Applying innovative approaches, to open new paths in cutting-edge science and world-class, technical capabilities for our search for medicines and molecules, that improve and make a difference in the quality of life of patients.
Guided by science and driven to improve the lives of patients, our research and development efforts focus on some of the most challenging diseases of our time.
Our goals in every developing molecule is to create a finished information component based on high level mechanical biology and rigorous trials that will give the development program the best chance of success while passing into the clinic.
Chronus BioPharm conducts clinical trials to evaluate new treatments and investigate possible new uses and benefits for existing drugs.
«Working together to drive innovation and development»
Chronus BioPharm is continually working to form new alliances, partnerships and collaborations to accelerate the discovery of new goals and help discover new medicines or therapies.
At Chronus BioPharm, our goal is to improve the lives of patients by researching and developing new and innovative drugs and molecules. Before these drugs or therapies are commercially available to patients, they must undergo clinical trials and be approved by a regulatory authority – such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) In Europe- and in Mexico by Cofepris, to treat a specific disease.
Approval by regulatory authorities around the world is the fastest way to help the largest number of people with a specific disease. For most patients, the only way to access these «research therapies or drugs” are to participate in a clinical study. However, patients with serious or life-threatening illnesses may not be eligible or be able to participate in clinical trials and their physicians may determine that they do not have other appropriate treatment options.
The mission of Chronus BioPharm is to discover, develop and offer innovative drugs, molecules or therapies that improve the lives of patients. We thank the patients, hospitals and clinics involved in the Clinical Trials.
Deciding to participate in a clinical trial requires careful consideration. In most cases, therapies investigated in clinical trials have not yet been approved by regulatory agencies. The benefits and risks of taking the treatment are not fully understood. By participating in a Clinical Study, you are helping the medical community determine if new treatments are safe and effective.
Before a clinical trial of a new drug or potential therapy can begin, Chronus BioPharm presents a Clinical Study Application (CAE) to the local regulatory agency that is Cofepris, and as it is called outside Mexico, New Research Drug (NRD) in other countries such as the United States. We work with local regulatory agencies such as COFEPRIS and around the world, including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The application describes the results of the preclinical tests and clearly describes the plan for conducting clinical trials.
Phase One trials emphasize safety and are usually performed with healthy volunteers. The goal is to learn how the potential therapy is metabolized and discover it’s most frequent and serious side effects.
The Phase Two trials gather preliminary data on how potential therapy works for people with the target disease or condition. Some trials compare the results of two different test groups: Participants who received potential therapy and participants who received a different treatment – either another drug or placebo. Researchers continue to pay close attention to safety and possible side effects.
In this final clinical phase, researchers collect more complete information about the safety and efficacy of a potential therapy. Trials may examine different patient populations, compare different dosage amounts of potential therapy, or combine it with other treatments.
Once the third phase is completed, potential therapy can be submitted to regulatory authorities such as COFEPRIS, FDA or EMA, which can then be approved as therapy for public use.
We conduct clinical trials both to determine the safety and efficacy of drugs or research therapies and to better understand how to use our approved products. This includes exploring new dosage forms or administering our drugs or molecules, or even trying them on a different disease.
Getting a new drug or therapy to the market can take 15 years or more, and only one of approximately 10,000 possible drugs or therapies ultimately identified is approved. For patients, this process may seem slow, but it is critical to ensure that therapy is safe and effective. The data collected during our trials are also invaluable for the Regulatory community such as Cofepris and even worldwide when we want to register a drug in other countries, as it sheds new light on specific diseases and on human biology in general.
Approval of a new drug or therapy requires years of research and development to ensure that a product is safe and effective. After a potential drug or therapy has been thoroughly tested in a laboratory and considered promising, it must pass through a strictly regulated approval process. This process involves three phases of clinical trials, or research studies, each with a different purpose and with a growing number of people.
Clinical Studies follow strict scientific standards that protect patients and help produce reliable test results. Each Clinical Study has a protocol, or study plan, that describes what will be done during the trial, how the trial will be conducted, and why each part of the trial is needed.
Before a clinical trial of a new drug or potential therapy can begin, Chronus BioPharm presents a Clinical Study Application (CAE) to the local regulatory agency that is Cofepris, and as it is called outside Mexico, New Research Drug (NRD) in other countries such as the United States. We work with local regulatory agencies such as COFEPRIS and around the world, including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The application describes the results of the preclinical tests and clearly describes the plan for conducting clinical trials.
Phase One trials emphasize safety and are usually performed with healthy volunteers. The goal is to learn how the potential therapy is metabolized and discover it’s most frequent and serious side effects.
The Phase Two trials gather preliminary data on how potential therapy works for people with the target disease or condition. Some trials compare the results of two different test groups: participants who received potential therapy and Participants who received a different treatment – either another drug or placebo. Researchers continue to pay close attention to safety and possible side effects.
In this final clinical phase, researchers collect more complete information about the safety and efficacy of a potential therapy. Trials may examine different patient populations, compare different dosage amounts of potential therapy, or combine it with other treatments.
Once the third phase is completed, potential therapy can be submitted to regulatory authorities such as COFEPRIS, FDA or EMA, which can then be approved as therapy for public use.
After a therapy has been approved, regulatory agencies often require additional studies. These postmarketing studies can assess therapy in new patient populations, monitor long-term impact, or compare therapy with other therapies.
