Bioclinical Research

Admerus Biosciences offers comprehensive bioclinical research services designed to support pharmaceutical and biotechnology companies throughout the drug development lifecycle. Our state-of-the-art facilities and experienced team deliver high-quality clinical research data that meets global regulatory standards.

With over a decade of experience in conducting clinical trials, we have established ourselves as a trusted partner for companies seeking to bring innovative therapies to market. Our integrated approach combines clinical expertise with scientific rigor to deliver reliable, actionable results.

Our team of clinical experts brings deep expertise across multiple therapeutic areas:

• Bioequivalence (BE) Studies - Generic drug development studies comparing test products to reference formulations
• Bioavailability (BA) Studies - Assessing the rate and extent of drug absorption
• Phase I Clinical Trials - First-in-human studies for safety and pharmacokinetics
• Phase II-IV Studies - Efficacy, safety monitoring, and post-marketing surveillance
• Special Population Studies - Studies in pediatric, geriatric, and other special populations

Our multidisciplinary team includes physicians, pharmacologists, biostatisticians, and regulatory experts who work collaboratively to ensure study success.

Our world-class facilities and capabilities include:

• 200-bed Clinical Pharmacology Unit - USFDA and EMA compliant facility
• Dedicated Phase I Unit - Intensive care monitoring capabilities
• Modern Bioanalytical Laboratory - LC-MS/MS platforms for sample analysis
• Electronic Data Capture (EDC) - Real-time data management and reporting
• Quality Assurance - Comprehensive QA programs ensuring GCP compliance

We maintain strategic partnerships with leading healthcare institutions to ensure access to diverse patient populations and specialized medical expertise.

Our extensive portfolio of clinical studies includes:

BA/BE Studies

• Single-dose and multiple-dose studies
• Fed/fasted crossover designs
• Replicate design studies
• Highly variable drug studies

Phase I Studies

• Single Ascending Dose (SAD) studies
• Multiple Ascending Dose (MAD) studies
• Drug-drug interaction studies
• Food effect studies
• Renal/hepatic impairment studies

Therapeutic Areas

• Cardiovascular
• CNS & Psychiatry
• Metabolic Disorders
• Anti-infectives
• Oncology

Our medical writing team provides comprehensive documentation support:

• Clinical Study Reports (CSRs) - Full and abbreviated reports per ICH E3 guidelines
• Protocols & Amendments - Study protocol development and optimization
• Investigator Brochures - Compilation and updates of safety information
• Regulatory Submissions - IND, NDA, ANDA, and CTD documentation
• Informed Consent Forms - Patient-friendly consent document development

All documents are prepared in compliance with ICH-GCP guidelines and regulatory requirements of major health authorities worldwide.

Certifications & Accreditations:

• USFDA inspected facility
• EMA GCP compliant
• ISO 9001:2015 certified
• CAP/NABL accredited bioanalytical laboratory

Contact our clinical team: clinical@admerus.com