Bio-specimen Management
The proper handling, shipment and tracking of biological and pharmacokinetic samples plays a crucial role in many clinical trials. Our Bio-specimen Management professionals are experts in this field.
Our services include:
- Planning, organization and oversight related to the collection, processing and logistics of biomarker and pharmacokinetic samples
- Support of creation of a Biological and PK Sample Management Plan, lab manuals, sample handling sheets, etc.
- Support in the development of the sample logistics plan and the requirements for the collection of and storage of biological and PK samples in close cooperation with central labs and other vendors
- Oversight that biological and PK samples are taken and processed according to the clinical protocol, SOPs and ICH-GCP guideline
- Functional support in reviewing the suitability of investigational sites to collect, process and ship biological and PK samples
- Training of the study team and clinical sites regarding the collection and processing of biological and PK samples
