Specialized Phase I Trials

Biotrial is specialized in Phase I healthy volunteer clinical trials. Our team of experts is dedicated to helping our clients move their drugs to the next development step faster without sacrificing the highest quality level of service.

We offer a range of other complimentary services for clinical trials, including:


Biotrials is a preferred CRO that specializes in clinical trials for new drugs. We have over 35 years of insight and a team of experts who can help you get your drug to market faster and more efficiently.


TQT/QTc Studies

Biotrial has extensive experience in conducting thorough QT (TQT) as well as phase I (SAD, MAD, DDI) trials with QT endpoints. Since the introduction of the ICH E14 guideline, Biotrial has carried out numerous TQT/QTc studies and has developed broad expertise in ECG capture and QT/QTc analysis.

Recognized as a leading provider and expert in QT exploration, Biotrial has more than 35 years of experience in cardiac safety services. We can help our sponsors to design effectively their first-in-human studies by adding early cardiac safety measures (early QT exploration) or a Thorough QT prolongation study (TQT) study.

Some sponsors choose to add early cardiac safety assessment to their first-in-human studies, while others wait for later development and perform a Thorough QT prolongation study.

We have been designing and conducting QT studies since the FDA E14 guidance was finalized. Our clinical trial services team has experience in both early cardiac safety assessment and thorough QT prolongation studies.

Having conducted hundreds of ECG/TQT studies, Biotrial can tailor their approach to meet the specific needs of each sponsor’s compound, either through the choice of study design, volunteer population, type of ECG recording, or data analysis. Our experts can provide the advice you need to maximize efficiency for your TQT Studies.

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Vaccine Trials

Biotrial is a preferred provider of healthy volunteer Phase I, patient phase II, and III vaccine trials to assess the safety, immunogenicity, and efficacy of new vaccines. We have dedicated ambulatory areas in our CPUs, specially designed for vaccine studies, and staff trained in clinical programs with vaccines requiring intensive monitoring.

We offer a comprehensive range of services for vaccine trials, including:

  • Study design and protocol development
  • Regulatory affairs support
  • Clinical trial management
  • Data management
  • Safety monitoring
  • Immunogenicity assessment
  • Efficacy assessment

We can tailor our approach to meet the specific needs of each sponsor, either through the choice of study design, volunteer population, or data analysis.

Imaging trials

Medical imaging techniques are useful for detecting, diagnosing, guiding, or monitoring the treatment of disease and have become an essential tool in clinical research for drug development.

With a dedicated team of imaging specialists, Biotrial regularly provides the highest quality imaging services for clinical trials from Phase I ( including those performed in our clinical units) to Phase IV, and across various therapeutic areas.

  • Neurology: Multiple Sclerosis, Alzheimer’s Disease
  • Oncology: RECIST 1.1, iRECIST, RANO
  • Cardiovascular
  • Musculoskeletal Disorders
  • Gastrointestinal
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Bridging Studies

Ensuring the safety and efficacy of drugs in new regions

Bridging studies are supplementary clinical trials that are conducted to support the approval of a drug in a new region. They are typically conducted when there is a concern about possible ethnic differences between the original and new regions, or when there is a change in the formulation, components, or active pharmaceutical ingredient of the drug.

If you are considering conducting a bridging study, it is important to work with a CRO company that has experience in this type of research and who can help you design and conduct the study, and navigate the submission process.

Biotrial has extensive experience in bridging studies, with success in a variety of therapeutic areas. We have conducted these global trials for drugs that are approved in the United States, Europe, and Japan as well as for drugs that are being developed for new indications or new populations.

The benefits of conducting bridging studies

  • Ensure the safety and efficacy of a drug in a new region: identify any potential concerns that may be unique to the new region. This can help to ensure that the drug is safe and effective for use in the new population.
  • Speed up the approval process for drugs in new markets: provide the data that agencies need to approve a drug in a new market. This can help to speed up the approval process and get the drug to patients sooner.
  • Reduce the cost of drug development: reduce the cost of drug development by avoiding the need to conduct a full clinical trial in the new region through the use of original data, which can save time and money.

Biologic/Biosimilar Trials

Advancing the Development of New Medicines

Biologic and biosimilar trials are conducted with large molecules derived from living cells via complex manufacturing processes. They require specific knowledge and strategy for the study execution.

Biotrial has extensive experience in the field of biologic/biosimilar compounds, such as antibodies, peptides, cell/gene therapies, and vaccines. We have conducted biologic/biosimilar trials in a wide range of therapeutic areas, including oncology, cardiovascular disease, and autoimmune diseases.

  • Expertise in Biologics/biosimilar development and experience in Europe and the US
  • EMA and FDA-compliant phase I clinical facilities (150 & 110-bed capacity in France and the USA)
  • Successful regulatory submissions
  • Large databases of volunteers to achieve challenging recruitment
  • High-quality process for Safety & PK studies
  • Network to source the comparators E.U and U.S. standard compliant
  • Large experience in BE studies data analysis
  • Trained staff to EMA and FDA Bioequivalence/Biosimilar guidance
  • Multiple studies with positive results and successful FDA inspections on Bioequivalence studies
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Renal/Hepatic Impairment Studies

Biotrial has designed, conducted, analyzed, and reported on many renal and hepatic impaired studies in recent years, with complete or reduced design across a wide spectrum of therapeutic areas.

We partner with leading external sites to ensure that our renal and hepatic impaired patients have the specialized clinical oversight they need. We leverage their databases to ensure we access the patient populations you need.

Depending on your needs, our experts can help with study design according to regulatory requirements. We select the best sites to meet your expectations and to perform the study within the expected timelines.

Biotrial Clinical Renal Hepatic Impairment Studies

Medical Device

Medical device clinical trials are essential for ensuring the risk and effectiveness of devices before they are made available to the public. These trials are conducted in a controlled setting to evaluate the device’s performance and to identify any potential risks.

We conduct multiple clinical investigations with different risk profiles of medical devices (Class I, IIa, IIb, and III) each year and follow specific regulations for these trials:

  • ISO 14155:2020 standard for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices
  • The new European regulation 2017/745 relative to medical devices applicable since MAY 26, 2021 in the EU


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