Why Use Us?
Why go through us when you could go direct to a contract manufacturer? Simple – because MODEPHARMA’s streamlined approach for sourcing and organising medication for clinical trials saves time, money and hassle for the research team. Here are some reasons why…
Widest range of medication options
Working with a UK/European network of pharmaceutical industry experts and manufacturing facilities, MODEPHARMA provides comprehensive and unique services around the IMP. Click here for a list of our manufacturing and packaging capabilities. If we haven’t listed an option that you are interested in, contact us. It’s likely that we’ll be able to find the right solution for you.
Tailored to non-commercial trials and small/virtual pharmaceutical companies
Without the experience, organising the medication supply for a clinical trial can be a logistical nightmare. Our aim is to support non-commercial and small/virtual pharmaceutical companies fulfil their responsibilities as a sponsor. We do this by providing comprehensive project management and advisory services and we make the setup of a study simpler and more efficient. Our services are also particularly relevant for non-UK pharmaceutical organisations looking to initiate a clinical study in the UK.
Cost efficient and reliable
It is unrealistic to expect all researchers to possess insight into the broad range of pharmaceutical manufacturing possibilities out there. We help by using our commercial and IMP expertise to improve the quality of a trial whilst minimising budget outlay at the same time. Our quotes are all inclusive, easy to interpret and competitively priced. With no hidden costs, you can be assured that once you’ve signed on with us, we’ll keep to your budget.
Fulfils GMP and GCP requirements
All our projects are handled by our friendly and dynamic team of experienced Project Managers who are GCP certified and GMP trained. All manufacturing is carried out in accordance with the current EU Clinical Trial Directive 2001/20/EC and the European Commission principles and guidelines on Good Manufacturing Practices (Volume 4).
Annex 13 compliant label designs
Although, specific guidance regarding the labeling of IMPs is given in the European Commission principles and guidelines on Good Manufacturing Practices (Volume 4), it is all too often that certain details are missed. MODEPHARMA provides full assistance in designing of the label text or alternatively will act as a second check to ensure all the requirements have been met.
Fulfillment of required documents
Throughout a project, our Project Managers ensure document requirements – including the Technical Agreement, the quality data for the IMP dossier, CTA submissions (and amendments), batch records, stability reports, certificates of analysis and QP releases – are accurately completed for and distributed to both the contract giver and contract acceptor.
Advice on all aspects of IMP supply
Along with initial advice on production feasibility, we also assist in optimizing the design of the trial IMP by considering variables of the clinical trial (such as patient population factors) and also manufacture and stability dependent factors. Furthermore, we can advise on various manufacturing and packaging options to keep your project within its budget.
Budgeting assistance
Our team is happy to provide budgeting assistance during the trial design stages taking into account all factors such as the stability studies, number of batches required for the entire duration of the trial, and different packaging options.
Full project support & coordination
We know that managing medication for clinical trials is often complicated. MODEPHARMA provides comprehensive project management and advisory services making the co-ordination of IMP manufacturing and distribution a simpler, more streamlined process. With our team of project managers working with a 200 point checklist, researchers can carry out studies with minimal obstacles.
