Bilcare Global Clinical Supplies - Clinical Trial Materials Support, Services and Project Management

Bilcare Global Clinical Supplies (GCS) serves the Americas, Europe, and Asia with clinical trial materials support, services and complete project management. The FDA registered US operation is DEA licensed for controlled substances Schedule I-V. Bilcare also has a MHRA licensed European location in Wales, UK.

Bilcare’s global reach extends to Asia with a facility in Pune, India. Globally, Bilcare GCS provides best-in-class services for clinical supplies management, research and distribution into more than 50 countries.

Our services for solid, semi-solid, liquid, DEA(CI-V) and biotech clinical trial materials (CTM) satisfy a broad range of requirements; from pre-formulation research and development, analytical services and clinical supplies packaging and labeling, to IVRS, controlled temperature (cold and frozen chain) CTM storage, distribution worldwide, and returns and destructions accountability.

Our integrated approach provides you with seamless service throughout your entire project. We combine our industry experience and our total clinical supply chain service and delivery to provide smart, efficient and innovative solutions.

CLINICAL SUPPLIES PROJECT MANAGEMENT

Drawing on our experienced project management team and our ability to fully integrate innovative solutions and services throughout a drug’s clinical trial life cycle, Bilcare GCS can help you optimize the clinical trial process.

PRE-FORMULATION OF CLINICAL TRIALS

Bilcare GCS has a range of innovative and thorough pre-formulation capabilities to support your product’s clinical trial program, including:

• Physical properties
• Product characterization
• Chemical compatibility and reactivity to packaging substrates

FORMULATION

Following the determination of the appropriate composition, the Bilcare GCS formulation staff focuses on the development of the process for making clinical trial material. Typical areas of focus for processing parameters include:

• Determine blending times for tableting and encapsulation
• Identify suitable means of blinding comparators
• Develop both ethical and over-the-counter products

PHARMACEUTICAL ANALYTICAL RESEARCH

Bilcare GCS provides the best solutions for every stage of your product development through the clinical trial process. Our range of analytical services cover in-depth drug research, as well as packaging materials, components and systems. Some of these capabilities include:

• Develop appropriate methods for cleaning qualifications of manufacturing equipment
• Competitor analysis for unbiased de-formulation
• Method development and validation for all phases and components in development

CTM TESTING

Whether the sample is a release for clinical trial or an 18-month stability sample, we will test the sample promptly and issue the corresponding documentation. The testing from our service group extends throughout the life cycle of your clinical trial material.

CLINICAL MANUFACTURING

Once a drug has been formulated, Bilcare has a manufacturing facility that provides fast, efficient and agile manufacturing of solid dosage forms as well as liquids, creams, and ointments. Our unique approach enables us to support customer requirements for short-term studies as well as large-volume ongoing projects.

CLINICAL PACKAGING

Our extensive experience makes us uniquely qualified to design and prepare your clinical supplies. We help you select the right packaging solutions, complete production and deliver a final product that meets your high standards through comprehensive packaging research that produces the best, customized and innovative clinical packaging materials.

PHARMA LABELING SERVICES

Bilcare GCS provides support with the following labeling services and innovations for your product:

• Label production and printing capabilities
• Randomization
• Label application and kit assembly

GLOBAL LOGISTICS AND DISTRIBUTION

Bilcare GCS can store and ship your materials into 50 countries worldwide. Our expert technicians and project managers handle, store and distribute your product. Customer and project specific distribution protocols designed at the start of each study ensure that all of your expectations are met.

THE BILCARE QP SERVICES TEAM

Bilcare GCS has a team of six Qualified Persons (QPs) with wide experience in the manufacture and supply of investigational medicinal products. QPs are assigned projects according to their specialized expertise and have personal and legal responsibility as described in the EU Clinical Trial Directive (2001/20/EC) to ensure the investigational products are produced in accordance with EU GMP and the clinical trial authority.