Clinical Studies are today conducted only by specialized companies with complete know how to give real results. Blooming Impex is a large group of people sharing very good relations with Clinical practitioners and Hospital doctors across the country. We conduct countrywide clinical trials with specialty and with full support of large chain of doctors and also under CE regulations for the best acceptance. Our people work with marvelous experienced Doctors to bring best to your investment.
What we do for you
Finalizing Proposal with total cost quote
- Preparing Investigation Brochure/form
- Monitoring of clinical Trials
- Providing Lab services for conducting Clinical Studies:
– Clinical Chemistry
– Hematology
– ECG
– X ray (when relevant)
– Ethics committee submission
– 0Writing Clinical Trial Protocol
– Making all other Documents
Studies that in conduct
Our clinical studies are aimed at answering critical questions about diagnostic methods and identifying potential new therapeutic drugs or intervention.
Participating in clinical studies
Register for a Medical Trial
Have you ever thought of taking part in a Medical Trial? By registering your details with us, we put you in the list of volunteer to take part in their medical research studies. you will be contacted earliest at an opportunity. Information about you is kept confidential.
About clinical trials
A clinical study is study of how a new medicine or treatment works in people. Through clinical studies, doctors find new and better ways to prevent, detect, diagnose, control, and treat illnesses.
The aim of clinical trials is to determine if a treatment works and if it is safe. By comparing similar groups of people taking different treatments for the same disease it is possible to show whether any benefits are due to the treatment. Effective treatments identified in this way may then become standard practice. Since the research is experimental, those who take part in early studies may not always benefit.
Basic principles of a clinical trial
clinical Trial Research with patient is to be conducted according to strict scientific and ethic principles. Every clinical trial has a protocol that acts like a “Formula” for conducting the trial. The protocol describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. The protocol used at differen locations of clinical studies is same.
Including a Patient in to clinical trial is a process in which a patient is informed in details about the risks and other facts related to clinical Studies. The patient is then asked for a permission in form of a signed letter [included in protocol]. All the permission and explnantions are to be well documented as per protocol.
Various approvals are required to ensure the safety of Patients under study; These are to ensures that participants are treated humanely and ethically and with minimum Risk in comparison to treatment possibility wit a drug.
The Clinical Trials industry is heavily regulated and the standards of care that you will receive from doctors of reputable organizations participating in studies will be very high. They are specialised and willing to answer any questions that you have.
Phases of trials
Preclinical trials
early experiments performed in the lab before testing on Human. This is to identify medicines that are ineffective or are not safe for a clinical Trials (high Risk!).
Phase I :
first step of Trial on Human with very less number of Patient. here doctor determine
- amount of dose safe for patient & lethal dose.
- administration mode (i.v. oral, i.m., spray)
- frequency of administration to maintain or bring effect of drug under trial.
Phase II :
the safety and effectiveness of an agent or Medical intervention is studied, and effects are evaluated. Phase II studies usually focus on a particular medical condition.
Phase III:
Phase III trials compares a new drug or new use of a standard drug; with the current standard therapy. participating patients are randomly assigned group as per the drugs as standard group or the new group. Phase III trials may include large number of people across the country. The method is called randomization done to avoid bias and ensures that human choices or other factors do not affect the results
Trials can be randomized. Each participant in a randomized trial is assigned by chance (through a computer or a table of random numbers) to one of two groups:
The investigational group, made up of people who will receive the therapy, also called the active treatment.
The control group, made up of people who will receive either the standard treatment (if there is one) for their disease or condition, or a placebo. Each participant has an equal chance of being assigned to either group. In some complex trials, there are more than two groups. Randomization is used in all phase III studies and in some phase II studies. It gives the best chance of knowing that the study results are caused by the treatment and not some other factor, such as people’s choices or beliefs. Trials can be double-blind. This means that neither the researchers nor the participants know who has been assigned to which group. Blinding is another way to help minimize the chance of bias influencing the trial results. The information is kept on file at a central office, so if there is an urgent need for the research team to find out who was assigned the active treatment, they can.
Researchers design clinical trials to have one or more endpoints. An endpoint is a measure that determines whether the treatment under study has an effect. An example of an endpoint is whether a person’s tumor shrinks after receiving chemotherapy
Phase IV :
Phase IV is conducted to evaluate the long-term safety and effectivity of a treatment. they are conducted only if therapeutic affects of drugs are proven in earlier levels of study.
Types of studies conducted
Parallel Study:
A parallel clinical Study compares the results of a treatment on two separate groups of patients.
Crossover study:
A crossover clinical study compares the results of a two separate treatment on the same group of patients.
Major types of clinical trials as per end use of study:
- Treatment trials test: treatments for a specific disease or condition.
- Supportive care trials: also called quality-of-life trials, study ways of making sick people more comfortable and giving them a better quality of life.
- Prevention trials study ways to find the ways to reduce the chance that healthy people, but may be at risk for a disease, will develop the disease.
- Early detection or screening trials study new ways of finding diseases or conditions in people who are at risk, before they have any signs or symptoms.
- Diagnostic trials test new ways to identify, more accurately and earlier, whether people have diseases and conditions.