Life Smile India facilitates clinical trials for research and development based medicines / drugs - the research studies designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. These clinical trials are used to determine whether new drugs treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

As a research and development company Life Smile conducts and facilitates offshore clinical drug research trials outsourced to India. The stem cell clinical trial and clinical drug trials for cancer, aids, diabetes, obesity and hypertension etc. diseases and disorders can be facilitated by Life Smile on low cost overseas in India. These trials can be performed by our partner health care organizations, medical institutes, hospitals, clinic facilities under supervision by scientists, technicians, doctors, physicians, nurses and medical professionals.

Basically, the clinical trials are conducted in four phases:

Phase I tests a new drug or treatment in a small group;

Phase II expands the study to a larger group of people;

Phase III expands the study to an even larger group of people; and

Phase IV takes place after the drug or treatment has been licensed and marketed.

Phase 1 trials: is a closely monitored clinical trial of a drug or vaccine conducted in a small number of healthy volunteers. A Phase 1 trial is designed to determine the vaccine's safety in humans, its metabolism and pharmacologic actions, and side effects associated with variable doses.

Phase 2 trials: involves controlled clinical study of a drug or vaccine to identify common short-term side effects and risks associated with the drug and to collect some information on its effectiveness against the disease being studied. Phase 2 trials enroll some volunteers who have the same characteristics as persons who would be enrolled in an efficacy (Phase 3) trial of a drug or vaccine. Phase 2 trials enroll up to several hundred participants and have more than one arm.

Phase 3 trials: expanded controlled and uncontrolled trials conducted after preliminary evidence suggesting effectiveness of the drug at an optimally selected dose and schedule has been obtained.

Phase 3 trials: are also intended to gather additional information about safety needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 trials usually include several hundred to several thousand volunteers.

Phase 4 trials: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

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.

Types of Clinical Trials:

Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic trials: are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials: test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials): explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

Play an active role in their own health care.

Gain access to new research treatments before they are widely available.

Obtain expert medical care at leading health care facilities during the trial.

Help others by contributing to medical research.

Risks

There are risks to clinical trials.

There may be unpleasant, serious or even life-threatening side effects to experimental treatment.

The experimental treatment may not be effective for the participant.

The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

You are welcome to contact Life Smile at: lifesmile@gmail.com