Applying innovative approaches, to open new paths in cutting-edge science and world-class, technical capabilities for our search for medicines and molecules, that improve and make a difference in the quality of life of patients.
Guided by science and driven to improve the lives of patients, our research and development efforts focus on some of the most challenging diseases of our time.
Our goals in every developing molecule is to create a finished information component based on high level mechanical biology and rigorous trials that will give the development program the best chance of success while passing into the clinic.
Chronus BioPharm conducts clinical trials to evaluate new treatments and investigate possible new uses and benefits for existing drugs.
«Working together to drive innovation and development»
Chronus BioPharm is continually working to form new alliances, partnerships and collaborations to accelerate the discovery of new goals and help discover new medicines or therapies.
At Chronus BioPharm, our goal is to improve the lives of patients by researching and developing new and innovative drugs and molecules. Before these drugs or therapies are commercially available to patients, they must undergo clinical trials and be approved by a regulatory authority – such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) In Europe- and in Mexico by Cofepris, to treat a specific disease.
Approval by regulatory authorities around the world is the fastest way to help the largest number of people with a specific disease. For most patients, the only way to access these «research therapies or drugs” are to participate in a clinical study. However, patients with serious or life-threatening illnesses may not be eligible or be able to participate in clinical trials and their physicians may determine that they do not have other appropriate treatment options.
The mission of Chronus BioPharm is to discover, develop and offer innovative drugs, molecules or therapies that improve the lives of patients. We thank the patients, hospitals and clinics involved in the Clinical Trials.
Deciding to participate in a clinical trial requires careful consideration. In most cases, therapies investigated in clinical trials have not yet been approved by regulatory agencies. The benefits and risks of taking the treatment are not fully understood. By participating in a Clinical Study, you are helping the medical community determine if new treatments are safe and effective.
Before a clinical trial of a new drug or potential therapy can begin, Chronus BioPharm presents a Clinical Study Application (CAE) to the local regulatory agency that is Cofepris, and as it is called outside Mexico, New Research Drug (NRD) in other countries such as the United States. We work with local regulatory agencies such as COFEPRIS and around the world, including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The application describes the results of the preclinical tests and clearly describes the plan for conducting clinical trials.
Phase One trials emphasize safety and are usually performed with healthy volunteers. The goal is to learn how the potential therapy is metabolized and discover it’s most frequent and serious side effects.
The Phase Two trials gather preliminary data on how potential therapy works for people with the target disease or condition. Some trials compare the results of two different test groups: Participants who received potential therapy and participants who received a different treatment – either another drug or placebo. Researchers continue to pay close attention to safety and possible side effects.
In this final clinical phase, researchers collect more complete information about the safety and efficacy of a potential therapy. Trials may examine different patient populations, compare different dosage amounts of potential therapy, or combine it with other treatments.
Once the third phase is completed, potential therapy can be submitted to regulatory authorities such as COFEPRIS, FDA or EMA, which can then be approved as therapy for public use.
We conduct clinical trials both to determine the safety and efficacy of drugs or research therapies and to better understand how to use our approved products. This includes exploring new dosage forms or administering our drugs or molecules, or even trying them on a different disease.
Getting a new drug or therapy to the market can take 15 years or more, and only one of approximately 10,000 possible drugs or therapies ultimately identified is approved. For patients, this process may seem slow, but it is critical to ensure that therapy is safe and effective. The data collected during our trials are also invaluable for the Regulatory community such as Cofepris and even worldwide when we want to register a drug in other countries, as it sheds new light on specific diseases and on human biology in general.
Approval of a new drug or therapy requires years of research and development to ensure that a product is safe and effective. After a potential drug or therapy has been thoroughly tested in a laboratory and considered promising, it must pass through a strictly regulated approval process. This process involves three phases of clinical trials, or research studies, each with a different purpose and with a growing number of people.
Clinical Studies follow strict scientific standards that protect patients and help produce reliable test results. Each Clinical Study has a protocol, or study plan, that describes what will be done during the trial, how the trial will be conducted, and why each part of the trial is needed.
Before a clinical trial of a new drug or potential therapy can begin, Chronus BioPharm presents a Clinical Study Application (CAE) to the local regulatory agency that is Cofepris, and as it is called outside Mexico, New Research Drug (NRD) in other countries such as the United States. We work with local regulatory agencies such as COFEPRIS and around the world, including the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The application describes the results of the preclinical tests and clearly describes the plan for conducting clinical trials.
Phase One trials emphasize safety and are usually performed with healthy volunteers. The goal is to learn how the potential therapy is metabolized and discover it’s most frequent and serious side effects.
The Phase Two trials gather preliminary data on how potential therapy works for people with the target disease or condition. Some trials compare the results of two different test groups: participants who received potential therapy and Participants who received a different treatment – either another drug or placebo. Researchers continue to pay close attention to safety and possible side effects.
In this final clinical phase, researchers collect more complete information about the safety and efficacy of a potential therapy. Trials may examine different patient populations, compare different dosage amounts of potential therapy, or combine it with other treatments.
Once the third phase is completed, potential therapy can be submitted to regulatory authorities such as COFEPRIS, FDA or EMA, which can then be approved as therapy for public use.
After a therapy has been approved, regulatory agencies often require additional studies. These postmarketing studies can assess therapy in new patient populations, monitor long-term impact, or compare therapy with other therapies.