We provide Central Laboratory services in Clinical Trial protocols.
Our main advantages:
- Work in accordance with GCP, GCLP, ISO 15189 standards, readiness for audits and monitoring visits
- Professional team with many years of experience in Clinical Trials
- Organization of projects of any complexity, including logistics, laboratory kits, communication with Sites
- Wide diagnostic capabilities, willingness to implement non-standard laboratory research for the project
- Advanced Laboratory Information System (LIS) with extensive integration capabilities
- Personal Account for the Customer with a personal account and the ability to track tests results
- Preparation of project-specific database
- Storage of biomaterial at any temperature, including deep freezing in liquid nitrogen with automatic temperature monitoring with SMS notification
- Data protection, backup, data mirroring
- Individual approach to each protocol
Clinical trials are аny investigation in human subjects with the object of ascertaining safety and/or efficacy of the investigational product.
It is during clinical trials that the clinical and pharmacological effects of drugs are identified (or confirmed), adverse reactions to drugs are detected, the immunogenicity of vaccines is evaluated, and pharmacokinetics is studied.
The data obtained during clinical trials are necessary for further registration and market entry of newdrugs.
It is difficult to imagine a clinical trial without laboratory diagnostics. Laboratory parameters obtained in local and central laboratories may be important for the screening of study participants, for monitoring patient safety, for evaluating the effectiveness or immunogenicity of the drug.
The Aliquot Laboratory team has extensive experience in Clinical trials as a Central laboratory, as well as a laboratory of pharmacokinetics and immunogenicity.
We are ready to undertake aproject of anycomplexity, we can develop a research method for the project,verify or validate the chosen methodology in accordance with the applicable requirements of regulatory documentation.
Also, as part of the project, we are developing a set of documents in accordance with the requirements of GCLP - an analytical plan and laboratory manual, a guidance form, reference values and methodology; we can organize logistics, prepare protocol-specific laboratory kits for each visit with individual barcodes,communicate with Investigators for promptly clarification of the information and resolve queries on incoming samples, upload databases configured for your CRF, provide access to a personal account for each Investigational site, store primary documentation for 25 years.
We will be glad to receive new requests at info@aliquot.ru