Clinical Research
Introduction
Septa’s R&D sourcing and supplies division focuses providing services for Clinical Research and distribution of pharmaceutical products. Through our global product sourcing network coupled with secondary packaging abilities, we are a one-stop-shop for global clinical supplies. We also partner with hospitals, doctors and patients to provide access to unlicensed medicines or manage drug shortages including Managed Access, Early Access and Global Access programs.
For Doctors / Patients
We help patients and doctors to obtain early access to products that have yet to be launched in their country or products that are in shortage (Special Access Scheme and Exceptional Import Permission). These products can range from varying product-developmental stages i.e. Pre-approval clinical trial medicines currently or Post approval unlicensed products. We provide access to drugs, therapies and treatments for rare diseases, oncology and orphan drugs.
For Innovators
We work with trial sponsors to provide clinical trial material supplies. We help navigate critical and complex requirements for clinical trials such as stringent regulatory environments, sourcing hurdles and confidential trial protocols. We also understand that time is of the essence for Clinical Trials and hence provide an unparalleled access to comparators and RLDs globally without supply disruptions.
For Hospitals
Globally, Hospitals face product shortages daily for life saving drugs. We provide access to essential drugs to hospitals that are either commercially unavailable due to drug shortages or are currently unlicensed and unmarketed. Our strong, stringent and keen focus on quality ensures that authentic products are sourced and supplied directly to hospitals and speciality clinics quickly and efficiently.
Clinical Trials Sourcing
End to End supply and sourcing strategy to ensure lowest cost of product for the duration of the trial
Product sourcing through our well established network of relationships with Pharmaceutical Manufacturers, Distributors and Wholesalers
Ability to source multiple batches, single batches, short and long expiry as needed
Provide proof of Authenticity, COA, MSDS, T3 Documents and Pedigree Statements
Sourcing from multiple countries on an ongoing basis
Clinical Trials Storage and Distribution
Comprehensive clinical trial logistics are delivered through Health Canada and US FDA-approved facilities, adhering to strict GMP and GDP guidelines. Storage capabilities include validated warehousing for ambient, refrigerated, and frozen investigational products, alongside specialized handling for high-value and DEA Class III–V controlled substances. This end-to-end service extends to global distribution, featuring continuous cold-chain monitoring, hazardous material management, and full oversight of customs and regulatory clearance to ensure secure, door-to-door delivery.
Returns Management and Destruction
Simplified solutions for returns management for excess products, expired products and end of trial products. We provide a full trace of returns for compliance and recordkeeping in alignment with our customer requirements.
We manage all product dispositions i.e. return to vendor, return to R&D and disposition to comply with local and global pharmaceutical regulatory compliance. We provide full history and destruction certificates for all products in question.
Our experienced and knowledgeable team of Clinical Trial Sourcing Specialists can customize our offerings and/or package them to provide a price advantage based on your unique needs i.e. only comparator / RLD sourcing or full suite of services that include warehousing, distribution and returns management and product destruction. Contact us today to discuss your requirements.
