CLINICAL TRIALS

What we offer

Unilabs Serving Pharma services are delivered from GCP compliant and GLP certified laboratories. Our highly skilled and trained staff works in an organisation with more than 30 years’ experience in providing high quality and professional service to the pharmaceutical industry.

Unilabs Serving Pharma is our new drug development solution, building upon the expertise from Centres of Excellence in our laboratories in Denmark, Holland, Portugal, Sweden, Switzerland, and the United Kingdom. Our pharma services have supported both clinical and pre-clinical research during the past three decades, including clinical trials phases I-III, post-marketing follow-up studies, and analysis of pre-clinical study samples.

Unilabs Serving Pharma provides correct and timely data using robust and well-performing assays which are validated to comply with the current guidelines. Our high-quality laboratories and our dedicated teams of project managers, logistics managers, and scientific experts will provide guidance and innovative solutions to help your projects move forward and ensure their success.

Our services include:

• Central Laboratory Services
• Method development, transfer and validation
• Scientific expertise
• Good laboratory Practice (GLP), Good Clinical Practice (GCP), Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples and ISO/IEC 17025:2005 and 15189:2012
• Project Management
• Study-specific Laboratory Manuals and documents including information from external laboratories if applicable
• Study-specific sampling kits
• Logistics Management
• Dedicated support to Investigators, Study Monitors and Sponsors, responding to requests within 24 hours
• Esoteric Laboratory Testing (e.g. safety, PK/PD/efficacy parameters, biomarkers, ADA and molecular genetic testing.)
• Quality Assurance
• Data Management

If not all analytical tests are available on-site at Unilabs, we can handle the logistics of sample transfer to one of our partner-laboratories or to a laboratory of your choice. Unilabs Data Management services integrate laboratory data from external laboratories electronically into our Clinical LIMS system, providing transparent reporting of data in a consistent data file format.