Participate in Study > FAQs

General

• What do you do at Lambda?


We conduct clinical trials for pharmaceutical companies at our facilities across the world. The majority of our studies compare the levels of an investigational generic (or "copy") drug in your blood with that of a drug that is available on the market and allow us to gather information about the safety of the drug and how it affects people. "Investigational" means that the study drug has not been approved for use outside of research studies.


• Is it safe to participate in a research study?


At Lambda, your safety is of utmost importance. Our eligibility assessment process is designed to ensure that your overall condition meets strict study criteria. You will not be invited to participate in a study if there is concern that your participation could endanger your health. However, there is always some risk associated with taking any medication, including those prescribed by your family doctor and over-the-counter medications that you buy at a pharmacy. Before you participate in a research study, you will be fully informed of the risks associated with the study and provided with a list of the common side effects, procedures and purpose of the study in a written document called an "informed consent form" (ICF). All research studies involving human volunteers and the informed consent forms must be reviewed and approved by an Independent Ethics Committee (IEC), also known as an Institutional Review Board (IRB), before the studies begin.

We encourage you to take the study ICF home after your screening appointment and consider the study requirements and expectations fully before joining the study. Your participation must be voluntary and informed. The informed consent is NOT a contract. You may leave the study at any time, for any reason.

You may or may not experience side effects during a study. If you do experience side effects, our staff will assist you and provide medical care, if necessary. As a clinical research participant, you will be providing important information about how the drug we are testing is absorbed by and eliminated from your body and how it makes you feel. You will be expected to report all side effects or symptoms that you experience during the study to clinic staff even if they are mild or unrelated to the drug. Communicating this information is important for your safety and it will give us a better understanding of how the drug affects people.


• What is an Independent Ethics Committee (IEC) or Institutional Review Board (IRB)?


An Independent Ethics Committee (IEC) or Institutional Review Board (IRB) is a group of scientists, non-scientists, and community members who review and approve clinic research involving human subjects in order to ensure the protection of the rights, safety and well-being of study volunteers. An IEC or IRB has the authority to approve, disapprove, propose modifications to, or terminate proposed or ongoing research involving human subjects.


• What type of studies do you offer?


The majority of our research studies require healthy, non-smokers, age 18+ years who are not currently taking any medications, have no medical conditions (such as asthma, diabetes, high blood pressure, food allergies etc.), have no history of severe allergic reactions, and test negative for street drugs (such as cocaine, marijuana, opiates etc.) and alcohol. Volunteers must also meet certain height and weight requirements to participate in studies. The requirements for every study are not the same, and you may not always qualify for every study that we offer.


• Where are you located?


Our screening department is located at:
Ahmedabad
Near Gujarat High Court, S. G. Highway, Gota, Ahmedabad 380061, Gujarat, India
Tel: +91-79-40202020, Fax: +91-79-40202021
businessindia@lambda-cro.com

Mumbai
701, The Great Eastern Summit 'A', Plot No. 56, Sector 15, CBD/Belapur, Navi Mumbai 400614, India
Tel: +91-22-2756 2220, 2756 2224, Fax: +91-22-2756 2231
businessindia@lambda-cro.com

For further information, Please click the country flags to find a facility closest to you.


• Is my participation in a research study confidential?


At Lambda, precautions are taken in order to protect the privacy of our volunteers.
Your identity will be kept confidential at all times, except where disclosure is required by law. The Investigator (Study Doctor) will collect the results of your study-related tests and procedures and may also access your personal medical records at Lambda for health information such as past medical history and test results. Any information obtained will be confidential and released only as part of the report to the sponsoring company, who will only provide it to the government drug regulatory authorities. Records that are provided to the company sponsoring the research study will not contain your name. If the results of the trial are published, your identity will remain confidential.

Pre-Study

• How do I enrol for a study at Lambda?


We will create an information profile for you in our database, which will allow us to match you with suitable studies. Even though you may be matched to a study, you must provide informed consent and pass a medical screening exam to see if you qualify.


• What does a screening session involve?


Identification Verification
When you arrive at the medical screening area, the receptionist will verify your photo identification (Driver's License, Voter ID, Passport, etc.).
You will be provided with an information package that will include documents such as Consent Forms (ICF - documents that outline the screening and study procedures, risks and benefits of the research, the purpose of the study, potential side effects of the drug, etc.), a study schedule and examples of over-the-counter products you must avoid before and during the study.

Informed Consent
You will be given time to read through all ICFs on your own before reviewing the details with a staff member. You will be given the opportunity to have any and all questions you may have answered one-on-one with a staff member before signing the ICF. You will be given a copy of all ICFs to bring home. We encourage you to speak to your family, friends, or other individuals (such as your doctor) to help you decide if the study is right for you.

Screening Tests & Medical Examination
After signing the ICF, you will complete a series of medical assessments including a physical examination similar to what you may experience during a visit to your family doctor. The following assessments are commonly required during the screening process, not necessarily in this order:
Height and weight measurements
Blood pressure, heart rate, temperature, and respiration rate (vital signs measurements)
Electrocardiogram (ECG - a tracing of the heart's electrical activity and rhythm)
Urine sample collection (standard panel of tests to determine health status and testing for nicotine and drugs of abuse)
Alcohol breathalyzer
Blood sample collection (standard panel of tests to determine health status and pregnancy test for females, if required for the study)
Medical history and medications
Physical examination
Study-specific tests (e.g. for tuberculosis)
Other tests may be required depending on the study


After completion of the last activity, staff will verify that all documentation is complete before you leave.

