One Protocol Deviation Can Cost Your Trial Months. We Make Sure It Doesn't Happen. GCP-Compliant Clinical Trial Logistics — IMP, Samples & Equipment, India & Global.
Investigational medicinal products. Patient biospecimens. Reference standards.
In a clinical trial, every item that moves is governed by protocol. A deviation at the logistics stage isn't just an operational problem — it's a regulatory event that can trigger a protocol amendment, a site audit, or an FDA query.
At BioMed Spedition, we build our clinical trial logistics services around the unique demands of GCP compliance. From IMP release at your depot to investigative site delivery, from patient sample collection to central lab receipt — every movement is documented, temperature-controlled, and audit-ready. We serve Sponsors, CROs, and SMOs running Phase I through Phase IV trials in India and across global markets.
GCP & GDP compliant. CDSCO regulatory expertise. Qualified cold chain for all IMP temperature profiles.
How We Protect Your Trial Materials
From Depot to Site to Lab.
Zero Protocol Deviations.
Our five-stage clinical trial protocol aligns with the requirements of GCP, GDP, and CDSCO Schedule M — so your logistics package is ready for any Sponsor or regulatory inspection from day one.
Cold Chain Solutions — IMP-Specific Configuration
-
Validated cold chain for every IMP temperature profile: cryogenic (−80°C) for biological IMPs; refrigerated (2–8°C) for vaccines and biologics; controlled room temperature (15–25°C) for small molecule IMPs. Packaging qualified per ICH Q1A stability data.
Scientifically Validated Clinical Packaging
-
GDP-aligned, validated packaging for IMP transport. Blinding preserved where required by protocol. Temperature data loggers (ELPRO / Sensitech / ryan) included in every shipment. Qualified packaging validation data maintained in our QMS for Sponsor inspection.
Regulatory-Compliant Transport & Import/Export
-
CDSCO import permits for investigational drugs. Dangerous goods documentation for Class 6.2 patient samples (IATA P650). Schedule M compliance for India-specific shipments. Customs clearance managed in-house — no third-party delays.
Chain of Custody Documentation
-
Complete GCP-compliant chain of custody from IMP release to investigative site receipt. Patient sample chain of identity maintained upstream. All documentation formatted to meet Sponsor QA requirements and ICH E6(R2) expectations.
Real-Time Monitoring & Deviation Management
-
GPS tracking and continuous temperature monitoring throughout transit. Automated alerts on parameter breaches. Proactive deviation management: if a temperature event occurs, you are notified immediately — with full data to inform your quality decision.
Every Material in Your Clinical Supply Chain. One Qualified Partner.
Investigational Medicinal Products (IMPs)
Small molecules, biologics, vaccines, and advanced therapy IMPs. Distributed to investigative sites with GDP-compliant cold chain, blinding preserved, and temperature records ready for your trial master file.
Patient Biological Samples
Blood, plasma, serum, urine, tissue biopsies, and CSF samples returning from clinical sites to central labs — IATA P650 compliant, time-definite, with chain of identity documented at every point.
Reference Standards & Comparators
Blinded or unblinded comparator products and reference standards — shipped with appropriate temperature control and tamper-evident packaging, maintaining blinding integrity per protocol.
Trial Equipment & Ancillary Supplies
Specimen collection kits, study-specific devices, cold chain equipment, and ancillary materials distributed to sites — coordinated with your site initiation timelines.
Why Sponsors and CROs Trust BioMed Spedition
Zero Protocol Deviations
Logistics-related deviations are a leading cause of trial delays. Our GCP-aligned processes, qualified packaging, and proactive monitoring are built around one goal: your trial stays on schedule and your data stays clean.
CDSCO & Regulatory Expertise
Navigating India's regulatory environment for clinical trial imports requires specialist knowledge. We manage CDSCO import licences, Schedule M compliance, and Form 40 documentation — so your team doesn't have to.
Inspection-Ready Documentation
Every shipment generates a complete documentation package: temperature data log, chain of custody record, proof of delivery — formatted for your Trial Master File and ready for FDA, EMA or CDSCO inspection.
Built for Every Role in the Clinical Trial Supply Chain
Sponsors (Pharma & Biotech)
Global IMP distribution, comparator sourcing logistics, and regulatory file-ready documentation for your clinical operations team. We act as a qualified supplier — ready for audit from day one.
Contract Research Organisations (CROs)
Multi-site, multi-country clinical supply chain management. We integrate with your CTMS and provide shipment status updates that map directly to site milestone tracking.
Investigative Sites & SMOs
Reliable IMP delivery on your activation schedule. Patient sample collection kits delivered ahead of visits. Emergency re-supply to site within 24 hours when stock runs low.
Central & Specialty Labs
Time-definite patient sample receipt from sites across India and globally. Sample integrity maintained from collection to analysis — with real-time tracking shared with your site coordinators.
A Logistics Deviation Doesn't Just Delay a Shipment.
It Can Delay an Entire Trial.
We know what's at stake in a clinical trial: years of investment, hundreds of patients, and a drug that could change how a disease is treated. A missed delivery window, a temperature excursion on an IMP shipment, or a customs hold on patient samples — these aren't just operational inconveniences. They can trigger protocol amendments, delay database lock, and push your submission timeline back by months. BioMed Spedition is built to make sure that never happens on our watch.