Smartway Clinical Trial Supplies (SCTS) is a dedicated business unit of Smartway Pharmaceuticals Limited, an established UK based company, which holds a Wholesale Distribution Authorisation (Human & Veterinary) issued by the MHRA, Controlled Drug Licence (Schedules 2-5) issued by the Home Office and an MS Licence which allows importation of products from outside the EU.
To guarantee our quality of operations, Smartway have Standard Operating Procedures (SOPs) in place alongside a registered Responsible Person (RP), a dedicated Clinical Trial supply team consisting of qualified Doctors, Pharmacists and Dentists and we provide a fully traceable recall procedure.
Using our dedicated Clinical Trial Supply team and our established relationships with manufacturers and with approved suppliers in the UK, EU, USA and Canada we are able to procure ethically and legitimately the necessary supply of comparator drugs, Reference Listed Drugs (RLDs), biosimilars and ancillary supplies without compromising the fundamental principles of careful handling, storage and distribution of drugs which are to be used in global clinical trials.
We are proud to declare that several pharmaceutical and biotech companies are amongst our regular and established clients. We retain their patronage, because at Smartway CTS, we offer an appropriate service customization package to suit all of our client’s needs.
At Smartway CTS we are aware that the requirement of every clinical trial is unique and we therefore endeavour to provide a reliable, cost-effective supply in appropriate quantities and time-frame. We will reduce your logistical and regulatory burden and thus improve the cost-effectiveness of your project with complete transparency and absolute discretion. We will not over-promise and under-deliver.
Where the collaborator or the sponsor of the clinical trial study is agreeable with us to disclose their Clinical Trial Authorisation Number (CTA) or the NCT number or the EUDRACT number we look to source directly from the manufacturer and to provide all of the associated documentation such as Certificate of Analysis (COA) and Certificate of Conformance (COC).
In instances where details of the Clinical Trial are to be kept confidential, we will endeavour to source directly from the manufacturer by providing relevant documentation. We are able to offer this service as a result of having a mutually trusting and established relationship with certain manufacturers.
For products that we are unable to source directly, we would look to source via our network of screened and vetted suppliers. These suppliers are regularly audited by our dedicated regulatory team to ensure that they are in compliance with current Good Distribution Practice.
We are able to offer but not limited to:
- Single batch supplies
- Multi country supplies of the same branded product
- Cold chain products
- Controlled drugs
- Unlicenced/specials products
- Investigational Medicinal Products (IMPs)
- Placebos in a variety of dosages and packaging forms
- Ancillary supply including medical devices