GLP consultancy in general

The Kinesis consultancy services range from supporting a sponsor’s organization to improve the level of quality to managing the quality system. Depending on the needs of the organization Kinesis can identify problems by performing a GAP analysis, helping to solve those problems by supporting the sponsor’s Quality Assurance Unit, writing Standard Operating Procedures (SOPs), performing audits on studies or facilities and helping sponsors to obtain OECD GLP compliance. Kinesis can also assure independent auditing activities as performed by the sponsor’s Quality Assurance Unit. In addition, Kinesis can also help sponsors with the selection of Contract Research Organizations (CROs) or suppliers by performing audits. Kinesis has broad experience with computerized system validation and the coordination of multi-site studies with CROs located in different countries.

OECD GLP accreditation support

With its abundant knowledge and experienced multi-disciplinary team, Kinesis is actively involved in supporting Chinese CROs to acquire OECD GLP accreditation. Various activities are carried out for these Chinese CROs, such as establishing a standard in accordance with the international GLP non-clinical drug safety evaluation platform, focusing on the QA systems in all disciplines relevant for toxicological evaluation of compounds. The services that we offer include writing Standard Operating Procedures (SOPs), training personnel and providing support in writing study plans and reports. Kinesis performs on-site audits at CROs in China on a regular basis.