Phase III Clinical Trials: Is It Better Than What’s Already Available?
The phase 2 to 3 transition has increasingly become a critical step in clinical drug development. This is the time in the life of a project when it will be…
Phase II clinical trials: Does the treatment work?
Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail…
Phase I Clinical Trials: Is The Treatment Safe?
The first step in testing an experimental drug (or other treatment) in humans. Clinical trials of medicines and biologicals typically proceed through 'phases' of development whereas clinical trials of medical…
Major Components and Definitions in Clinical Trials
Clinical trials aimed to improve health and quality of life are the cornerstone of progress in medicine. Support comes from academic medical centers, philanthropy, the National Institutes of Health (NIH),…
Roles and Responsibilities of Clinical Research Associate (CRA) During Clinical Trials
Clinical Research Associate also known as monitor is employed by either a pharmaceutical company or a contract research organization (CRO) which works on behalf of pharmaceutical companies. CRAs are responsible…
Sponsor Responsibilities Under Good Clinical Practice Guidelines
A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them. Any delegation of responsibilities to another party should be formally…
Primary Roles and Responsibilities of Institutional Ethics Committee (IEC/IRB) during Clinical Trials
In making decisions about health care, patients, families, and physicians and other health care professionals often face difficult, potentially life-changing situations. Such situations can raise ethically challenging questions about what…
Expand your Medical Device Regulatory Affairs Profession with British BioMedicine Institute NanoDegree Program
Medical Device Regulatory Affairs (MDRA) Specialists assist in obtaining and maintaining government approval for medical devices, nutritional products, and related materials. They are often employed by pharmaceutical, biotechnology, and medical…
Kick Start Your Principal Investigator (PI) Profession With British BioMedicine Institute NanoDegree Program
Being a Principal Investigator (PI) gives you the opportunity to develop a scientific vision and lead a team to transform that vision into knowledge. This means that you will be…
Unlock New Possibilities of Clinical Research Coordinator (CRC) Profession With British BioMedicine Institute NanoDegree Program
The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for…