Duration
We aim to complete screening visits within 4 - 5 hours; however, appointments may take longer depending on the length of the ICF and the tests required.


• Can you guarantee me a spot in the study?


Acceptable results from medical screening tests alone do not guarantee participation in a study. If you are selected for participation in a study, you will be given a pre-assigned subject number. To keep this number, you must follow all pre-study requirements and study restrictions and arrive on time for study check-in.


• Will my future study participation be affected if I attend medical screening at more than one facility in the same timeframe?


At Lambda, volunteers who intentionally affect the integrity of a study by participating in overlapping studies or failing to respect study lockout periods will be found ineligible for future studies at Lambda Therapeutic Research Inc. However, it is the dosing and blood collection in a study that generates a lockout period. You will not be screened for a study, if your current 'lockout' period will still be in place when our new study will begin.
Volunteers who fabricate or falsify health information will also be rendered forever ineligible for future study participation. Either of these acts poses a serious health/safety risk to the volunteer and jeopardises the integrity of study data.

Clinic Environment

• How should I prepare for study participation?


There are specific requirements for each study. Typically, you must not eat or drink specific foods and beverages (e.g., poppy seeds, regular or decaffeinated coffee, tea, products containing chocolate or cola, products containing grapefruit), prescription medications, over-the-counter medications including herbal/natural supplements, homeopathic remedies and vitamins, alcohol or street drugs for a specified period of time before your study participation.


• Is there anything I should NOT bring to the clinic?


We strongly recommend that you do not bring any valuable items to our clinics. However, if you choose to do so you will be solely responsible for them throughout your clinic stay.
For your privacy and that of your fellow volunteers, electronic devices with cameras (e.g., cell phones and laptops) are not permitted in the clinics.

In compliance with study requirements, the following items are not permitted in the clinic:
Outside food or drinks, including candies, chocolates, gum, juice or water
Medications (prescription and over-the-counter)
Herbal remedies or supplements
Alcohol
Street drugs
Cigars or cigarettes (for studies requiring non-smokers)


To ensure a safe and respectful environment for all volunteers and staff, the following items are not permitted in the clinic:
Pornographic material of any kind
Lighters, matches, etc.
Knives, guns or other weapons


• What will I eat?


We will provide all of your meals and snacks during your stay in the clinic. Meals will generally be identical in both/all study periods and must be consumed at scheduled times, which will be specific to your study. You will not be permitted to consume additional foods or drinks and some studies require fasting for a specific period of time before and after you take the drug. Sharing food of any kind is not permitted during studies.

Studies referred to as 'fed' studies include a meal that must be consumed completely within a specific time period - typically no more than 30 minutes - before taking the drug. A high fat, high calorie breakfast or a low fat breakfast are the most common of these meals.


• Does food preparation meet food safety regulations?


The facilities at Lambda and that of our caterer are inspected regularly. Our caterer must meet the requirements of our Quality Assurance program which includes review of inspection reports.


• Where will I sleep?


You will sleep in clinics in our facility. Clean bed linens, a pillow and a blanket are provided in all of our clinics.


• Is smoking allowed?


Smoking is not allowed in our buildings.


• How will I pass my free time in the clinic?


Each of our clinics has a big screen television and access to a selection of movies, newspapers and books.


• Is the clinic staff equipped to deal with emergency situations?


Our clinic staff members are provided with Basic Life Saving training [which includes Cardiopulmonary Resuscitation (CPR)] annually. Our Nurses also receive Advanced Cardiac Life Support (ACLS) training and our Nurses and Medical Screeners are provided with Automated External Defibrillator (AED) training.

In addition, we have Standard Operating Procedures in place to protect the health and well-being of our study volunteers by ensuring a quick and efficient response in emergency situations.


• How often is shared clinic space cleaned during a study?


Cleaning staff are scheduled to complete a full cleaning of clinic washrooms, dormitories and common areas at the beginning of each full clinic day. Additional cleaning will be conducted as needed or upon request. The cleaning staff sign a cleaning log after each cleaning which allows management to track adherence to cleaning schedules and identify areas that may need additional cleaning. Non-adherence to cleaning schedules brought to the attention of management will be addressed immediately with cleaning staff.

Study Conduct

• How will I know it is time for my study activities?


The specific study activities you will experience and the timing of these events are specific to each study and will be outlined in the study consent (ICF) and study schedule provided during your screening session. Activities such as drug and fluid administration, meal distribution, blood draws, vital sign measurements (heart rate and blood pressure) and electrocardiograms are common timed study activities that are based on your drug administration time.


• How often can I participate in a study?


It is extremely important for your safety and the integrity of study data that you do not participate in overlapping studies at more than one facility. Studies that involve taking a drug will have a minimum pre study lockout period.

Compensation & Expenses

• Will I receive compensation for my participation in a research study and is the amount standardised?


The compensation policy at Lambda is reviewed and approved for use by a Independent Ethics Committee (IEC) annually to ensure that study compensation and payment method do not unduly influence a volunteer's decision to participate in a study by compromising the voluntary nature of that decision or a volunteer's willingness to explore the risks and benefits of the study.

You will be compensated on a prorated basis according to a compensation disbursement schedule in which a percentage of the total study compensation is provided to you after each study period. Prorated compensation is less likely to pressure a volunteer into completing a study or concealing information in order to receive money, which simultaneously protects the safety of human study participants and the integrity of the scientific data.


• Will I incur any expenses by participating in a research study?


All medical screening and study tests, examinations, and medical care required as part of a study are provided at no cost to you. Study medication will be provided free of charge for the duration of the study.