Our comprehensive services provide full management of the delivery of Investigational Medicinal Product (IMP) and any comparators you may require for your clinical trial.

Clinical trials are key to producing new innovative medicine: the benefits for patients are potentially life-changing; the rewards for pharmaceutical manufacturers, life-science and biotech companies as well as academic institutions, hospitals and any other contract research organisation, are potentially significant too. Yet they are expensive, complicated and challenging undertakings.

TRIAL PHASES

IPS Pharma participation in pre-clinical research and Phase 1 trial activity is limited. We do not currently manufacture new active pharmaceutical ingredient (API) molecules for use as an investigational medicinal product (IMP) when the pharmacodynamics, pharmacokinetics and unwanted pharmacological effects are being investigated.

The support services offered by IPS Pharma are most effective when used to support Phase 2 therapeutic exploratory trials, Phase 3 therapeutic confirmatory trials and Phase 4 post-marketing, label-claim extension clinical trials.

Global sourcing

With a trusted supplier network that spans the globe, we can efficiently and ethically source generics, biosimilar and other licensed medicines to act as comparators, samples, rescue medications and adjuvant drugs and Phase 2, 3 or 4 clinical trials.

Pharmaceutical manufacturing

We have a current Good Manufacturing Practice (cGMP) certified facility where we can hand-make one-off or very small batches of unlicensed medicines necessary to support a Phase 2, 3 or 4 clinical trial. Please be aware that we do not operate a sterile facility. For details of our manufacturing capability please click here ».

Blinding and over-encapsulation

To avoid the influence of bias in the results of a clinical trial, it is important that the test is single or double-blind. This means that the participant and, if possible, the trial’s principal investigator do not know which doses contain the IMP and which are a placebo or comparator. They might be different colours, or even different presentations. For the test to be blind, every dose needs to look the same and we achieve this by manually enclosing every dose in an identical capsule – over encapsulating.

Labelling

When labeling all the medication necessary for a clinical trial, we can include whatever information is necessary: trial name; principal investigator; dosage and administration details and the subject number. Critically, for double-blind testing, we can incorporate the randomisation supplied by the trial administrator, so that each subject receives their correct allocation of IMP or comparator for the duration of the trial.

Primary and secondary packaging

During a clinical trial, we can accept bulk delivery of IMP or comparators, simplifying logistics and significantly reducing transport costs, and undertake non-sterile repackaging prior to distribution to participants.

We have the in-house capability to transfer capsules, tablets and powders to primary packaging such as tamper evident amber glass and HTPE containers. If necessary, we can also insert primary packaging into appropriate card secondary packaging.

Distribution, shipment and delivery

From a simple on-time shipment to a single UK location to the complicated logistics of coordinating supplies from different sources and expediting delivery to multiple sites around the globe, our experienced team and proven network are available to help your trial run as efficiently and cost-effectively as possible.

QP services and technical consultancy

We can provide the full range of Qualified Person (QP) services to support a clinical trial. All our QPs are experienced licensed pharmacists who have earned the highest credentials in accordance with relevant standards and requirements. They provide legally responsible oversight for all matters of compliance such as: the import and export of medicines; process reviews or facility audits, quality management and adherence to cGMP etc. They can certify products for use in clinical trials and, once licensed, for release to market.

Our team possesses a wealth of experience in the clinical trial arena providing expert technical consultancy that can be brought to bear on the design and implementation of a cost efficient and effective clinical trial – making sure all operations, processes and procedures are compliant with all relevant directives and regulations and meeting any technical challenges that might arise.

CTA/IMPD review and advice

All clinical trials need a Clinical Trial Agreement (CTA) as well as an Investigational Medicinal Product Dossier (IMPD). We can review existing documents to make sure they are all in order and provide extremely experienced guidance and feedback on any improvements or amendments that we think are necessary. We can also author content covering our areas of responsibility, if IPS Pharma is playing an active part in the trial.

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Special Obtains

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Unlicensed Medicines (Specials)