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.

Clinical services

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.

Comparator supplies

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.

Biological services

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.

Make an enquiry

Follow this company

Follow the company to be always up to date with this company

Press Release

Comparator Supplies – A Trial you Could do Without?

Sourcing comparator drugs is easy with the right partner. Wellspring, through parent company Mawdsleys, has worked hard to build strong relationships with drug manufacturers and develop global distribution networks. Add to this an unrivalled combination of clinical trial specialists, a dedicated

Address
Wellspring Clinical Services

Unit 4 Crompton Road Business Park

Crompton Road

Doncaster

DN2 4PW

Other

United Kingdom

+44 1302 553020 +44 1302 553013 www.mawdsleys.co.uk www.wellspringclinical.co.uk

Wellspring Clinical Services Images

Products and Services

Video

White Papers

Related Projects



Steglatro (ertugliflozin) for the Treatment of Type 2 Diabetes



Steglatro™ (ertugliflozin) is a combination drug indicated for the improvement of glycaemic control in adult patients with Type 2 diabetes mellitus.

2 April 2018

Zinbryta (daclizumab) for the Treatment of Multiple Sclerosis



Zinbryta (daclizumab) is an injectable formulation jointly developed by Biogen and Abbive for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

22 March 2018

Symdeko (tezacaftor/ivacaftor and ivacaftor) for the Treatment of Cystic Fibrosis



Symdeko™ (tezacaftor/ivacaftor and ivacaftor) is a combination drug indicated for the treatment  of cystic fibrosis (CF) in people aged 12 years and above.

20 March 2018

Lutathera (lutetium Lu 177 dotatate) for the Treatment of Gastroenteropancreatic Neuroendocrine Tumours



Lutathera® (lutetium Lu 177 dotatate) is a peptide receptor radionuclide therapy (PRRT) indicated for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

5 February 2018

Luxturna (voretigene neparvovec) for the Treatment of Biallelic RPE65 Mutation-Associated Retinal Dystrophy



LuxturnaTM (voretigene neparvovec) is approved for the treatment of patients with biallelic RPE65 mutation-associated retinal dystrophy.

5 January 2018

Bevyxxa (betrixaban) for the Treatment of Venous Thromboembolism (VTE) in Adults



Bevyxxa (betrixaban) is a drug developed by Portola Pharmaceuticals that is indicated for the prevention and treatment of venous thromboembolism (VTE) in adults.

2 January 2018

Admelog (insulin lispro) for the Treatment of Type 1 and Type 2 Diabetes



Admelog® (insulin lispro) is a rapid-acting human insulin analogue approved as a follow-on product to treat type 1 and type 2 diabetes in adults and paediatric patients aged three years and older.

20 December 2017

Nerlynx (neratinib) for the Treatment of Breast Cancer



Nerlynx™ (neratinib) is a tyrosine kinase inhibitor indicated for the treatment of adult patients with early-stage HER2-overexpressed or amplified breast cancer.

23 August 2017

Idhifa (enasidenib) for the Treatment of Acute Myeloid Leukaemia (AML)



Idhifa (enasidenib) is an isocitrate dehydrogenase 2 (IDH2) enzyme inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML).

17 August 2017

Imfinzi (durvalumab) for the Treatment of Metastatic Urothelial Carcinoma (mUC)



Imfinzi™ (durvalumab) is a monoclonal antibody (mAb) indicated for the treatment of metastatic urothelial carcinoma (mUC).

7 May 2017

Press Release

24 October 2010

Sourcing comparator drugs is easy with the right partner. Wellspring, through parent company Mawdsleys, has worked hard to build strong relationships with drug manufacturers and develop global distribution networks. Add to this an unrivalled combination of clinical trial specialists, a dedicated

Read more
18 October 2010

Wellspring's parent company, Mawdsleys, has recently acquired Luto Research to build upon its existing expertise in clinical trial services. Luto specialises in developing, enhancing and testing communications to patients and healthcare professionals, and will naturally complement Mawdsleys' clin

Read more
18 October 2010

Mawdsleys' clinical trials division, Wellspring, has further developed contacts in the international market, as they recently attended Bangalore Bio, India's premier biotechnology event. Nick Hill, Mawdsleys' unlicensed medicines manager, and a team from the clinical trials division par

Read more
11 May 2010

A remarkable new device for the treatment of liver disease is now one step nearer to being available in the UK and Europe, thanks to a unique collaboration between Wellspring Clinical Services and San Diego-based company Vital Therapies, the developers of a human liver cell-based device. <

Read more

Regional Offices

Wellspring Clinical Services

Unit 4 Crompton Road Business Park

Crompton Road

Doncaster

DN2 4PW

Other

United Kingdom

Steve Garner QP (IMP) +44 1302 553020 +44 1302 553013 www.mawdsleys.co.uk www.wellspringclinical.co.uk

Contact company

I have read and accept the terms and conditions and privacy policy.
We'd like to keep you informed about relevant promotions, products and services, if you would like not to receive these, check this box.
If you would like to hear from carefully selected third party companies, check this box
Follow this company to receive notifications when they update.