial depends on a close, flexible relationship between all parties. MasterPharm Compounding Pharmacy is capable of explaining regulatory expectations of risks and rewards of the project to the sponsor.