Pre-Clinical Contract Services, LLC (PCCS)

Mission:

Pre-Clinical Contract Services, LLC (PCCS) is a leading contract research organization that assists medical device, pharmaceutical, and biotechnology companies in conducting pre-clinical studies. Our mission is to provide accurate and reliable data from the safety, efficacy, and surgical studies on products intended for human and veterinary use at a reasonable cost.

Services:

Pre-Clinical Contract Services, LLC (PCCS) is a contract research organization that collaborates and partners with academic and private research institutions overseas (India and China) to provide pre-clinical testing services to medical device, pharmaceutical and biotechnology companies across the globe. PCCS is committed to offer world class testing services at highly competitive price. We offer a wide range of in vitro and in vivo test models for safety and efficacy assessment of drugs and medical devices. Our staff, consisting of study directors, veterinarians, scientists, and technicians is highly qualified, experienced and competent in tailoring existing test models, and developing new models in collaboration with sponsors to meet specific requirements. For a fast completion of studies we have on-site state-of-the-art laboratories that are fully equipped to meet all of your pre-clinical in vitro and in vivo testing needs.

In vivo Testing Services

We have animal models to evaluate the following:

• Safety and Efficacy of medical device
• Cardiovascular
• Urology
• Anesthesia/Respiratory
• Surgical
• Acute and chronic inflammation
• Drug toxicity
• Infectious diseases
• Dermatology

Some of the specialized animal models we have developed in the past include hemodialysis model (rabbit and sheep), and urinary model (rabbit, sheep and goat), both for studying catheter associated thrombus and infections. Our surgical suites are well equipped to support long term studies requiring ICU set-up; one such example is a dog model to study ventilator associated pneumonia due to long term endotracheal tube placement.

For timely completion of animal studies we have the following on-site laboratory services:

• Histopathology
• Hematology
• Biochemistry
• Physiology
• Microbiology

In vitro Testing Services

• Microbiology Tests for antibiotic/antimicrobial drugs
  • *MIC/MBC

    § Determination of the Minimum Inhibitory/Bactericidal Concentration of a drug

    o §MBEC

    § Determination of Minimum Bacterial Eradication Concentration (eradication of preformed biofilm)

    o ZOI

    § Zone of Inhibition

    o TTK

    § Time to Kill planktonic organisms, or Time to eradicate pre-formed biofilm

    o * FIC

    § Determination of Fractional Inhibitory Concentration

    § Test of a combination of two or more antimicrobial drugs

    *CLSI M7-A7

    §Modified from CLSI M7-A7

• Hemocompatibility Testing of blood contacting devices (ISO standard 10993)

  • Thrombosis

    o Coagulation

    o Platelet function

    o Hemolysis

• Cytoxicity Testing (ISO Standard 10993-5)

Please contact us to find how we can help move your device or drug along the development pathway.

Business Address:
1950 Butler Pike, #229
Conshohocken, PA 19428
USA
Phone: 484-269-1257
Fax: 610-630-8585
E-mail: vgupta@pcc-s.com
Website: www.pcc-s.com

Hemodialysis Machine				Mechanical Ventilator