Euromed Clinical Supply Services (ECLISSE®) is a leading provider in the management of Investigational Medicinal Products (IMP) for clinical trials with more than 15 years of experience. We employ our scientific, regulatory and operational resources to structure customized and integrated solutions to manufacture your IMP. In this way, we help our clients to shorten timelines, reduce costs and optimize IMP concepts for packaging, labelling and logistics strategies and solutions.
Our Clients benefit by receiving expert Imp management services and comparator all from one convenient source.
ECLISSE is located in Cantu (Italy), nearby Milan. The production plant is equipped for manufacturing, stability analysis, packaging, labelling, batch release and certification. And therefore minimizes time and costs from idea to IMP availability.
From Idea to Concept — we work with the aim to bring your protocol to life, ensuring the maximum flexibility approach and small/medium size batch management.
Development of creative IMP concepts for phase I through phase IV trials. Our approach is in direct co-operation with project managers and clinical experts to identify and optimize IMP realization.
- Preparation of Emergency Envelops
- Preparation of IMP section relevant to the IMP preparation
- Preparation of IMP manuals for Investigators and Pharmacists
- Preparation of international Master Label Forms
- Selection of qualified packaging materials
- Tailored packaging and labelling designs to meet study needs
- Importation of IMP from extra-EU countries in agreement with EU requirements
At our manufacturing plant, we provide all IMP manufacturing and packaging in compliance with EU-GMP/CGMP and legal requirements.
- Placebo manufacture (capsules)
- Blinding of IMP – e.g., over-encapsulation of solid oral formulation
- Batch release and certification by QP
- Primary Packaging of solid oral formulations
- Packaging of all formulations and high potency drugs in cooperation with qualified partners
- Secondary packaging of all formulations and packaging designs at our own production sites
- Provision of user-friendly packaging materials, controlled to fit quality specifications
- Preparation of label text according to regulatory requirements
- Label design to enhance compliance of trial subjects
- Client’s corporate identity can be integrated into label
- Labeling with mono-/bi-/multi-lingual label (multi-language booklet label, wrap-around label, with or without documentation part/tear-off label)
- Robust procedures to avoid mix-ups
- Re-labeling in case of changes, (e.g., protocol amendments, new ‘use-by date’)
- Compliance with 2001/20/EC, GMP and national drug laws (e.g., AMG), protocol specifications
- Tear-off label to document subject compliance & drug accountability
- Stock management in our own warehouses
- h24 monitoring, mapping, and recording of temperature over the storage period (-80°C, 2-8°C, 15-25°C), including alarm notification for temperature deviations
- Electronic inventory for batch monitoring and tracking of SSU
- Set-up and maintenance of trial specific IMP inventory list
- Expiration date tracking and alarm notification
- IMP retrieval management
- Product recall procedures
Highly motivated and well trained IMP managers handle all IMP orders and oversee all shipments to investigator sites in compliance with legal requirements, Good Distribution Practice (GDP), and trial related IMP specifications. Global distribution using most reliable courier support is offered for international trials.
Accountability & Destruction
Services supporting sponsor regulatory requirements throughout the entire life of the clinical trial.
- Reconciliation of returned IMP in accordance with the client’s specifications
- Inventory and tracking of SSU in electronic inventory list
- Certificate of destruction