Have you ever imagined being an active part in bioequivalence studies and clinical research that can lead to scientific discoveries, new medications, more efficient vaccines, and innovative health treatments capable of assisting thousands of people?  

Participating in these studies is an opportunity for anyone who wishes to contribute to science and people's health. By collaborating in the validation and advancement of treatments, you help ensure that medications reach the market safely and qualified.  

It is worth remembering that every medication available today in pharmacies has already gone through rigorous research stages, with the participation of people committed to scientific advancement.  

If you have already considered participating or want to better understand how these studies work, their differences, benefits, requirements, and registration methods, continue reading. In today's article, you will discover everything you need to know to enter this universe informed, safely, and responsibly.  

How do bioequivalence studies and clinical research work in Brazil? 

The truth is that many still do not know, but here in Brazil, it is possible to be a participant in studies with medications – and this is done safely and regulated by laws, clinical guidelines, and strict ethical statutes.  

Participants in these studies undergo necessary tests and validations for the launch of new medications in the market, having their health closely monitored by professional teams.  

If they have a specific disease, these individuals may be involved in research on new medications for it, receiving innovative treatments pioneeringly and with the potential to improve their health.  

DID YOU KNOW? In 2024, more than 500,000 clinical studies were underway worldwide.  

But of course, it is not mandatory to have any disease or health condition to participate in studies with medications.  

In other words: both people with a specific health condition and healthy individuals can be participants.  

There are 2 main types of studies for which a person can volunteer: bioequivalence and clinical research. Next, we will describe the differences (and similarities) between them and detail how to participate.  

Bioequivalence: what is it and how do the studies work?  

Bioequivalence studies evaluate whether a generic medication acts in the body similarly to its respective reference medication (hence the term 'equivalence').  

These tests aim to validate whether the generic, when administered similarly to the original, results in equivalent data for action and absorption of the active ingredient at the desired location. 

• Learn all the details about bioequivalence studies in the article “Bioequivalence: what one of the most important concepts for generic medications means”. 

  
  

The bioequivalence studies occur with the participation of healthy individuals, as any illness or health issue could interfere with the way the medication is naturally processed by the body.  

For those who wish to participate in these studies, the process is simple:  

1. Registration in bioequivalence study participation systems; 

2. Having the selected profile (learn more about this below);  

3. Being invited to undergo health examinations, including a medical consultation and laboratory evaluations.  

Once approved, the study itself takes place, with the administration of medications in a clinical environment. Samples (such as blood and urine) are collected at various stages throughout the procedures, reflecting the medication's action period. The participant is released after a monitoring phase.  

All data obtained during the research stages are analyzed by technical teams and serve as the basis for verifying the pharmacological principles under study.  

DID YOU KNOW? Synvia, the largest clinical research company in Latin America, has conducted over 1,600 studies with over 30,000 participants.  

Clinical research: what is it and what are the stages?  

Clinical Research seeks to determine the safety, efficacy, and effects of medications in the treatment of diseases. 

It always involves the presence of individuals, both healthy participants (in the initial phase – phase I clinical studies) and those with the target disease or health problem that the medication aims to treat.  

• Learn more on the topic in the article “Clinical research: what are the stages until a new medication reaches pharmacies?”. 

  
  

Clinical Research is a rigorous quality control stage for a medication. It is the last phase before it goes to market. Therefore, it includes studies that can last for years and involve thousands of people. 

The studies are divided into four phases:  

• Phase 1: this first phase is, in fact, far from being the “first”! Before it, many preclinical stages were conducted to prove the safety, usage profile, and efficiency of the medication under study. However, it receives this name because it involves the first contacts with humans. 

  
  In practical terms, Phase 1 involves testing the medication on a relatively small number of participants (20 to 100 healthy individuals), to evaluate safety, tolerance, and pharmacokinetic profile (that is, how it “works” inside the body), as well as the medication's safety.  
  
  

• Phase 2: the Phase 2 aims primarily to evaluate the medication's safety, tolerability, and efficacy. It includes people with the health condition that the medication intends to treat. The data collected in Phase 1 is now applied.  
  
