ABOUT PCI CLINICAL SERVICES

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
  • IVRS-IWRS
  • Qualified Persons (QPs)
  • Support Services
  • Data Access

FEATURED PRODUCTS

Webflow™ Webflow™

Introducing Webflow™, the new PCI customer support app.

Compliance & Adherence Compliance & Adherence

PCI provides insightful and multifaceted solutions for addressing patient compliance and adherence for clinical investigational medicines as well as commercial applications.

Speed to Study Speed to Study

Accelerate your drug to proof of concept with PCI’s new Speed to Study™ services.

QP Services QP Services

Qualified Persons (QPs) play a vital role in bringing products, especially new products, to market within Europe. Global clients look to the diverse range of skills and specialisms of our highly experienced team of QPs to ensure their clinical studies not only meet the most rigorous standards but also run smoothly, seamlessly and cost effectively.

Analytical Services Analytical Services

PCI provides fully audited, in-house laboratories in both our European and North America locations offering a range of analytical services to support clients in the development and commercialization of new medicines.

Global Storage, Distribution & Returns Global Storage, Distribution & Returns

PCI offers the experience and insights of over 30 years in the storage and distribution of clinical trial materials, effectively storing and shipping thousands of patient kits to over 100 existing and emerging clinical trial countries across the world.

Clinical Trial Packaging & Labeling Clinical Trial Packaging & Labeling

With unrivaled experience in packaging and labeling, PCI combines knowledge, experience, and innovative technologies ensuring our ability to supply high quality products reliably and effectively wherever in the world our clients need them.

Clinical Manufacturing Clinical Manufacturing

PCI offers a broad range of services to address the manufacturing needs of our clients at each stage of the product lifecycle. Central to PCI’s international service offering is our capability to manufacture a range of dosage forms in compliance with current GMP standards.

Pharmaceutical Development Pharmaceutical Development

Our comprehensive service offering includes early stage formulation and analytical development, API capsule and vial filling using Xcelodose® technology, scale-up and stability testing, process validation, technology transfer and associated analytical support services.

Support Services Support Services

Rigorous attention to detail is paramount to the successful execution of global clinical trials.

Clinical Trial Supply Clinical Trial Supply

Pharmaceutical companies face continued pressure to develop and commercialize their medicines. PCI Clinical Services is committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively.

CONTACT INFORMATION

PCI Clinical Services

3001 Red Lion Road

Philadelphia, PA 19114

UNITED STATES

Phone: 779-774-1428

Contact: Becky Griffiths

FEATURED ARTICLES

  • Cold Chain Complexities Of Distributing Temperature-Sensitive  Biopharmaceuticals And Cell Therapies
    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
    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
    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
    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
    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
    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
    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.