Wellspring Clinical Services Specialist Clinical Services
Wellspring Clinical Services is a leading niche clinical services provider, backed with over 100 years’ experience in pharmaceutical logistics from parent company Mawdsleys.
Wellspring have worked hard to build strong relationships with drug manufacturers and develop global distribution networks, while adhering to strict MHRA guidelines on GDP. Add an unrivalled combination of clinical trial specialists, an in-house procurement team fluent in six languages, and an on-site team of global regulatory experts, and they are the ideal clinical trial partner.
Clinical trial regulations
Not only do they have a resident team of EU Qualified Persons, QP (IMPs), and relevant manufacturing and importation authorisations for investigational medicinal products (MIA IMPs), but with their experienced team, Wellspring can design a service to facilitate the smooth distribution of your clinical trial.
In line with GCP and GMP requirements, their experienced clinical labelling specialists can also design, generate and apply all the clinical trial labels you require, in whatever language you need, at a competitive cost and with a rapid turnaround time.
They can source even the most difficult to obtain comparators in single batch, packsize, quantities, or brands in multiple markets. They can provide reassurance on product safety and continuity of supply and take full responsibility for the logistics and QP release as well as guaranteeing complete confidentiality.
Placebos and encapsulation service
Wellspring can also provide you with high-quality placebo supplies and encapsulation services; they can also source all the comparators you need directly from around the globe. So whether you need one hundred placebos or one million comparators, the search ends with Wellspring.
Named patient program
Through parent company Mawdsleys, they can also work in partnership with manufacturers to help make products in clinical trial available on a named patient basis for patients who do not meet the clinical trial protocol. This helps manufacturers create access for their product pre-launch and satisfy advanced demand for the product. It is a key part of a pre-launch program, but it is time-consuming and difficult without a global pharmaceutical logistics network in place. Wellspring can develop a program that is fully compliant to global named patient regulations.
At Wellspring there is a dedicated team of biologists, GMP auditors and QP (IMP)s who can conduct a full audit of your manufacturing premises and, subject to a satisfactory outcome, release your biologic with QP declaration.
Whether your product is an advanced therapeutic product, combined advanced therapeutic product; whether it is a stem cell, tissue or a form of cell therapy, Wellspring has the knowledge and experience to help with QP (IMP) release into Europe.
They can also help with clinical trial applications or legal representation in Europe if needed, as well as creating a patient registry, which is a regulatory requirement in Europe when trialling a biologic, cell therapy, stem cell, advanced therapeutic medicinal product (ATMP), combined advanced medicinal product or medical device.
Biological audit – Vital Therapies
A team of biological specialists from Wellspring conducted an audit at the premises of Vital Therapies, the developers of a human liver cell-based device. Known as ELAD (extracorpeal liver assist device), the machine acts as an artificial liver taking over a person’s liver function for a few days or weeks to keep them alive until either a transplant becomes available, or the liver regenerates on its own.
The result was that Vital Therapies were then able to navigate the regulations concerning named patient basis and import the advanced therapy product into the UK at the request of a doctor.
Wellspring is currently coordinating the importation, shipping and logistics for the trial, which has already begun in the UK and will be rolled out to Denmark, Spain and France, and will involve over 80 patients.
Products and Services
Fujifilm Corporation and Merck, known as MSD outside the US and Canada, have announced that they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceutRead more
ACE Pharmaceuticals today announced that the first patient has entered the Phase III trial also known as the Levamisole trial. This trial was accepted by the EMEA by November 2006. The goal of this trial, which was accepted by the EMEA in November 2006, is to assess the efficacy and saRead more
ARTES announces the grant of the European patent on increasing recombinant protein secretion in yeast by co-expression of Calnexin, a protein responsible in intracellular quality control and sorting. In extensive studies, ARTES could show that overexpression of Calnexin results in signRead more
PROTEO Biotech AG and ARTES Biotechnology GmbH: Strategic Alliance for Marketing of Elafin in Asia, Africa and South America
Kiel - Erkrath, June 19, 2006. PROTEO Biotech AG, a wholly owned subsidiary of PROTEO Inc., USA, has signed a cooperation agreement with ARTES Biotechnology GmbH. The aim of the agreement is the marketing of Elafin, the lead product of PROTEO Biotech AG / PROTEO Inc., in India, Egypt and ArgentinRead more