At Medivant Pharma, we are dedicated to advancing drug development through our comprehensive suite of services. With a team of seasoned professionals and a commitment to excellence, we provide unparalleled support across all phases of clinical research. Our expertise spans the following key areas:
- Biostatistics: Our biostatistics team offers robust statistical analysis and innovative solutions to ensure the integrity and reliability of your clinical trial data. The dynamics of our seasoned biostatisticians are in study design and protocol development, statistical analysis plans (SAP), interim and final analysis, data interpretation and reporting, as well as regulatory submissions and responses.
- Programming: Our programming experts deliver precise and efficient data processing and analysis. We excel in CDISC SDTM and ADaM dataset creation, custom programming for complex analyses, data visualization and reporting, automation of repetitive tasks, and quality control and validation.
- Data Management: Our data management team ensures the accuracy and completeness of your clinical trial data. We provide database design and build, data entry and validation, query management, data cleaning and reconciliation, and database lock and archival.
- PK-PD Modelling: Our pharmacokinetic (PK) and pharmacodynamic (PD) modelling services offer critical insights into drug behavior and efficacy. We specialize in non-compartmental analysis (NCA), population PK/PD modelling, simulation and prediction, dose optimization, and regulatory submissions.
- Data Science: Our data science team leverages advanced analytics and machine learning to derive actionable insights from complex datasets. We specialize in predictive modeling, data integration and harmonization, and data-driven decision support.
- Medical Writing: Our medical writing team produces clear, concise, and compliant documentation to support your drug development program. We offer clinical study protocols and reports, investigator brochures, regulatory submission documents (e.g., IND, NDA, BLA), manuscripts and publications, and patient narratives.
- Regulatory Affairs: Our regulatory affairs team ensures that your drug development program complies with all relevant regulations and guidelines. We offer regulatory intelligence and strategy, preparation and submission of regulatory documents, liaison with regulatory authorities, compliance audits, and post-approval maintenance.
- Clinical Development: Our expert team manages and oversees clinical trials to ensure they are conducted efficiently, ethically, and in compliance with regulatory standards. By leveraging advanced technologies and our global expertise, we accelerate drug development timelines, delivering robust and reliable results.
- Medical Affairs: We offer comprehensive medical affairs services to ensure the effective communication of scientific and clinical information. Our team of experts bridges the gap between research and healthcare professionals, enhancing the impact of medical innovations. By leveraging our extensive knowledge and experience, we support the successful integration of new therapies into clinical practice, ensuring optimal patient outcomes.
Partner with Medivant Pharma for reliable support. Contact us today for your organizational need!