Clinical Research deals with the study of drug, biologic (a virus, therapeutic serum, toxin,
antitoxin, vaccine, blood, blood component or derivative, allergenic
product, or analogous product applicable to the prevention, treatment or
cure of diseases or injuries of man) or device in human subjects so as
to discover potential beneficial effects and/or determine its safety and
efficacy. So it deals with study of effects
(positive and negative) of new drugs/devices on human beings, via
studying Clinical, Pharmacological (pharmacodynamic and pharmacokinetic)
effects. Such type of service provider by Contract Research
Organization (CRO)-which may includes a person or an organization
(commercial, academic or other) contracted by the sponsor to perform one
or more of a sponsor's study-related duties and functions.
Means whenever a new drug is discovered it is not directly allowed for
production and prescription. The drug is first tested under four phases
This is the first stage of study where the new drug is administered to
small populations of pre-informed healthy volunteers under
the close supervision of doctors. This trial phase data
about the drug's toxicity, absorption, distribution and metabolism
give the indication whether the new compound is tolerated by the
patient’s body or not and if it is behaving in the predicted manner.
first phase of trial is O.K. the second phase of trials is conducted
where the drug is administered to around 100-300 group of pre-informed
patients (who are afflicted with the disease or condition for which the
drug was developed) so as to determine its
effect simultaneously to note down any unwanted side effects.
The third and last pre-approval round of testing of a drug is conducted
on large populations of afflicted patients
somewhere between 1000 and 5000.
Phase III studies test the new
drug in comparison with the standard therapy currently being used for
the disease in question.
The results are
statistically analyzed and if the results are found favourable, the data
is presented to the licensing authorities for a commercial license.
The information from results of these trials is included in the
package insert and labeling.
After the third phase of trials, company
starts manufacturing the drug and the medicine is made available to
doctors, who start prescribing it. Fourth phase of trial is a kind of
surveillance operation where the effects are monitored on thousands of
further study any adverse events.
Clinical research educational or training institute may include various
branches which are related to several operations in any clinical
research work like-
it is the comparision of generic drugs with brand name, before it is
sold in the market. The manufacturer has to prove that it has the same
strength and produce the same results, as the brand name medication or
affects people in the same way. If a generic drug passes these tests, it
is said to be bioequivalent to the original drug.
In biometrics a company draws meaning out of the enormous data that
comes out of clinical research, which can be demographics, disease
tracking or medicine management.
Operations is the key divisions of any clinical research organization.
It deals with conducting clinical trials “by the law of art“, that means
strictly according to the international standards in clinical research.
different types of work for clients in media,
government, and industry. Pharmaceutical companies, medical-device
manufacturers, and clinical-research organizations (CROs) all employ
writers to prepare regulatory documents used to seek approval for drugs
and medical devices. Medical writers also help doctors write research
articles, monographs, and reviews on medical topics.
is the science of collecting, monitoring, researching, assessing and
evaluating information from healthcare providers and patients on the
adverse effects of
medicines so as to identify new information regarding hazards
associated with medicines and thus prevent harm to patients.
ensures that client programs are conducted with the highest-quality
project management and in strict compliance with industry guidelines
In clinical trials, the department or function that is responsible for
ensuring compliance with government regulations and interacts with the
regulatory agencies. Each drug sponsor has a regulatory affairs
department that manages the entire drug approval process.
records/dictations by the physicians (or his/her secretary/nurse) and
other healthcare professionals regarding patient assessment, workup,
therapeutic procedures, clinical course, diagnosis, prognosis etc, into
a tape or onto a digital voice processing system are accurately and
swiftly transcribed, that is converted into a word document, by the
Medical translator (MT) or medical language specialist (MLS). These
records could be clinic notes, office notes, operative or consultation
notes, discharge summaries, etc. The documents are proofread to at least
98% accuracy before being “uploaded” back to the doctor’s office or