Clinical Research

+1 (905) 564-5665

7035 Maxwell Rd

Mississauga, ON. L5S 1R5 Canada

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

Storage / Warehousing:

Our storage facilities are Health Canada and US FDA approved and following strict GMP guidelines. We are fully equipped to store all types of drugs, biologics, vaccines and investigational products under various temperature requirements. Our facilities are managed under very stringent quality conditions and our QA staff constantly monitors the temperatures of our warehouses, refrigerators and deep-freezers on an ongoing basis. We offer short-term and long-term storage solutions to fit the needs of our customers.

We can store products under the following managed environments:

Ambient: 15°C to 30°C
Refrigerated / Cold Chain: 2°C to 8°C
Frozen: -25°C to -10°C

Further, we offer the following to our customers in our self-managed and affiliate depot locations:

Validated Quality and Warehouse Management System
GMP, GDP, and Drug Supply Chain Security Act (DSCSA) compliant processes
Wholesale distribution licenses
DEA Class III – V, TSA and VAWD certification (for USA)
Designated areas for high value and/or controlled products; quarantined/high-level security storage

Shipping and Distribution:

Shipments of products, clinical trial kits, investigational products can be made under strict GDP and temperature controlled environments globally. Through our vast network of Depot locations, we can provide an end to end solution for all clinical trial related shipments.

We provide superior customer service with constant monitoring and daily updates with the shipment movement details
Abilities to handle and ship Hazardous Materials whether they are classified as deminimis or excepted quantities
Door-to-door service with full handling of customs and regulatory hurdles globally. Local partners ensure in budget and on time 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.

+1 (905) 564-5665

7035 Maxwell Rd