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CLINICAL TRIAL SUPPLY

CLINICAL SUPPLIES MANUFACTURING » BLINDING & RANDOMIZATION» PACKAGING & LABELLING SERVICES» CTM Storage» DISTRIBUTION SERVICES» RETURNS RECONCILATION & DESTRUCTION SERVICES»

 


 

 


 


 

Rubicon provides a range of services for clinical trial supplies (CTS) manufacturing which are undertaken at Rubicon’s cGMP facility with support from R&D facility. This service spectrum includes,

  • Manufacturing of oral tablets / capsules (active and placebo)
  • Encapsulation of tablets, multi-particulates, capsules and other solid dosage forms
  • Capsules filling for – Powder + Pellets ; Powder + Tablets; Capsule in Capsule
  • Functional coatings (Glatt), aesthetic coating of solid dosage forms
  • Bilayered tablets, Inlay tablets, Compression coated tablets

The development of matching placebo and de-blistering and repackaging of reference products is also undertaken at this facility.

Rubicon offers a range of solutions for blinding and randomization of products and can carry out blinding for actives, placebo and comparator. Over-encapsulation is one such option which requires the flexibility to produce batches ranging from hundreds to millions of capsules in a cost effective and secure manner. Rubicon has the necessary infrastructure and expertise to provide over-encapsulation services.

Rubicon can generate randomization codes as per the study protocol. Patient will be allocated to active or placebo groups as per this randomization list.

Rubicon provides a wide range of packaging solutions in clinical trial drug supply. At our facility, primary packaging can be carried out in bottles and blisters. High-density polyethylene (HDPE) and glass/PET bottles are used for bottle filling packaging. Blister packaging is conducted using polyvinylidene chloride (PVDC)-coated polyvinyl chloride (PVC) films, Aclar films and Alu-Alu foils. Powder/Granules filling is carried out in pouches, and creams and ointments filling in tubes.

Rubicon provides multiple options for secondary packaging including wallets, blister cards, cartons, boxes etc. Rubicon can provide different types of labels including booklet labels and tear-off labels. We offer protocol driven patient supply kits. Our labeling and assembly services includes open label, double-blind labels and un-blinding/decoding envelops.

Rubicon offers Clinical trial material (CTM) warehousing depot services. Some of the warehousing and supply services highlights include:

  • Customized inventory management service-Rubicon provides ‘e-room’ facility for its clients to monitor the inventory online through an exclusive login id and password
  • Round the clock power back up
  • 24/7 temperature control, monitoring and alarm system for temperature excursions
  • Access control with 24hr security
  • Global Distribution and Tracking (Tie-up with global logistics company)
  • Compartmentalized storage facility with following temperature conditions:
    • 15 0C – 25 0C (Quarantine / Bulk Storage / pick and dispatch rooms/ return and destruction room)
    • 2 0C – 8 0C (walk-in cold room)
    • - 20 0C (Refrigerator)

Every activity under clinical trial supply service spectrum is performed using comprehensive SOP’s.

Rubicon provides complete shipments of the drugs to many investigational sites and in different countries. Rubicon’s Distribution Management Services offers

  • Adherence to Good Clinical Practices (GCP) and cGMP regulations
  • End to end tracking of the drug throughout the value chain
  • Reliable and efficient accountability processes so that drugs are reconciled, returned, and destroyed appropriately
  • Inventory reports

At every phase of the project, accountability of clinical trial supply is maintained. We offer possible pick up from clinical trial site with receipt and verification and reconciliation is performed accordingly.

The destruction of all investigational products is documented and these destruction activities are handled in a separate area. We have a tie-up with a government approved destruction management service provider. A destruction certificate is provided to ensure legal and environment-friendly destruction.