TDL Trials Services
TDL Trials is run by an experienced and dedicated team, which operates to ICH GCP guidelines and principles and offers full project and data management support to clinical development programmes. We work with clients from the outset, assisting and offering advice on specimen integrity, logistics, and day-to-day communications.
TDL Trials Laboratory Manuals include visit test schedules, study-specific collection instructions using our bespoke collection kits and request forms, or bulk supplies as required, and details of our accreditations.
Using the wealth of services in all disciplines available from TDL’s main laboratory, we offer clients a 4-hour turnaround time for routine testing, 24 hours a day, 7 days a week, 365 days a year. Sample handling is independent of the main laboratory.
TDL Trials provides clients with a dedicated team for the management of each study, with assigned project managers acting as a central point of contact throughout the entire course of the study. They manage all study activity and communications between clients and TDL, ensuring that study specifications are met.
Throughout the study, the project managers take an active role in supporting the investigator sites to ensure any queries are resolved and stock levels of site kits are maintained; they also offer guidance on any laboratory issues. We are happy to provide assistance during the initial investigator meetings, which can be an ideal forum to address any queries or questions that site personnel may have.
TDL Trial’s data management services are provided by an experienced team of data coordinators in respect of 21 CFR part 11 industry guidelines. This team is responsible for the extraction, validation and transfer of electronic data to our clients’ requirements.
The team provide cost-effective, quality solutions to meet individual study requirements. For example, interim data visualisation outputs can be provided for on-going review of clinical safety data, as well as end-of-study data, formatted as required. The data can be in bespoke formats, programmed to exact client specifications, or ‘standard’ TDL outputs available in common data file types (such as SAS, Excel, ASCII, etc).
A full range of data-transfer options are available (including FTP, encrypted email, upload to secure portals etc.) to ensure that data are provided to the requirements of our clients.
Sample Management and Logistics Services
TDL Trials provide sample management, archiving, storage and shipping for clients. Samples can be stored for both long- and short- term periods at ambient, refrigerated or frozen temperatures, including liquid nitrogen storage.
We offer clients the option of bespoke courier logistics as part of the study service component. We ensure that any proposed shipping services provide clients with the option of supplies to ensure specimen integrity within shipping regulations. Depending on budgets and courier capabilities, TDL Trials will assist with the selection process based on our knowledge and expertise. Our service partners are qualified to handle temperature-controlled shipments and provide validated packaging.
TDL Collect operates its own dedicated and extensive courier network to ensure rapid and convenient sample collections throughout the world. Shipments can also be booked securely on-line at www.tdlcollect.com
TDL Postal Pathology
TDL Postal Pathology provides a cost-effective solution and is particularly suited for small single centre studies, patient monitoring and epidemiological studies.
All third-party companies are carefully selected by TDL based on their expertise in areas of biopharm logistics and services governed by IATA, ICAO, DfT and ADR regulations for transporting clinical specimens.
TDL Trials handles thousands of shipments (both medical supplies and biological sample) across the globe.