United States of America:
Home to the Leading Global Mid-Sized CRO
- 25% of Staff in USA
- Global Headquarters: Houston, TX
- Staffed Office in Research Triangle Park
Additional Resources & Thought Leadership from Our USA Staff & Leadership Teams
The Gold Standard of Clinical Development
The measure of quality research worldwide.
- FDA sets the standards for rules & regulations. Adherence to GCP (Good Clinical Practices) sets the standard that most countries have adopted when it comes to clinical trials.
- The U.S. Food and Drug Administration (FDA) has evolved into one of the world's foremost institutional authorities for conducting and evaluating controlled clinical drug trials, requiring Sponsors to:
- Conduct all clinical study in accordance with the IRB approved protocol.
- Informing potential subjects that the drugs are being used for investigational purposes and reporting of adverse events that occur in the course of the investigation.
- Establish "Good Manufacturing Practices (GMP's)" to govern drug manufacturing.
But ample chronic disease state opportunity.
- Home to 39% of all recruiting sites worldwide (15,715)
- U.S. investigators enroll two-thirds as many subjects into clinical trials as investigators in the rest of the world. 27% of sites fail to enroll any subjects, compared with 19% of investigators elsewhere
- 90% of all clinical trials worldwide fail to enroll patients within the target amount of time and must extend their enrollment period
- Americans have high rates of cardiovascular disease, cancer and other chronic illnesses including inflammation, autoimmune and endocrine diseases
Clinical Trial Approval Process with a Focus on Safety
Study sites and researchers alike are held to the highest standards.
Throughout the approval process, we form a partnership with Sponsor companies, regulatory bodies and investigators to lead trials and facilitate communication with each other, so that issues such as safety are monitored closely. From start to finish, the approval process, on average, takes between 8 to 12 years.
Pharm-Olam has the services & solutions to assist development programs from Phase I through Post-Marketing.