  

  The research focuses on discovering the treatment's effectiveness and any side effects. Studies can last from months to 2 years and can involve hundreds of individuals who have the health condition or disease.  

  
  

• Phase 3: the Phase 3 widens the scope of Phase 2, bringing the new treatment to a much larger number of individuals with the condition (300, 3,000, and even more), for a comprehensive view of its effects in different populations with the same target disease, as well as its efficacy and the potential side effects it may generate.  

  
  

• Phase 4: the Phase 4 is for continuous monitoring after the medication has already been launched on the market. Thousands of individuals are monitored to ensure that the treatment works as predicted in the long term.  

  
  

Did you take note of everything? First, it is assessed how the medication acts in the body, whether it is safe and tolerated. Then, the effects concerning a specific health condition are tested – that is, how well it is able to treat a disease.  

Finally, it is compared how qualified it is regarding treatments already available on the market, and its long-term effects are monitored. Makes sense, right?  

DID YOU KNOW? You can track all ongoing clinical studies in Brazil through the platform ReBEC – Brazilian Registry of Clinical Trials.  

After all, what are the differences between bioequivalence studies and clinical research?  

Although bioequivalence studies and clinical research are related to the development of medications and the safety of treatments, they have quite different objectives, methodologies, and participant profiles.  

Understanding these distinctions is essential both for those who wish to volunteer and for those seeking reliable information on how medications are tested and approved. 

Next, you will find a comparative summary between these two types of studies, highlighting their main characteristics and purposes: 

• Objectives: bioequivalence seeks to compare how a generic medication and a reference drug work in the body. Clinical research aims to demonstrate the efficacy and safety of new treatments. 

  
  

• Methodologies: bioequivalence studies tend to be shorter (days or weeks) and involve few participants (less than 50). Clinical research can take years, and in the final stages, it involves thousands of people.  

  
  

• Participant profiles: for Bioequivalence, preferably, healthy participants are chosen. Clinical Research usually involves both healthy individuals and those with a specific health condition.  

  
  

While bioequivalence studies validate the equivalence between generic and reference medications, clinical research allows new substances and treatments to have their results analyzed within reality, paving the way for scientific and therapeutic advances. 

DID YOU KNOW? Although guidelines have existed since the 1970s, it is considered that the first clinical studies in Brazil involving healthy individuals occurred in 1989, at Unicamp.  

Another important milestone was in 1996 when Resolution 196 of the National Health Council was released, which establishes essential guidelines on how these studies should be conducted, created the “Free and Informed Consent Terms” that every participant signs, and defined the responsibilities of Research Ethics Committees and the National Research Ethics Commission.  

• Do you want to guarantee your participation in clinical studies that directly contribute to the advancement of science in Brazil? Click here and register now.  

Are clinical studies serious?  

Clinical studies are regulated and monitored by the internal guidelines of the health centers that coordinate them, as well as by ANVISA, INAEP (National Ethics in Research Committee), and also by CEP (Research Ethics Committee).  

Anyone who has participated in previous studies knows well: no medication research is conducted without the approval of Ethics Committees and adherence to good scientific practices at various stages.  

DID YOU KNOW? The safety and well-being of participants are priorities in clinical studies. That's why Synvia offers over 15,000 m² of complete and specialized infrastructure, being the largest analytical park in Latin America. 

In a center of excellence in clinical research, such as Synvia, each study participant is accompanied by a highly qualified team and in an environment that has specialized infrastructure. 

Participants undergo frequent medical exams and screenings to assess any variations and ensure that everything is going well.  

Ethics, scientific rigor, safety, and quality  

The conduct of any study involving human beings is based on internationally recognized ethical principles. These pillars are fundamental to ensuring that scientific advancement occurs in a responsible, transparent manner, and with total respect for the dignity of the participants. 

Next, learn about the four bioethical foundations that guide clinical research and paid bioequivalence studies: 

1. Autonomy: the participant has the right to freely decide whether or not to participate in the study after receiving all the necessary information about objectives, procedures, risks, and benefits.  
   
   

   This decision is formalized through the Free and Informed Consent Term (TCLE), a mandatory document that guarantees complete transparency and freedom of choice. 
   
