The role of patients in the clinical trial process has evolved significantly over time. In 1988, the Office of AIDS Coordination was established at the FDA, marking one of the first collaborations with patient advocates. Later, in 1993, the FDA welcomed patients as active participants in advisory committee meetings. While patients were once seen as subjects, they have now shifted into becoming partners with the FDA to assist with the drug development process. Want to learn more? The full article can be found here: https://lnkd.in/eS-276_d
Technical Resources International, Inc.
Pharmaceutical Manufacturing
Bethesda, MD 9,030 followers
About us
Founded in 1979, Technical Resources International, Incorporated (TRI) is a certified Hispanic woman-owned full service contract research organization plus (CRO+). We provide product development support services to the global drug, biologic, vaccine, medical device, and health sector communities through the effective combination of scientific, clinical, information technology, and communication services. For more than three decades, TRI has provided high quality services to clinical trial sponsors in the public and private sector. TRI’s success is based on the competence of our staff denoted by their qualifications and experience; and on the high level of client satisfaction as evidenced by the number of repeat business. We possess the customer focus of a mid-sized company, the adaptability of a seasoned contractor, and the global footprint of a large CRO. Headquartered in Bethesda, MD, TRI has been ranked among the fastest growing privately-owned companies in the U.S. under the Inc.500 | 5000 and in the top 500 Diversity-owned companies in the U.S. by Diversity Business.
- Website
-
http://www.tech-res.com
External link for Technical Resources International, Inc.
- Industry
- Pharmaceutical Manufacturing
- Company size
- 201-500 employees
- Headquarters
- Bethesda, MD
- Type
- Privately Held
- Founded
- 1979
- Specialties
- Adaptive Trial Design and Management, Biostatistics, Clinical Data Management, Clinical Monitoring, Communications, IND & NDA, Infectious Diseases, IT, Oncology, Product/Program/Protocol Development, Randomization, Regulatory Strategy, and Site Selection & Start-up
Locations
-
Primary
Get directions
6500 Rock Spring Dr. Suite 650
Bethesda, MD 20817, US
Employees at Technical Resources International, Inc.
Updates
-
The FDA recognizes the increased use of Artificial Intelligence/Machine Learning (AI/ML) throughout the drug development life cycle and its potential to expedite the development of safe and effective drugs. Over the last few years, there has been rapid growth in the number of regulatory submissions to the FDA that have used AI/ML components. Want to learn more? The full article can be found here: https://lnkd.in/ebxJEkVV
-
There is currently no internationally accepted, harmonized guidance or template for the format and content of clinical trial protocols. As a result, inconsistencies in content and structure among clinical protocols submitted to regulatory agencies complicate the review process, extend review timelines, increase the need for protocol amendments, delay study activations, and ultimately slow down drug development and patient access to new treatments. To address these difficulties, the International Council for Harmonisation (ICH) is developing a new harmonized guideline for clinical protocols, the Clinical electronic Structured Harmonised Protocol (CeSHarP), also called ICH M11. Want to learn more? The full article can be found here: https://lnkd.in/eUAW_q8Z