Life Sciences & Research
Clinical trials, biotech research, and academic science run on precise, documented logistics. OnWay provides temperature-validated transport for investigational drugs, biospecimens, and research materials — with the regulatory documentation your IRB, FDA, and sponsors require.
Courier Services
Clinical Trial Supply Distribution
Site-to-site distribution of investigational medicinal products (IMPs), ancillary supplies, and protocol kits with temperature validation and GCP-compliant documentation.
Biospecimen Transport
Collection and transfer of blood, tissue, urine, and other biospecimens from clinical sites to central labs — with IATA P650-compliant packaging and cold chain validation.
Ultra-Low Temperature Transport
Validated −80°C transport for frozen biospecimens, cell therapies, and advanced biologics using dry ice and validated shippers with continuous temperature monitoring.
Investigational Device Logistics
Secure delivery of investigational medical devices and implants to clinical sites and research facilities — with tamper-evident packaging and signed chain of custody.
Regulatory-Compliant Documentation
All shipments include FDA 21 CFR Part 11-compatible electronic records — suitable for IND, BLA, and NDA submissions — with full audit trails available on demand.
Academic & CRO Research Logistics
Flexible courier support for academic medical centers and contract research organizations — from single-site pilot studies to complex multi-site Phase III trials.
Frequently Asked Questions
Can OnWay transport investigational drugs under GCP guidelines?
Yes. OnWay provides GCP-aware couriers and regulatory-compliant documentation for IMP transport. Our chain of custody records meet FDA 21 CFR Part 11 electronic record requirements and are suitable for IND applications.
What cold chain capabilities does OnWay offer for research materials?
OnWay supports ambient, refrigerated (2–8°C), frozen (−20°C), and ultra-low (−80°C) transport. Dry ice shippers are validated for multi-hour and multi-day transit, and continuous temperature data is available for every shipment.
Can OnWay support a multi-site Phase III clinical trial?
Yes. OnWay has experience supporting large multi-site trials with complex IMP distribution, return logistics, and biospecimen collection networks across multiple states.
Are OnWay drivers trained in IATA dangerous goods regulations?
Drivers assigned to biospecimen transport complete IATA Category B (P650) awareness training. For Category A infectious substances, we follow applicable DOT and IATA regulations with appropriate packaging and documentation.
How does OnWay handle unblinding or temperature excursion incidents?
OnWay has a documented incident response protocol. Any temperature excursion or shipment irregularity is immediately escalated to the client sponsor and documented in our audit trail — preserving data integrity for regulatory review.
Does OnWay work with CROs and academic research institutions?
Yes. OnWay partners with CROs, academic medical centers, biotech companies, and government research institutions — providing flexible logistics solutions tailored to each study's specific protocol and regulatory requirements.