ABOUT PCI CLINICAL SERVICES
Using our knowledge of pharmaceutical development, clinical manufacturing and packaging solutions, PCI provides unparalleled expertise and a seamlessly integrated drug development service delivering speed-to-market and commercial success for our client’s products.
From molecule to market, our innovative, leading-edge technology and continued investment in our people and facilities enables PCI to address global drug development needs at each stage of the product lifecycle.
Our global Clinical Trial Services include:
- Pharmaceutical Development Including Highly Potent Molecules
- Clinical Trial Manufacture Including Highly Potent Molecules
- Phase I aseptic processing
- Schedule 8 & 9 Phase I drug manufacturing
- Clinical Packaging and Packaging Design
- Primary Packaging
- Secondary Packaging
- Specialty Product Packaging
- Clinical Supplies Management
- Clinical Planning and Support
- Project Management
- Qualified Persons (QPs)
- Support Services
- Data Access
European Compassionate Use Programs: What Are The Quality And Distribution Considerations?
Compassionate use supplies in Europe are unlicensed medicines and not traditional clinical trial supply. As such the quality and distribution considerations are different for compassionate use supplies in Europe. This article discusses what factors need to be considered from a quality, packaging and labeling, logistical and risk management perspectives when planning an EU Compassionate Use Program.
Rapidly Switching To Direct-To-Patient Protocols
In the midst of the COVID-19 pandemic, clinical trial sponsors are having to quickly find alternative methods to keep their trials moving forward as challenges arise such as clinical sites having to close, or patients being unable to travel to the sites for safety reasons. This article discusses the factors which need to be considered for clinical trial sponsors to incorporate Direct-To-Patient (DTP) protocols rapidly, to help navigate the challenges presented by the COVID-19 pandemic.
Cold Chain Complexities Of Distributing Temperature-Sensitive Biopharmaceuticals And Cell Therapies
Distributing sensitive biopharmaceuticals and cell therapies is a complex challenge that calls for detailed understanding of the product, latest technologies, and a global reach.
EU GDP Guidelines: Implications For Shipping Clinical Materials Into The European Market
It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.
Making Clinical Trials More Effective By Keeping Focus On The Patient
The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and inconvenience patients. Today, priorities are changing as sponsors realize studies designed around the needs of patients also result in benefits to other stakeholders. This has led to the rise of patient-centric clinical trials.
Six Strategies To Stretch Your Limited Drug Supply For Clinical Studies
These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.
Successfully Managing The Unique Demands Of Cell Therapy Supply Chains
While cell therapy is playing an increasingly important role in the treatment of a variety of conditions, the real challenge in delivering it successfully is not necessarily in the manufacturing protocol alone, but in the administration and co-ordination of the complex supply chain as a whole. Therefore supply chain risk management (SCRM) becomes an essential part of the process. Risks associated with production and transportation need to be assessed in advance and formulated into a robust risk assessment strategy.
What Your Clinical Study Design Reveals About Your Clinical Packaging Needs
Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success. To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design.
ANNEX 13 Investigational Medicinal Products - Labeling Requirements Explained
Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance, and the QP or the site(s) rejected the materials you wanted to use in a trial? The purpose of this guide is to walk US-based clinical supply professionals through the labeling requirements laid out in Annex 13 of the EU GMP guidelines.