Meeting with local laboratory staff and conducting an effective audit in terms of the requirements of the study. Establishing an understanding of how local systems work and how these can be used to achieve the client’s requirements in terms of the study.
Reaching a contractual Service Agreement with each local lab including cost of analysis for study parameters and Data Harmonisation reference serum, timely results provision, access to QC and QA information procedures and provision of all relevant lab documentation to comply with regulatory requirements.
Hosting study set-up meetings with local investigator site staff and laboratory staff together, stipulating study specific service requirements, identifying potential problem areas and seeking agreement on how these can be solved including establishing a truly functional and reliable two-way communications system so that problems can be quickly identified and resolved.
Working closely with client or sponsor project management staff and CRAs. Establishing a clear understanding of services being provided by POOL including patient tracking, central lab reports, study progress reports, site management reports, rules for AE or SAE responses, exclusion reports, setting up remote access to study database.
Working closely with client or sponsor data managers to identify procedures for resolution of lab data queries, customised electronic data format selection and frequency of data extraction upload to study database.
Provision of courier management and tracking of referral samples as required.
Full archiving services, both paper and electronic, including audit trails for all local laboratory actions and central lab services.
