Integrated Clinical Trials Services

Integrated Clinical Trials Services

Backed by years of pharmaceutical industry experience, we provide focused, flexible, responsive collaboration to ensure the most efficient and cost-effective solutions for your overall clinical trial strategy

Project Management Distribution Returns, final reconciliation and destruction

Project management

The importation and distribution of IMPs and comparator drugs require extensive planning and knowledge of different country-specific rules and customs regulations to ensure that shipments are not delayed.

 

We provide our clients with a dedicated project manager with an extensive and relevant experience in dealing with stringent regulatory, packaging and logistic requirements.

research Operation Excellence

Warehousing & Distribution

Our cGMP validated and monitored warehousing provides clinical trial supply chain management. Our facility features:

  • Validated and dedicated temperature storage areas for drugs, their components, and ancillary materials;
  • Controlled room temperature and humidity monitoring;
  • Multiple storage modes (ambient, refrigerated +2/+8 and frozen -20°);
  • Controlled drug area;
  • 24/7 alarmed monitoring of all products and all temperature ranges;
  • Limited-access and security-enabled storage areas.

Clinical supply chains are complex and require consistency between packaged patient kit release, inventory control and patient kit tracking to the investigator site: our dedicated logistics team works to ensure safe and timely delivery to all Italy supported by our distribution tracking system: our staff are highly experienced in distribution, protecting study blinding and preparing all import and export documentation.

Returns, final reconciliation, and destruction

We provide proper execution and compliance with local regulations in the critical processes of returns, final reconciliation and destruction.
Our services include:
• Protocol-specific set up;
• Reconciliation services for clinical site returns of investigational product, even documented by product pictures;
• Storage capacity post-reconciliation;
• Preparation of clinical trial material for destruction through a validated and certified incinerator;
• Certificates of destruction signed by EUQP;
• Full regulatory compliance and documentation support.

Certifications

Depo Pack - Autorizzazione_aAMM-35_2021-1

AUTORIZZAZIONE aAMM-35_2021
Depo Pack - GMP_IT-26-H-2021-1

CERTIFICATO GMP IT-26-H-2021
Depo Pack -

AUTORIZZAZIONE UCS 275/2021