Clinical Trial Material Supplies

Efficient and reliable management of clinical trial materials is the backbone of successful clinical research. As clinical trials grow in complexity and scale, the need for a robust IMP management and supply chain solution becomes paramount.

At Bilcare GCS, we specialize in providing comprehensive Clinical Trial Material Supply (CTMS) services that ensure the smooth and efficient delivery of clinical trials. Our expertise includes services like primary and secondary blinding, labelling, packaging, and supply chain management, all tailored to the needs of our clients including but not limited to the following

  • Clinical Trial Packaging and Labeling Services

    • Primary Packaging
      Blister / Strip Packaging, High Speed Bottling, Tube / Vial Filling, Pouch Packaging
    • Secondary Packaging
      Protocol Specific Pack Design and Development, Kit Assembly, Wallets, Blister Cards, Labeling at Refrigerated Temperature
    • Label Design & Generation
      (Single / Multi Panel & Booklet Labels), Kit List Generation, Randomization, Text Translation Support, Country Specific Regulatory Review
    • Innovative Packaging Solutions
      Child Resistant Pack
  • Storage, Distribution and Global Logistics

    • Controlled Temperature (15-25 Deg C) (20-25 Deg C) / Refrigerated (2-8 Deg C) / Frozen (-20 Deg C) Storage, Deep Freeze Storage (-70 Deg C) & Nutraceuticals
    • Controlled Drug Substance Storage & Distribution
    • Vaccines, Injectables, Biologicals & Biosimilar
    • Storage & Distribution
    • Inventory Management through validated SAP S4 HANA ERP System
    • Building Management System for 24/7 Temperature and Humidity Recording
    • Transit Temperature Monitoring & Recording
    • 24/7 Live Tracking through Customer Web Portal
    • Global Storage & Distribution via Depot Partners Worldwide
    • Strategic tie ups with Global Logistics Service Providers
  • Regulatory Consulting & Qualified Person Services

    • Regulatory & Technical support throughout the overall Drug Development Cycle – IND, Clinical Trials, Marketing Authorization Approvals
    • Licensing support for DCGI, ICMR, CDSCO, Local FDA, DGFT, CBN Approvals
    • Import & Export requirements for Shipping and Pre-Clearance of Shipments
    • Auditory Services to support QP Declarations
    • QP Release Certificates
    • Global Auditing of Third Party Manufacturing, Testing, Packaging and Labeling facilities as required in support of QP Declarations for Import into the EU
  • Global Returns & Destruction

    • Handling Returns as per Customer Specific Protocols
    • Handling Destructions using a Govt. Approved External Agency
    • IVRS Controlled Drug Return & Destruction process to ensure optimization
  • Clinical Manufacturing

    • Formulations & Development and Analytical Services: Solids, Liquids, Creams, Injectables
    • Active & Placebo Manufacturing
    • Over-Encapsulation and Blinding
    • Pre-formulation and Development
    • Analytical & Pre-formulation Development
    • Advanced Analytical Services
    • Method Development and Validation Stability Studies
  • IWRS / ITR

    • Multilingual interactive systems for site administration, inventory and shipment management
    • Custom programming with accelerated implementation within 4 weeks
    • Customized IWRS Services

Value Propositions

End-to-End Services

From primary and secondary blinding to labelling and packaging, Bilcare GCS offers a full range of CTMS services including Manufacturing of IP and Placebo to ensure that your clinical trial materials are handled efficiently and in full compliance with industry regulations.

Global Reach

With a strong network and facilities across key regions, we are equipped to handle clinical trials on a global scale.

Customised Solutions

Every clinical trial is unique. We provide tailored services that meet the specific needs of your study, ensuring the integrity and reliability of your clinical data.

Regulatory Compliance

With our experience and deep understanding of global regulatory standards, we ensure that your clinical materials are compliant with all required guidelines.

Global Reach, Local Expertise

With operations spanning multiple countries, we combine global capabilities with localized expertise to navigate regulatory and logistical challenges seamlessly.

Ready to streamline your clinical trial material supply services?

Partner with Bilcare GCS to ensure high-quality, compliant services tailored to your needs. Get in touch today to learn how we can support your clinical trials with our robust CTMS services.