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Clinical Trial Materials Packaging & Labeling

DDL supports sponsors undertaking a wide range of clinical studies, from small open-label Phase 1 though large multi-center multi-national randomized, double-blind Phase 3 studies. All types of investigational products (IP) can be accommodated: orals, injectables, semi-solids, patches, etc., with labeling of primary packaging including bottles, vials, blister packs, sachets, and tubes. IP requiring special storage, e.g., cold or frozen, or handling, e.g., light sensitive, can be accommodated.

Topical Clinical Trial Materials Packaging

Clinical Trial Materials Packaging, Labeling & Distribution 

The work is conducted in accordance with the specific clinical trial protocol and FDA Current Good Manufacturing Practices (cGMP), 21 CFR 211. All appropriate GMP documentation, including Quality Standards, Master Label Text and Copy, Assembly Records and Labeling Job Summary are generated, review, approved and executed.

Labeling and Assembly

Investigational products are either manufactured by DDL or are provided by the sponsor. Dependent upon the clinical needs, single-panel or double-panel labels are designed, printed and manually affixed to the primary packaging. Secondary packaging can be configured to hold a single product or multiple products as determined by study requirements. As needed, subject kit cartons will be designed, sourced, assembled and labeled. Subject kits may be assembled into block boxes if appropriate.

Randomization codes may be needed for the study; DDL works with clients to generate randomization per study specification or accommodates the importation of codes from external sources. DDL also works with clients utilizing Interactive Web Response Systems (IWRS) for management of study drug supplies.

Temperature-Controlled Storage and Distribution

Packaged, labeled investigational products are stored at the DDL warehouse until being distributed to clinical sites in the US as well as ex-US including Australia, Canada, Latin America and the EU. Labeled supplies are shipped utilizing temperature monitors and insulated shippers pre-qualified for controlled room temperature (15°C-30°C) or for refrigerated condition (2°C-8°C).

DDL may also serve as storage depot, with clinical material inventory stored under GMP in controlled temperature conditions, and distributed upon request, such as for resupply or for studies involving multiple cohorts over time.

Returns, Reconciliation and Destruction

Returns and reconciliation of supplies is provided during close of the trial. Destruction of materials may be conducted upon request, and a Certificate of Destruction provided upon completion.