Clinical Trial Supplies

Our capabilities include contraced warehousing and distribution of investigational drugs and clinical supplies.

Our CTS Management services include:

• Procurement of import license
• Customs clearance of import shipment
• Management of local shipments to sites
• Storage of investigational product and other trial supplies
• Inventory management
• Coordination with local couriers
• Experience with IVRS

Medical affairs / pharmacovigilance

• Serious Adverse Event (SAE) Management
• Providing medical monitoring/support to sites
• Supporting the project manager in selection of investigators and sites

Regulatory affairs

• Collation, review and development of CT regulatory documents
• Translation and validation of relevant CT documents in local languages
• Submission to relevant ethics committees
• Regulatory application preparation
• SUSARs and ASURs timely submission 
• Continuous regional countries legislation review and update

Training

• GCP
• EU Directive
• Regional legislation
• Management and coordination of clinical trials
• Clinical monitoring
• Communication and presentation skills
• Principles, definitions and terminology of pharmacovigilance

We have experience in conducting CTs in the following indications:

• Oncology
• Neurology
• Respiratory diseases
• Allergology
• Metabolism
• Nephrology
• Andrology
• Cardiovascular diseases
• Haematology
• Immunology

For more information, please contact us.