Clinical Research
The scientific study that involves human participants to evaluate the safety and efficacy of medical interventions or to explore health-related issues.
What is clinical research?
Oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice.
What is the FDA?
They are responsible for the overall conduct and management of the clinical trial.
What is a PI?
The most common area in clinical trial research, representing nearly 50% of clinical trials worldwide.
What is oncology?
Profound's first market
What is Southern California?
They are responsible for reviewing and approving research protocols to protect the rights and welfare of human participants.
What is the Institutional Review Board (IRB)?
an organization contracted by another company to take the lead in managing that company's trials and complex medical testing responsibilities. They offer a wide range of services, including participant recruitment, data management, and safety monitoring.
What is a contract research organization?
Manages the day-to-day activities of a clinical trial, including participant recruitment, data collection, and study coordination.
What is a clinical research coordinator (CRC)?
Raleigh, Durham and Chapel Hill
OR
North Carolina State University, Duke University, and the University of North Carolina at Chapel Hill
What is the Research Triangle?
Profound will act as a site network and set up clinical trials sites within the walls of ____________.
What are research naive providers?
Unexpected changes or deviations from the original clinical trial plan.
What are protocol deviations?
BioNTech/Pfizer and Moderna COVID-19 vaccine
What is a sponsor?
One who has deep understanding of Good Clinical Practice (GCP) guidelines, regulatory requirements, and quality assurance processes specific to the pharmaceutical and biotechnology industry.
What is a head of quality?
a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.
What is the Belmont report?
Suvida is to Oxeon as Profound is to _____
What is Rubicon Founders?
1. Test a new treatment on humans, primarily its safety, dosage, and potential side effects.
2. Assess the treatment's effectiveness and further investigate its safety in a larger group of participants.
3. Compare the new treatment to existing standard treatments in a larger and more diverse population to confirm its efficacy and safety.
4. post-marketing surveillance to monitor long-term safety and effectiveness.
What are the 4 phases of clinical research and their purpose?
Accellacare is Icon PLC's ____ _____, they extend across the globe with 20+ active research sites and 55 affiliate sites in six countries with expertise in a wide range of therapeutic areas.
What is a site network?
_____ ______ are critical to the success of a clinical trial to ensure enough data can be collected to obtain meaningful results.
What are study participants?
studies that are supported by local or mobile healthcare providers that focus on bringing activities to patients instead of bringing patients to trial sites.
What are decentralized clinical trials (DCT)?
Our most recent Profound placement
What is Christopher Church?