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
COVID-19 presented some unique challenges as we had to adjust to doing business in a virtual/digital world because of the new normal. Yet, the pandemic also gave us an opportunity to be innovative problem solvers, which is what we do best. Yet, to keep life-saving drug launches on track, we had to start doing virtual site audits for the first time—and discovered an excellent business model in the process.
Rich Nelson, Sr. Manager, Global Logistics, recently discussed the different aspects to importing clinical supplies into China including: the unique import requirements that China has, the benefits of running clinical trials in China, and moving clinical supply between Hong Kong and China.
PCI Pharma Services (PCI), a leading pharmaceutical and biopharmaceutical global outsourcing solutions provider, today announced a significant milestone in its global clinical footprint with the creation of a new Clinical Center of Excellence (COE) in Western Europe at its Berlin location, a major investment that will represent a new flagship site for customers. This is part of PCI’s global strategy to expand its clinical supply- chain network into continental Europe to complement offerings available at its UK and Ireland sites. The COE is expected to be completed in January 2021.
By its nature, EU compassionate use supply is needed urgently. This means packaging, labeling, and distribution must be executed rapidly and efficiently. Trial sponsors must know what issues to manage and need to select the transportation routes carefully, especially during COVID-19. Industry experts describe the logistical and distribution risk management factors that need to be considered when planning an EU Compassionate Use Program.
Extend the shelf-life of tablets and capsules with Activ-BlisterTM technologies. Activ-BlisterTM technologies is a novel technology that controls the moisture and oxygen in each blister pack. This exclusive technology is only available from Aptar CSP Technologies and PCI Clinical Trial Services.
Planning for cell and gene therapy trials requires an understanding of the product, control of unique supply chains, access to ultra cold-chain technologies, and global reach combined with local knowledge. Get an overview of PCI's storage and distribution capabilities for cell & gene therapies.
Rich Nelson, Sr. Manager, Global Logistics, recently discussed the precision with which clinical supplies and the documents accompanying their import into Japan must be prepared. In this article he covers the commercial invoice valuation of clinical kits, and clinical logistical considerations for Japan.
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.
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.
Regardless of whether you are a large or small sponsor, just-in-time labeling (JIT) can often be an effective option when packaging and distributing your drug products. Like all clinical supply chain initiatives, JIT comes with its benefits, but also has its challenges. This article will help you understand and overcome the challenges of just-in-time labeling so you can optimize the clinical packaging and labeling processes while simultaneously adding flexibility into the supply of drug product.
Distributing sensitive biopharmaceuticals and cell therapies is a complex challenge that calls for detailed understanding of the product, latest technologies, and a global reach.
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.
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.
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.
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.
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.
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.