WELCOME TO PROJECT pSMILE !

We are monitoring the impact of the COVID-19 coronavirus around the world. pSMILE is working with our NIH sponsor, clinical trials networks and other partners, and Johns Hopkins University to ensure that pSMILE's day to day operations are not adversely impacted. Please contact your pSMILE Coordinator or email us at [email protected] if you have questions or concerns.

We look forward to continued collaboration in promoting safety and quality in laboratory testing practices, providing assistance, guidance & training to clinical research laboratories, and being a leader in proficiency testing. We will continue to encourage and foster a sense of community among global clinical trials network laboratories while encouraging Integrity, Quality, Leadership, Support, Empowerment and Diversity over these upcoming seven years. Thank you to all who supported us during our recompetition. We could not accomplish the objectives of pSMILE without the support of our many collaborators!

pSMILE is a contractual resource at Johns Hopkins University designed to evaluate and develop the capability of laboratories to participate in the National Institutes of Health (NIH) - Division of AIDS (DAIDS) - supported prevention, vaccine and therapeutic clinical studies conducted in developing countries; and ensure the integrity and reliability of tests for monitoring safety and efficacy of experimental products investigated in DAIDS - supported studies in developing countries.

About Us

Our Vision

pSMILE aims to become a leader in innovative and customized approaches to quality assurance by delivering resources and support to global clinical research laboratories, enabling our partners to be forerunners in infectious disease research and community health administration.

Our Mission

pSMILE is dedicated to supporting the quality assurance efforts of worldwide clinical research laboratories in order to improve, advance, and empower local healthcare and disease prevention in developing countries.

Our Values

Integrity

We inspire laboratories to achieve excellence in international standards by promoting safe testing practices that produce reliable and valid results.

Quality

We ensure that global communities receive quality care by providing assistance, guidance and training in understanding international laboratory practice guidelines.

Leadership

We are leaders in proficiency testing, and partner with a worldwide network of community health and disease prevention clinicians who are also leaders.

Support

We train and assist laboratories in support of a broader shared mission of community health improvement and infectious disease prevention.

Empowerment

We foster a sense of community among a global network of laboratories, while promoting the independence and autonomy of each laboratory we work with.

Diversity

We are enriched by the efforts, talents and perspectives of diverse staff and partners.

