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Clinical Trial Supplies

Clinical Trial Supply Services

We offer Specialized Services in the area of Clinical Trial Supply management using our global network of assets, our experience and expertise in streamlining the Clinical Trial Supply process, thus ensuring that the study drug is available where you need it and when you need it. Our integrated offering ranges from the manufacturing to the supply of GMP Clinical batches. Our advanced software, ‘Trak Pack®’, tracks the movement of the batch supplies across the supply chain.


Services Offered

  • Clinical Batch Manufacturing
  • Clinical Batch Packaging
  • Support Services
  • Trak Pack®: Manufacturing & Distribution Tracking System

Clinical Batch Manufacturing

  • Manufacturing of drug product andmatching placebos
    • Product development of solid dosage forms
    • Clinical Manufacturing for BA / BE studies
    • Scaling up through Phase I to Phase IV
  • Over-encapsulation
    • Over-encapsulation of tablets or capsules
  • Product blinding
  • Sourcing of Comparator drugs or con meds
  • Handling of potent compounds such ashormones, OCPs and Cytostatic compounds
  • Analytical method development and drug stability programs
  • Clinical batch manufacturing offered fromsites in Ahmedabad, India and Morpeth, UK
  • Batches supported by QC testing and QPrelease from UK for trials into EU

Clinical Batch Packaging

  • Clinical Batch Packaging
  • Solid dose bottling and multi dose blistering capabilities
  • Hot and cold seal walleting and blister carding capabilities
  • Labelling
    • Artwork design
    • Translation services
    • Randomisation
    • Label printing
    • Patient kit assembly

TrakPack

Manufacturing & Distribution Tracking System

TrakPack® is a proprietary, real-time, protocol tracking system used, from project initiation through to the patient kit arrival at the clinical site.

  • TrakPack® has the following benefits
    • Is a secure web-based GMP validated application
    • Integrates with IVRS
    • Tracks the assembly, storage and distribution to the individual kit level
    • Utilizes barcode verification for key stages of manufacturing and logistics
    • Has a configurable customer interface forreal-time tracking
    • Fully 21CFR part 11 compliant

Support Services

  • QP services
    • Certification of individual batches following authorization by EU member state for clinical trial to proceed
    • QP release certificates for batch releases and re-issuance if further countries are added in the clinical trial
    • Auditing documentary evidence to support QP declaration
  • Returns and Destruction
    • Management of post study drug returns, reconciliation and destruction

  • Contact Us:
    Amar Karandikar
    Head Business Development, Formulations (North America)
    Landline: +1 732-686-5319
    Email: amar.karandikar@piramal.com