FAQ
Answers to your questions
Answers for volunteers, patients and sponsors.
General questions
What is a clinical trial?
It is a research study in people that evaluates whether a new medication, vaccine, device or procedure is safe and effective. When the results confirm it, that treatment may become the standard of care of the future. Every trial follows a protocol designed with scientific rigor, is reviewed by independent ethics committees (IRBs) and is overseen by health authorities such as the FDA.
What are the benefits and risks of participating?
As with any health decision, participating has potential benefits and risks that you should be aware of:
Potential benefits
- Early access to investigational treatments not yet available to the public.
- Close medical follow-up and more frequent health check-ups during the study.
- A more active role in managing your own health.
- The satisfaction of helping others gain access to better treatments in the future.
- Guidance on resources and support groups related to your condition.
Potential risks
- The study treatment may cause side effects, some uncomfortable and, in some cases, serious.
- The treatment may not work, or may not be better than the standard treatment.
- You may be assigned to the control group and receive the standard treatment or a placebo instead of the investigational treatment.
- Participation requires time: scheduled visits, travel to the site and, in some studies, stays of several hours or overnight.
During the informed consent process, the study team will explain in detail the specific benefits and risks of each study.
Who designs and conducts clinical trials?
They are designed by sponsors (pharmaceutical companies, government agencies or nonprofit organizations) and conducted by physician investigators and qualified clinical staff at research sites such as those in our network.
What is a control group or a placebo?
To measure the true effect of a treatment, some participants receive the investigational treatment while others form the control group, which receives the standard treatment or a placebo (a substance with no active ingredient). Assignment is usually random and will be explained to you before you decide to participate.
For volunteers and patients
Is it safe to participate?
Every study is approved by an independent ethics committee and by the health authority. Throughout the study, a medical team continuously monitors your health.
Is there any cost?
No. Study-related visits, tests and medications are provided at no cost to you, and you do not need health insurance.
Will I receive any compensation?
Many studies offer compensation for your time and travel. The amount depends on each study and is disclosed before you decide to participate.
What is informed consent?
It is a process in which the study team explains the objectives, procedures, risks and benefits. You sign only once you have understood everything and all your questions have been answered.
Can I withdraw from the study?
Yes, at any time and without giving a reason. Your decision will not affect your regular medical care.
Which medication is being tested?
Under confidentiality agreements with sponsors, we do not publish investigational products. During the informed consent process, you will receive all the information you need to make your decision.
Who can participate?
Each study defines criteria such as age, diagnosis or health status. Our team will help you determine whether you qualify.
How long does a study last?
It depends on the protocol: some last weeks and others several months. You will be informed of the duration and number of visits from the outset.
What happens if I experience an adverse event?
You will receive immediate medical care. In addition, you will have a contact available 24 hours a day throughout your participation.
How do you protect my data?
Your data are coded, and only authorized personnel can access your identity, in accordance with HIPAA and the data protection laws of each country.
For sponsors and CROs
In which countries do you operate?
The United States (Miami and Las Vegas), Mexico (Cuernavaca), Colombia (Bogotá) and Spain, in Europe. Coming soon: Ecuador (Guayaquil).
Which study phases do you conduct?
Phase I through IV studies, including healthy volunteer and bioequivalence studies, depending on each site's capabilities.
How do you protect product confidentiality?
We sign a confidentiality agreement before receiving the protocol, limit access to the essential team and never disclose product or sponsor names.
How do you ensure data quality?
Through standardized procedures across the network, electronic data capture, timely query resolution and internal quality controls.
What is your recruitment capacity?
We combine proprietary databases, physician referrals and community outreach, with access to Hispanic populations in the United States and Latin America.
Do you work with central or local ethics committees?
Both. We coordinate with central IRBs in the United States and with the local ethics committees required in each country.
Do you support regulatory submissions?
Yes. We prepare and follow up on submissions to FDA, COFEPRIS, INVIMA and ARCSA, as applicable.
Do you offer a single point of contact?
Yes. A project manager coordinates all network sites for your study.
Planning a clinical study?
Let's talk feasibility, timelines and target populations. We sign confidentiality agreements before receiving any information about your protocol.