2. CLINICAL RESEARCH ASSOCIATE
Clinical Research Associate (CRA) works or is employed by pharmaceutical
companies or contract research organizations (CRO).
A CRA ensures that an adequate observation is carried out during clinical trials,
checks clinical site activities, makes on-site visits, reviews case report
forms(CRF), and then communicates with the clinical research coordinator.
A CRA will be involved in all stages of the clinical trial, including identifying an
investigation site and setting, initiating, monitoring, safety and side effects on
newly launched drugs, and closing the trial to a completion.
3. Roles & Responsibilities of a CRA in Clinical
Trials.
SPONSOR: Sponsors are responsible as appropriate to the set up of the clinical
trial. A sponsor is the device company that initiates a clinical trial for one of Its
products.
PRINCIPAL INVESTIGATOR (PI): The PI can be seen as the leader in the team. The
PI ensures that all the investigation and plans are followed according. And that
the right, safety, and well-being of the subject are maintained. The PI is
responsible for overseeing all parts of clinical trials, from start to finish in order to
assure variable results.
CO INVESTIGATOR (CO-I): The Co-I is almost similar to that of PI, but they focus
more on a specific aspect of clinical trials. They are often specialists in certain
fields, e.g., cardiologist.... they are tasked with overseeing the screening of the
subject, the implementation of protocol, the monitoring of the subject, and the
performance of administration and data collection activities.
4. Roles and Responsibilities of a CRA in Clinical
Trials contd.
REGULATORY COORDINATOR: The regulator ensures that the clinical trial is
ethical and legal. Their responsibilities are essential for ensuring the safety of the
subject for the duration of the clinical trial.
DATE COORDINATOR: They ensure the timely, reliable, and efficient compiling of
information gathered for the duration of the clinical trial.
OTHER RESEARCH PARTNERS: The department of regulatory agencies like Food
and Drug Administration (FDA), Health and Human Services (HHS), and other
regulatory agencies around the world play major role in clinical research. These
agencies regulate the conduct of clinical research in their countries. Maintaining
the enforcement of their regulations, covering research, and issuing guidelines
and procedures in research practice.
5. Discovery of marketable medicine is a long challenge process that takes up to 12-
15 years to approve the medication. Also requires a lot of investment for the
investigation to be carried out before making it available for patients to consume.
STEPS REQUIRED :
1. Research
Target identification and validation
Assay development
Lead identification
Lead optimization
Pre development
DRUG DISCOVERING PROCESS
6. DRUG DISCOVERING PROCESS
Contd
2. DEVELOPMENT
Preclinical development
Clinical research phases
3. REGISTRATION
Regulatory approval
Life Cycle management
7. PRECLINICAL TRIAL
Preclinical trials' purpose is to provide information on safety and the power to the product
to enable the conducting of clinical studies in humans. The information gathered from
preclinical studies provides the pharmaceutical company, the FDA ,and IRB quality
evidence before they make the decision about exposing humans to the compound.
