Is it necessary to conduct a clinical trial??
IT has been seen that the establishment if the CRO’s has been playing a prominent role in the discovery and development of new drugs in the department of medicine. The CRO’s are the organizations that take the overall responsibility of the clinical trials. This is a process that is conducted on the invention of new medicine, vaccine or drug. Below mentioned is the list of the functions of the Independent Auditors In Clinical Trials In India or in any other country of the world:
- Finding sponsors for the clinical trials: The process of clinical trials involves a lot of money for different phases and steps. For execution of this trial, several tools and machines are required. The contract research organizations help in finding the suitable sponsors for the treatment to be done efficiently.
- Ensuring the safety of the patients: The establishment of the contract research organizations has played a prominent role in ensuring the safety of the patients on whom the trial is to be conducted. This is the top most aim of the contract research organization. This is helpful in analyzing any kind of risks or threats on the patient before the clinical trial.
- Monitoring the data of the patient, so as to avoid any side effects: This is meant to monitor the data of the patient with the help of independent auditors for CRO after the conduction of the trial. The drug can give adverse reaction to the body of the patient, so it is must to carefully monitor his safety during the clinical trial.
- After completion of the pre-clinical treatment, the whole responsibility of the drug is taken into the formation of a new drug. This procedure starts with the acquired information.
- Approval or permission for the drug from the food and drug administration: After successful completion of the regulatory formalities, the execution of a clinical trial is done. The approval from the Food and drug administration or any other department can be obtained with the help of the contract research organization.
- Sending the drug in the market for selling, but keeping an eye on the adverse reaction on the patients, if any: The drug gets its existence in the market after completion of all the formalities successfully. An independent monitor for CRO keeps an eye of the effects of the drug on the customers after its use.
The appropriate functioning of the independent auditor in clinical trials helps in gaining beneficial results.
An independent monitor is selected by the sponsors of the clinical trial. This is done, so as to ensure proper governance around it. IT is essential to monitor a trial, as it is the moral duty for an individual to safeguard the life of a human being. Apart from this the arrangement of funds for the clinical trial is made by the monitor itself. This administrative support and the funding are provided by the government. These individuals must have to be up to date with the current regulations and protocols. This is because; they are responsible for carrying out a medical investigation. They are responsible for conducting site visits regularly.