Our Partners

Partner	Country	Site
National Institutes of Health (NIH) A part of the U.S. Department of Health and Human Services, NIH is the largest biomedical research agency in the world. NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.	USA	Website
National Institute of Allergy and Infectious Disease (NIAID) NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID is one of the 27 Institutes and Centers of the National Institutes of Health (NIH).	USA	Website
Division of Acquired Immunodeficiency Syndrome (DAIDS) The Division of AIDS (DAIDS) was formed in 1986 to develop and implement the national research agenda to address the HIV/AIDS epidemic. Toward that end, the division supports a global research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an "AIDS-Free Generation," the division develops and supports the infrastructure and biomedical research needed to: 1) halt the spread of HIV through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) partner with scientific and community stakeholders to efficiently implement effective interventions.	USA	Website
AIDS Clinical Trials Group (ACTG) The AIDS Clinical Trials Group (ACTG) was initially established in 1987 to broaden the scope of the AIDS research effort of the National Institute of Allergy and Infectious Diseases (NIAID). The ACTG established and supports the largest Network of expert clinical and translational investigators and therapeutic clinical trials units in the world, including sites in resource-limited countries. These investigators and units serve as the major resource for HIV/AIDS research, treatment, care, and training/education in their communities.	USA	Website
The College of American Pathologists (CAP) As the world's largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, read the CAP Annual Report at CAP.ORG.	USA	Website
FHI360 FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing - creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.	USA	Website
HIV/AIDS Network Coordination (HANC) The Office of HIV/AIDS Network Coordination (HANC) works with the HIV/AIDS clinical trials networks of the U.S. National Institutes of Health (NIH) with the intent of creating a more integrated, collaborative and flexible research structure. The networks are an affiliated group of national and international medical research institutions and investigators that conduct clinical HIV/AIDS research to develop safe and effective drugs, prevention strategies, and vaccines.	USA	Website
The HIV Prevention Trials Network (HPTN) The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection.	USA	Website
The HIV Vaccine Trials Network (HVTN) HIV Vaccine Trials Network (HVTN) - The HIV Vaccine Trials Network (HVTN) is the world's largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.	USA	Website
Immunology Quality Assessment (IQA) The mission of the IQA program, is to improve national/international standardization and overall performance of immunology laboratories participating in the National Institute of Allergy and Infectious Diseases Division of AIDS (NIAID) sponsored clinical trials and research programs. An additional component of the IQA is to help develop new technology and laboratory assays that may be useful in monitoring patients with HIV infection and evaluate potential HIV vaccines, as well as adding new insights into the pathogenesis of disease progression.	USA	Website
Immunology Quality Assessment (IQA) The mission of the IQA program, is to improve national/international standardization and overall performance of immunology laboratories participating in the National Institute of Allergy and Infectious Diseases Division of AIDS (NIAID) sponsored clinical trials and research programs. An additional component of the IQA is to help develop new technology and laboratory assays that may be useful in monitoring patients with HIV infection and evaluate potential HIV vaccines, as well as adding new insights into the pathogenesis of disease progression.	USA	Website
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a global collaboration of investigators, institutions, community representatives and other partners organized for the purpose of evaluating interventions to treat and prevent HIV infection and its consequences in infants, children, adolescents and pregnant/postpartum women through the conduct of high quality clinical trials.	USA	Website
INSTAND INSTAND e. V. is an interdisciplinary, not-for-profit, scientific medical society with over 300 members. It has been organising EQAs as part of external quality assurance in the area of haematology since 1968. In 1970, this service was extended to include nearly all areas of laboratory diagnostics.	USA	Website
Maine Standards Company Maine Standards Company's purpose is to improve the quality of human diagnostics. Established in 2001, Maine Standards Company specializes in calibration verification / linearity testing, serving clinical laboratories and most recently the physician office labs. With well over fifty years of experience, they consistently develop and manufacture products of the highest quality for calibration verification / linearity, reportable range validation and new instrument performance validation.	USA	Website
Microbicide Trials Network (MTN) Microbicide Trials Network - The MTN is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases, with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The MTN brings together international investigators and community and industry partners whose work is focused on the rigorous evaluation of promising microbicides - products applied inside the vagina or rectum to prevent the sexual transmission of HIV - and of dual-purpose products for preventing both HIV and unintended pregnancy.	USA	Website
MRIGlobal (TBQA Contract) MRIGlobal has been awarded a contract from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), to support its Mycobacterium tuberculosis (Mtb) Quality Assessment requirement (known as, TBQA). MRIGlobal will evaluate Mtb technologies and specimen processes to be used in NIAID-supported clinical investigations and disseminate TBQA technical and scientific data.	USA	Website
One World Accuracy (OWA) Oneworld Accuracy is a leading healthcare informatics company, headquartered in Vancouver, British Columbia, that specializes in the provision of Internet-enabled quality management systems that are used by medical laboratories and healthcare organizations to assess, monitor and improve the accuracy and reliability of their diagnostic test results.	Canada	Website
Pharmaceutical Product Development (PPD) PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.	Canada	Website
R&D Systems R&D Systems, a Minnesota-based biological products company, started by producing hematology controls and calibrators for use in hospitals and clinics. In 1977, we introduced our first product, a platelet-rich-plasma control, and in 1981, we became the second manufacturer in the world to release a whole blood control with platelets. Over the years, R&D Systems Hematology has continued to develop a variety of hematology controls. These products continue to be available through their Clinical Controls Division.	USA	Website
SmartSpot Quality SmartSpot Quality is a companion diagnostic for qualifying the accuracy of molecular TB diagnostic tests. SmartSpot has developed a patented technology that enables us to safely package inactivated Mycobacterium tuberculosis on a simple spot on a card which is easily and safely tested like a patient's clinical specimen.	USA	Website
UK NEQAS UK NEQAS aims to improve patient care through monitoring the quality of tests and their reporting, in an independent manner and on a not-for-profit basis. We are here to help ensure optimal quality in testing for the benefit of patients. We believe that the result of tests should be: Comparable, Safe, and Clinically useful to the patient no matter where or when they are performed.	United Kingdom	Website
U.S. Military HIV Research Program (MHRP) U.S. Military HIV Research Program - MHRP is at the forefront of the battle against HIV to protect U.S. troops from infection and to reduce global impact of the disease. With an international network of research sites throughout Africa and Asia, the program's growth and success has been achieved through a combination of strong science, careful development of research sites and partnerships with key research institutions in the U.S. and host countries.	USA	Website
Virology Quality Assurance Program (VQA) The Virology Quality Assurance Program, or VQA, is a contract of NIAID/NIH and is designed to provide virology quality assurance/quality control to NIH-supported laboratories conducting virologic assays on patient samples for clinical trials. The specific aims are to improve the scientific integrity of data generated by these collaborative studies with the use of innovative and state-of-the-art technology.	USA	Website