ABOUT SHARP CLINICAL SERVICES

Sharp Clinical offers a full complement of clinical trial services, including analytical, formulation development, clinical manufacturing and packaging, storage and distribution. Sharp also offers an interactive response technology (IRT) platform which can accommodate simple to complex randomization schemes as well as clinical supply chain management.

During 2018, Sharp Clinical invested $36 million in new dedicated facilities in both the US and the UK and can offer QP services for European distribution. We service every phase of the drug lifecycle from Phase 1 through to commercialization and through our global network of over 30 depots we can distribute to every region of the world. Our highly experienced team will help you optimize every aspect of your clinical trial.

CLINICAL SERVICES

Analytical And Clinical Research Services Analytical And Clinical Research Services

Our analytical and research services evaluate the performance of formulations using a whole range of advanced investigative testing procedures. They’re a hugely important part of our work, forming a valuable foundation for future developments and innovations.

Clinical Formulation Development Clinical Formulation Development

At Sharp, we’re here to help you overcome development challenges, keep costs down and accelerate your time to market. We’ll work with you to develop a reliable formulation that gives optimal clinical outcomes and can be easily reproduced on a large scale, with excellent stability.

Clinical IRT Services Clinical IRT Services

Increasingly elaborate international clinical trials demand a smart, streamlined approach and at Sharp we use interactive response technologies (IRT) to provide just that. They’re a powerful, practical tool for accelerating your product’s progress to launch and making the management of your trial much easier for everyone.

Clinical Manufacturing Services Clinical Manufacturing Services

At Sharp, we work closely with you to build an in-depth understanding of your goals, challenges and requirements before we begin our state-of-the-art manufacturing process. This enables us to tailor our clinical manufacturing services to meet your specific needs, making sure we deliver your product on time, to your exact specification, and all ready for a successful launch.

Clinical Over-Encapsulation Services Clinical Over-Encapsulation Services

Whether you’re looking for a placebo to match your product or designing your trial dose to match an existing comparator, getting a good match can be almost impossible. That’s where we come in.

We can over-encapsulate solid oral dosage forms like tablets or capsules, backfill them with a suitable excipient and manufacture a placebo to match. This gives real scientific credibility to your clinical trial, maintaining the integrity of your double-blind study design.

Clinical Packaging And Labeling Clinical Packaging And Labeling

At Sharp, we know that clinical studies are growing in complexity, with new geographic regions being introduced and fresh pressures on schedules, budgets and controls. That’s why our clinical packaging team does so much more than simply putting tablets in bottles.

Comparator Sourcing Comparator Sourcing

As the cost and complexity of global clinical studies increases and the number of biosimilar (or biogenetic) studies continue to rise, the availability of comparator products can make or break your clinical trial’s supply chain.

EU Qualified Person EU Qualified Person

It is a requirement within the EU that all investigational and medicinal products manufactured or imported by organisations holding a MA IMP, have a Qualified Person (QP) to approve and release each batch of IMP for usage in clinical trials.

At Sharp we offer well-established QP services, helping to streamline your product’s journey to trial and market in the EU, as well as giving you and your customers the confidence that your products have been manufactured to the very highest standards.

Clinical Packaging Services: Kitting & Design Clinical Packaging Services: Kitting & Design

Sharp can offer a wide range of solutions for your secondary packaging and kitting requirements. We offer labelling, boxing and tray packaging solutions for most pharmaceutical dosage forms including solids, semi-solids, liquids, inhalables, injectables and transdermal systems as well.  We also offer capacities for re-labelling and re-packaging activities.

Clinical Storage And Distribution Services Clinical Storage And Distribution Services

It’s the final interface between good manufacturing practice and the world of good clinical practice, but the importance of clinical storage and distribution is all too often overlooked.

CONTACT INFORMATION

Sharp Clinical Services

2400 Baglyos Circle

Bethlehem, PA 18020

UNITED STATES

Phone: 484-896-8545

Contact: Joe Scollins

Sharp Clinical UK
Unit 28, Heol Klockner
Heads of the Valleys Ind Est
Rhymney, NP22 5RL
United Kingdom
Phone: +44-7525-839-463
Contact: Scott Forde

WEBINARS

FEATURED ARTICLES

  • The Essential Role Of Interactive Response Technology (IRT) In Clinical Trial Supply
    The Essential Role Of Interactive Response Technology (IRT) In Clinical Trial Supply

    IRT professionals can bring together supply chain and clinical team staff for discussions on actual trial needs. Learn how including IRT professionals earlier in the planning phase of clinical trials may result in a better understanding of supply chain needs. This can increase the efficiency of inventory management and lead to unforeseen cost savings over the course of the trial.

  • The Sharp Story – Our Capabilities And Experience
    The Sharp Story – Our Capabilities And Experience

    Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. In this video to learn why Sharp Packaging Services has an exceptional global reputation for the design, serialization and production of innovative, cost-effective compliance packaging for even the most complex products.

  • Ingenuity In Clinical Manufacturing Reduces Duration And Complexity For Phase III Trial
    Ingenuity In Clinical Manufacturing Reduces Duration And Complexity For Phase III Trial

    Sharp Clinical Services provided a solution for a pharma clients that required a new oral formulation of their product. Multiple active ingredients created a complex manufacturing process combined with a requirements of 8 different batches required expertise of Sharp's Analytical and Formulation Development teams.

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