biotrial-preclinical
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Neuroscience

With an established pedigree in Neuroscience, Biotrial provides translational solutions that closely link non-clinical and clinical development using in-house data validation and back translation. Biotrial’s excellence is driven by our team of in house and external neurologists’ experts as well as project management teams with significant expertise in Neuroscience trials. We offer an end-to-end solution for your Early Phase needs or bespoke services according to your needs.

We understand that the development of Neuroscience compounds is a complex and challenging process. That’s why we work closely with our sponsors to develop a tailored clinical development plan that meets their specific needs and goals. We offer a wide range of services, including:

  • Preclinical services
  • Clinical Development
  • Biometrics services
  • Core Lab services
  • Bioanalysis services
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Oncology

We are committed to revolutionizing Oncology development by collaborating closely with a network of specialized researchers and clinicians. Our approach is tailored to the unique demands of the field, and we are dedicated to guiding our sponsors through every step of the process, from Non-clinical research, in-vitro and in vivo studies, to the initiation of Early Phase patient trials.

  • In-vitro and in vivo studies

Our in-vitro and in vivo studies team uses a variety of state-of-the-art techniques to assess the safety and efficacy of new cancer therapies in a controlled setting. We also offer services to support the development of new preclinical models for cancer research.

  • Early Phase patient trials

We work closely with our sponsors to develop trials that are tailored to their specific needs and that meet the highest ethical and regulatory standards.

  • Customized packaged services

Each sponsor has distinct needs, so we offer a variety of customized packaged services to support our sponsors’ Oncology development needs. These services can be tailored to meet the specific requirements of each sponsor, and can include a combination of our Non-clinical research, in-vitro and in vivo studies, and Early Phase patient trials services.

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Cardiology

At Biotrial, we offer a comprehensive end-to-end solution for your cardiology compound development, from preclinical to early clinical. Our experienced team of non-clinical and clinical experts is highly skilled in the scientific methodology and evolving regulatory requirements, ensuring that your studies are conducted to the highest standards and that your regulatory application is well-supported.

We understand that the development of cardiology compounds is a complex and challenging process. That’s why we work closely with our sponsors to develop a tailored clinical development plan that meets their specific needs and goals. We offer a wide range of services, including:

  • Preclinical services
  • Clinical Development
  • Biometrics services
  • Core Lab services
  • Bioanalysis services
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Rare Diseases

At Biotrial, we recognize that conducting clinical research studies for rare diseases presents unique challenges in terms of project management, site selection, and patient enrollment and retention. Given that children represent 50% of the rare disease population, the regulatory requirements specific to this age group represent an additional challenge that is mastered by our team of experts. We understand the urgent need to provide treatment options for patients living with rare diseases, and our full-service CRO offers innovative solutions to meet these challenges. Our services include:

  • Physicians with pediatric experience who understand the complexities involved in rare disease study design and management.
  • Experienced project team familiar with the challenges of rare disease and pediatrics clinical trials
  • Customized use of patient innovation tools and tactics to enhance the patient and caregiver journey and improve study participation and retention.
  • Data-driven insights and innovation applied throughout the study design and implementation process to ensure the highest quality data and results.
  • Integration of evolving global regulatory landscapes to ensure compliance with all applicable regulations and requirements.
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Gastroenterology & Hepatology

Non-Alcoholic Fatty Liver Disease (NAFLD) and non-alcoholic steatohepatitis (NASH)

Biotrial provides comprehensive solutions for Preclinical and Clinical studies. Our team of gastroenterologists has extensive experience in designing, planning, and executing clinical trials for a wide range of gastrointestinal (GI) disorders. We have established relationships with Key Opinion Leaders (KOLs) and sites ensuring access to specific patient population. Our medical expertise coupled with global regulatory knowledge and operational excellence allow Biotrial to deliver custom solutions for our clients for a broad spectrum of GI indications.

At Biotrial, we are committed to providing high-quality and comprehensive services adapted to the unique needs of each gastroenterology trial.

Gastroenterology encompasses many diseases and conditions, and our large experience includes constipation, diarrhea, gastroparesis, dyspepsia, Inflammatory Bowel Disease (IBD; Crohn’s disease, ulcerative colitis), antibiotic-induced dysbiosis, eosinophilic esophagitis, gastroesophageal reflux, irritable bowel syndrome (IBS), pancreatitis, short bowel syndrome, and more.

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Rheumatology & Immunology

Biotrial has extensive experience and offers targeted solutions to support the development of programs that address high unmet needs across immunologic disorders. Sponsors face challenges when developing new medicines in a crowded and dynamic marketplace, and Biotrial guides them every step of the way to deliver clear and high-quality trial outcomes. What sets us apart is:

  • A proactive approach to developing strategies that address evolving needs, such as diversity requirements in programs that meet FDA and EMA protocols.
  • An understanding of the importance of data quality in immunology clinical trials, recognizing the need for high-quality data to produce robust clinical trial outcomes.
  • Team of therapeutic experts and strong relationships with Key Opinion Leaders (KOLs) and sites ensuring access to specific patient population.
  • A comprehensive expertise and experience in immunology clinical trials across different therapeutic areas, such as gout, rheumatoid arthritis, psoriasis, osteoarthritis, systemic sclerosis, lupus, and more.
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Endocrinology Endocrine & Metabolic Disorders

Conducting metabolic studies can be a challenge due to difficulties in patient recruitment and ensuring study efficiency. It is critical to devote rigorous attention to regulatory strategies and safety data. At Biotrial, we have extensive experience conducting endocrine and metabolic clinical trials.

Our endocrine expertise spans: Type 1 and Type 2 diabetes, Dyslipidemia, Obesity, Metabolic syndrome, growth hormone disorders, and more.

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Infectious Diseases & Vaccines

At Biotrial, we have a wealth of expertise in bacterial, viral and fungal infectious diseases clinical trials. Our team includes medical, regulatory, operational, and laboratory experts who have extensive experience in infectious disease clinical research. What sets us apart is:

  • Our broad access to patient populations, allows us to recruit diverse and representative study cohorts.
  • Our team of health professionals provides expert care and oversight throughout the clinical trial process.
  • Our global network of research sites, decentralized community outreach, outpatient clinics, hospitals, and critical-care specialty centers, which enables us to conduct studies in diverse settings and populations.
  • Our data team ensures that the data collected is accurate, complete, and of the highest quality.
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Women’s Health

Biotrial possesses extensive knowledge and understanding of the regulatory drivers, treatment landscape, unmet needs, and recruitment strategies across a wide range of women’s health indications. We bring our clients significant experience in key areas of women’s health, including endometriosis, menopause-related disorders, contraceptives, uterine fibroids. Our dedication lies in providing:

  • Clinical subject matter experts given that multiple disciplines intersect with women’s health clinical research.
  • A team of experts with a wealth of expertise in women’s health development program and clinical trial operations.
  • Effective site and patient solutions to overcome potential challenges in conducting women’s health studies.
  • Prioritizing the patient’s well-being by utilizing targeted training.

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