Clinical Sample Handling and Kit Logistics Services
Clinical sample handling and kit logistics services aligned with client requirements for efficient bioanalytical programs integrated with bioanalysis laboratory services.
Intertek offers comprehensive clinical sample handling and kit logistics services that are crucial for maintaining the integrity of pharmaceutical samples. This process includes collecting, processing, packaging and shipping samples for our clients, providing support across an entire study and offering a fast and efficient path to market.
When submitting samples for analysis, certain protocols and methods must be followed to comply with regulatory standards. Pharmaceutical companies can find it challenging to ensure the proper procedures have been followed for collecting, packaging and shipping samples to the testing site. If the correct procedures are not implemented, samples may be compromised in transit resulting in a sample that can no longer be analyzed.
Our staff of dedicated, highly-trained professionals provide a customized approach and quality support services, with materials designed specifically for each clinical study. Through the development of study specific sampling manuals, sample collection kits, shipping kits and additional materials, we provide assurance that procedures are carried out in accordance with the study protocol, applicable regulations and validated methods.
Our services include:
- Quality support designed specifically for each clinical study and coordinated with our bioanalytical laboratory
- Specialization in domestic and international cold chain logistics for samples from multi-site studies
- Trained staff that develops everything from study specific sampling manuals to detailed labels to ensure that FDA/GLP/OECD regulatory compliance is met
- Exceptional quality at extremely competitive rates
- Integration with bioanalysis laboratory services
Sample Collection Laboratory Manual
The laboratory manual is specifically designed for each study protocol and includes all the instructions and documents required for notification, sampling, storage and shipment of samples from the collection site to the analytical site. The manual contains:
- Collection and processing of samples
- Storage requirements
- Sample shipment instructions
Robust and reliable packing and shipping materials ensure your samples will maintain appropriate conditions throughout transport. The materials included are:
- Shipping containers
- DOT required labels
- Packaging materials
- Coordination and delivery of dry-ice
- Coordination of shipping (both domestic and international)
- Access to preferred logistics carriers
Sample Collection Kits
Sample collection kits are designed for each client’s specific needs. Kits can be generic, patient specific, or interval specific. If a study requires a specialty collection tube containing additional additives or stabilizers, then these tubes can be included in the kits. All kits include:
- Sample collection tubes
- Storage cryovials
- Transfer pipettes
- Study specific labels
- Matrix collection sheets
Training and On-Call Support
Intertek provides staff training for sample handling and management, including the laboratory manual and kit preparation at each clinical site. If required, a 24-hour on-call service can also be provided at an additional hourly rate.
Intertek’s pharmaceutical labs are located around the globe, providing convenience and peace of mind to our clients. This worldwide reach provides total quality assurance for small, mid-size, and large pharmaceutical companies.