Clinical Trial Materials

SRI's State of the Art Pharmaceutical Formulation Development Facility includes a Class 100 Cleanroom suite and provides pharmaceutical and biopharmaceutical companies with a single, quality resource for the manufacture of parenteral, oral, topical and other Clinical Trial Materials. These drug formulation activities are supported by our Quality Assurance Unit, which inspects, tests and audits the studies for full compliance with regulations of the FDA and international regulatory agencies. All SOPs for cGMP guidelines are strictly followed.

Our services include:

• Blinding of tablets and capsules and the production of matching placebos
• Conventional capsules and also the full range of double blind capsules available from Capsugel®.
• Over encapsulation of tablets/capsules for blind trials
• We provide blister packaging and can supply custom packaging for superior presentation and patient compliance.
• Printing of tear-off and double blind labels
• Storage of materials and distribution to the clinical sites
• Batch capacities include 50 L for liquids and up to 100,000 units of tablets or capsules.
• We specialize in highly potent compounds
• Manufacture materials primarily for phase 1 and in some cases phase II.

SRI performs formulation and clinical manufacturing in a single location, enabling us to move your product into the clinic 2-3 months faster than our non-integrated competitors. SRI can manufacture virtually all dosage forms including solids, liquids, injectables and novel drug delivery systems. SRI also has particular experience with aerosol drug delivery, including device design. We have the expertise to deliver both small and large molecules systematically via aerosol as an alternative to the injections often used for peptides and proteins.

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     Last Updated Jul 17, 2008