ethica provides a complete line of clinical trial supplies management services to support your clinical trial including customized drug packaging/labeling, randomization (central and site-administered) and study supply distribution. Streamlined interaction between our Clinical Operations and Quality Assurance departments ensures compliance with GCP/cGMP Guidelines and ethica's own stringent SOPs. With a proven ability to provide rapid and accurate response to study amendments and modified study logistics, we can ensure that your clinical study continues uninterrupted. Our services include: - Development/management of distribution and storage logistics for all clinical supplies (study drugs/devices, CRFs, study binders, all study related documentation)
- Development/management of randomization logistics including randomization envelopes, customized blind-breakable drug labeling, code break management and reports, etc.
- Coordination of placebo design and manufacturing (tablets, capsules, creams, ointments, gels, etc.)
- Manufacturing of participant- and protocol-specific kits using bulk oral/topical medications
- Management of all aspects of study drug reconciliation and inventory/distribution reports
- Service alliances regarding specialized drug packaging and blinding techniques (e.g., blister packing, re-encapsulation, etc.).
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