Faq’s

A BA/BE is a research study utilizing human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health. These studies play a key role in developing potential new drugs, vaccines, and medical devices.

Choosing to be a part of clinical study is a big decision, however your participation is completely voluntary. Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. It is no exaggeration to say that a large share of the credit for current treatment successes belongs to the people who participated in the studies conducted over the last decade. The role of volunteers in a study is critical in helping us answer questions and build the scientific basis that will improve the health of future generations.

All studies conducted by Amaris are regulated by the DCGI, F.D.A and comply with G.C.P regulations. We take all measures to protect the safety and rights of volunteer subjects. The studies are conducted by qualified physicians and other experienced medical staffs in a controlled environment to ensure necessary safety to our volunteers. All of the information necessary to assist you in determining whether or not to participate in a clinical trial is provided in a document called the "informed consent document." This document informs you of how to let the physicians know if you think you are experiencing a problem with the research and what resources are available to help you. You should ask any questions you may have about a study before signing the informed consent document. Even after you have signed the informed consent document to participate in a clinical study, you should always speak to the staffs if you have questions or problems.

You will have to travel to our facility; other than which no other travel is involved. Your travel cost will be reimbursed to you.

Clinical trials vary in length. Some are as short as a day or as long as a few weeks. You will be fully informed about how long you need to participate, and you may quit at any time though it is hoped that volunteers will remain in the trial so that high quality data can be provided.

After a volunteer concludes his/her participation in a study, Amaris Clinical will be happy to see if a volunteer qualifies for a new study. There is usually a short waiting period required between the ending of one study and participation in a new study. Just let the research staff know if you are interested in continuing your participation with us.

At the end of a study, the researchers analyze the data that were collected from all participants throughout the study. Findings and data collected about you will be compared to other participants. Doctors and specialists in biostatistics would conduct the analysis and report the findings. Data will also be shared with experts and various government agencies responsible for the approval of new drugs, biologics and devices. What happens when the study is over also varies from study to study. Generally, participation ends when the study ends.