CTS Clinical Trial Supply

Providing you with a “full service”

Charité Research Organisation offers you a ‘full service’ solution. We act as both a classical Contract Research Organisation and a site all rolled into one. In other words, we can manage and physically perform the whole project for you. On other occasions we are offering a service which sits somewhere between ‘just’ being a site and being a CRO. In every model, you always benefit from the same level of expertise.

Clinical Trial Supply and GMP Compliance: The manufacturing, storage, and dispensing of investigational medicinal products (IMPs) and auxiliary medicinal products (AxMPs) are conducted under a GMP-certified manufacturing license in compliance with ICH Q7 guidelines. This includes adherence to stringent regulatory standards for both sterile and non-sterile production process.

Facilities and Equipment: The facilities are operated by highly qualified, regularly trained, and experienced professionals, including pharmacists, pharmaceutical technical assistants, and Qualified Persons (QP) responsible for QP release. Key facility features include:
- Monitored storage rooms for controlled environments 15-25°C
- Temperature-controlled areas: refrigerated (2–8°C), frozen (-20°C to -40°C), and incubators
- An aseptic production area classified as RRK A–D (ISO 4/5 to ISO 8) and a non-sterile room classified as RRK D (ISO 8)
- Secure storage for controlled drug substances
- A comprehensive monitoring system to ensure controlled environments for both manufacturing and storage

Manufacturing Capabilities: The facility supports the manufacturing of:
- Non-sterile products: hard capsules, tablets, and liquids for external and internal oral use
- Aseptic formulations: small- and large-volume liquids for parenteral administration

Customization and Preparation for Clinical Trials: IMPs are customized to meet specific clinical trial requirements, including preparation for oral (e.g., tablets, capsules) or parenteral (e.g., intravenous, subcutaneous) administration. Reconstitution services are provided as needed under the responsibility of the principal investigator to meet trial specifications.

Manufacturing Process: CTS manufactures IMPs and AxMPs by dissolving, diluting, filling, packaging and labelling, all under a manufacturing authorization in accordance with German drug law (§13 AMG). The initial IMPs, provided by sponsors, are tailored to manufacture subject-specific / patient-specific IMPs. They are manufactured as aseptic infusion solutions and injection solutions and filled as non-sterile products from bulk bottles into capsule boxes / dosage cups.

Quality Control: CTS ensures the quality of IMPs and AxMPs through rigorous quality control measures, including visual inspection for visible particles, stability testing, other additional analysis on demand to meet study-specific requirements.

Packaging and Labeling: The Packaging of capsules, tablets, liquid, and semi-solid pharmaceutical forms, along with primary and secondary labeling, are carried out in full compliance with European Union legal requirements.

Clinical Trial Logistics: CTS provides comprehensive logistic services to ensure the secure and efficient handling of IMPs and AxMPs throughout the clinical trial lifecycle. These services include: site-to-site logistics, expiry date extension, reconciliation, and destruction.

Advantages for Sponsors:

Faster trial execution: Efficiency and faster timelines are achieved through the immediate availability of high-quality drugs, eliminating delays from external manufacturing while reducing logistical complexity and costs. The CTS facilities are located directly within the site, allowing the IMP and AxMP to be handed over directly to the physician. This eliminates the need for transfer to a clinical site.
Quality and Regulatory Compliance: Our GMP-certified manufacturing process ensures the IMP meets stringent regulatory requirements for safety, quality, and consistency, which is crucial for regulatory approval and trial integrity.
Real-Time Tailored Manufacturing: Enables seamless collaboration between researchers, clinicians, and manufacturing teams to rapidly manufacture IMPs to meet specific trial requirements, including small batches for dose-escalation studies, while allowing for immediate adjustments following protocol changes, and adapting to different dilutions as needed.

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Providing you with a “full service”

CTS Clinical Trial Supply