   

2. Non-maleficence: no bioequivalence or clinical research study can directly or indirectly aim to cause physical, psychological, or moral harm to participants.  

   
   All potential risks must be assessed, minimized, and adequately communicated before the start of the research. The principle of non-maleficence is the ethical commitment of “not causing harm”. 
   
   

3. Beneficence: every research should seek to generate concrete benefits to society and participants, contributing to the advancement of medicine, the development of new treatments, and the promotion of health.  

   
   The well-being of participants in bioequivalence studies or clinical research is always prioritized over any scientific or commercial interest. 
   
   

4. Justice: all participants must be treated fairly and ethically, with just selection and without discrimination. The principle of justice ensures that no one is exploited or placed at undue risk, also ensuring confidentiality of health data - which is anonymized and protected according to the General Data Protection Law (LGPD). 
   
   These principles reflect the commitment of research institutions, such as Synvia, to ethics, scientific rigor, and the safety of participants. Following these guidelines is not only a legal requirement but a demonstration of respect for human life and responsibility towards the future of science. 

Click here to learn more about Synvia's study and discover how you can contribute to the advancement of science. 

And what about reimbursement, what are the rules?  

Clinical Research 

Remuneration in clinical research follows norms established by legislation, such as Law No. 14,874, which regulates participation in clinical studies in Brazil. According to this legislation, participants do not receive direct financial compensation for participation, in order to ensure that the decision to get involved in the study is voluntary and based on contributing to science and caring for health, rather than on financial incentives. 

Although there is no direct payment, participants are reimbursed for expenses related to participation, such as transportation and food. Additionally, they have free access to medical exams, treatments under evaluation, and specialized follow-up, which are significant benefits. 

Bioequivalence Studies 

Bioequivalence studies can be compensated. In these studies, healthy participants are financially compensated for the time and procedures they undergo, such as clinical and laboratory tests, necessary to evaluate the efficacy and safety of medications compared to reference ones. 

The compensation is allowed because participants are subjected to specific clinical interventions, and payment is a way to compensate for dedication and effort. Moreover, expenses related to participation, such as transportation and food, are reimbursed, ensuring that the participant does not incur losses by getting involved in the study. The compensation is always transparent and proportional. 

What type of study is ideal for you?  

If you are interested in participating in scientific research involving medications, contact Synvia's support team, learn about the steps, and register your information.  

If you are healthy, you can participate in bioequivalence studies. If you have any disease or health problem, you may be selected for research involving new treatments.  

DID YOU KNOW? Synvia is a leader in clinical research in Latin America, with over 20 years of experience, over 1,800 studies, and over 30,000 participants. 

With over 15,000 m² of specialized infrastructure, it has already contributed to more than 50% of generic and similar medications in Brazil reaching the market safely and effectively. 

Participation is always voluntary. Participants can choose to withdraw from studies at any time, being adequately guided by health teams and without suffering any type of 'punishment' or harmful actions.  

• Participate in paid clinical research with Synvia, the largest analytical park in Latin America, by clicking here.  

  
  

What are the direct benefits of clinical research for your health?  

By participating in a clinical study, you may gain early access to new treatments, often still unavailable on the market, which have the potential to significantly improve your health condition. 

Moreover, all medical follow-ups, exams, and monitoring are provided free of charge to the participant, ensuring safety and care at every stage of the process. 

This continuous care reinforces the ethical commitment of clinical research and bioequivalence studies to protect and value those who dedicate their time and trust to advancing science and health. 

I WANT TO PARTICIPATE IN CLINICAL STUDIES WITH SYNVIA. 

References and more information  

• Information about the number of clinical studies underway: https://clinicaltrials.gov/about-site/trends-charts  

• Details from the US FDA about the study process: https://www.fda.gov/patients/drug-development-process/  

• Resolution RDC 34 of ANVISA: Establishes the Information System of Pharmacological Equivalence and Bioequivalence Studies - SINEB and the National Registry of Volunteers in Bioequivalence Studies - CNVB. https://bvs.saude.gov.br/bvs/saudelegis/anvisa/2008/rdc0034_03_06_2008.html  

• ReBEC – Brazilian Registry of Clinical Trials: https://ensaiosclinicos.gov.br/