Clinical Research-Working Areas

Working Areas 

      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 of trials:

      
Phase I
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 inform us 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.

    
Phase II

After the 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.

     
Phase III
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.

Phase IV
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 additional patients to 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- 

• Bioequivalence- 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.

• Biometrics- 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.

• Clinical operations- Clinical 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.

• Medical Writing- It includes 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.

• Pharmacovigilance- It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines so as to identify new information regarding hazards associated with medicines and thus prevent harm to patients.

• Quality assurance-  quality assurance ensures that client programs are conducted with the highest-quality project management and in strict compliance with industry guidelines

• Regulatory affairs- 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.

• Translations- Medical 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 clinic.