Industry Links and Resources

U.S. Food and Drug Association (FDA)

Office for Human Research Protections (OHRP)

U.S. Department of Health and Human Services OHRP Home Page http://www.hhs.gov/ohrp/

HIPAA

The HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information. The NIH information on Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule is a valuable resource as well, click here to view.

National Institutes of Health (NIH)

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency—making important discoveries that improve health and save lives.

Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings.

American Society for Quality (ASQ) is a professional association and a global community of experts and the leading authority on quality in all fields, organizations, and industries.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) makes recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines.

Drug Information Association (DIA) is a neutral, nonprofit, global professional association containing members who work in the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products.

The President’s Council on Bioethics advises the President on bioethical issues that may emerge from advances in biomedicine and related areas of science and technology.

Parental Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community.

Regulatory Affairs Professional Society (RAPS) is a global membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making.

The Society of Clinical Research Associates (SoCRA) is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals.

Society of Quality Assurance (SQA)  is a professional membership organization dedicated to promoting and advancing the principles and knowledge of quality assurance essential to human, animal and environmental health.

Indiana Life Science Associations:

BioCrossroads advances Indiana’s next generation of growth and innovation through its funding, launching new businesses or products, and partnering with our state’s research institutions, global companies, philanthropic organizations and government.

Indiana Biomedical Entreprenuer Network (IBEN) strives to enable entrepreneurship in life sciences and medicine throughout Indiana. This is achieved through social networking, education and events featuring experienced entrepreneurs.

Indiana Health Industry Forum (IHIF) unites the disparate sectors of an industry that has a collective impact on human health and health care. For the Indiana Health Industry Forum, these sectors include: medical device development and manufacturing, pharmaceutical and biotech development and manufacturing, service companies offering expertise to the sector, hospitals that interact with the business and clinical research communities, colleges and universities, payors, and health IT companies.

Indiana Medical Device Manufacturers Council is an association of medical device manufacturers and other companies that reflect a dedicated trade association and advocate for companies and individuals involved in the manufacture of medical devices.

INpact provides a dependable network of capable and proven product development resources and service providers. Meetings are held in Indianapolis, IN every third Friday of the month at 11am at Bingham and McHale.

For a list of more organizations for the field of Clinical Research, please visit our Resources page at our Pearl IRB site here.