Clinical Supply Services
We are a leading supplier of specialist clinical supply chain services, covering drug product development and manufacturing services, complex clinical supplies packaging, clinical labelling, as well as clinical distribution services.
Sharp Clinical Services Ltd’s knowledgeable project management and operational teams, bring together years of unmatched production and management experience in clinical supply chains, all over the world.
All projects are compliant with the highest quality standards, covering good manufacturing practices (cGMP), good distribution practices, and all international regulatory requirements.
Thanks to our vast experience in managing local and global clinical supply chains, access to the world markets has become a whole lot easier for you – from clinical production, labelling and distribution, to comparator sourcing and EU qualified person (QP) audit and release services – we will safeguard your product as if it were our own. We are big enough to deliver your global project, while remaining small enough to care.
Experience and expertise in manufacture, comparator sourcing, packaging and assembly
With more than 20 years of expertise in manufacture, comparator sourcing, packaging and assembly (including design, randomisation and label printing), global distribution, QP services, IxRS and retrieval and destruction of investigational medicinal product (IMP), we are your preferred provider throughout the clinical trial life-cycle.
|MHRA licensed facility conforming to the EU clinical trials directive.|
Overview of Sharp Clinical Ltd’s services
- Clinical supply chain optimisation
- QP consultancy
- Project management
- Design engineering
- Kit/tooling design
- Primary/secondary packaging consultation
- Protocol review and breakdown
- Import/export consultation/assistance
- International shipping consultation
- Study design
- Drug forecasting
- Validation studies design
- Stability protocol creation
- R&D specifications
- Formulation selection
- Formula development consultation
Formulation Development and Manufacturing We aim to help our clients overcome development challenges, whilst minimising costs and accelerating time-to-market. This means reducing the likelihood of false starts and incompatibilities, to develop optimum formulation and processing conditions.
Analytical and Research Services Sharp’s analytical and research services evaluate the performance of formulations using various investigative testing procedures, enabling the foundation for future developments.
Stability Study Services Our stability testing provides evidence of whether the quality of drug substance/product, alters with time under the influence of various environmental conditions, such as temperature and relative humidity.
Clinical Manufacturing Services We will work with you to fully understand the requirements of your project to ensure successful delivery of your clinical programme. Sharp provides clinical manufacturing services that are tailored to your specific needs.
Over-Encapsulation and Placebo Manufacture We will over-encapsulate solid oral dosage forms, back-fill with a suitable excipient and manufacture a placebo to match. This enables your clinical study to be scientifically credible by maintaining the integrity of your double-blind clinical study design.
Clinical Label Design and Print Through the utilisation of multi-language labels and interactive response technologies (IVRS/IWRS), Sharp can create patient kits suitable for any patient in any region, without the need to commit stock to a specific market, based on forecasts which are subject to change.
Clinical Packaging and Labelling Our proactive project management team are focused on providing unique and cost-effective clinical packaging solutions for your investigational medicinal product (IMP).
Clinical Storage and Distribution We take pride in clinical storage and distribution, getting the correct product to the right place at the right time, whilst maintaining the highest level of quality.
EU Qualified Person Services Within the EU, it is necessary that all investigational and medicinal products manufactured or imported by organisations holding a MA IMP, must have a ‘qualified person’ to approve and release each batch of IMP for usage in clinical trials.
Interactive Response Technologies The fast path to go live: randomisation and drug management solutions that work for your trial.
Comparator Sourcing We use our established network of approved suppliers to ensure the most efficient and regulatory compliant supply chain for your study needs.
Insourcing The benefits of Sharp insourcing include trained resources deployed quickly, reduced investment in training, speed to productivity, lower attrition rates, elimination of co-employment risks/issues, higher degree of quality throughput, and full-time employees with benefits.
Returns and Destruction We proactively encourage our clients to plan ahead and include the outline plan for how returns, reconciliation and destruction will be managed during the set-up phase of their project.