Biometrics
Your project deserves more than just routine solutions. Biotrial’s Biometrics Team provides support for seamless data management, analysis, and reporting across the spectrum of clinical trials, from Preclinical to Phase I-IV areas. Our comprehensive suite of services, enriched by years of experience, ensures the precision and reliability needed to drive success in your projects.
Biometrics Services Tailored for Your Project
As an End-to-End CRO, Our Biometrics Unit has accumulated extensive experience across diverse projects, including:
- Preclinical Studies
- Phase I / Clinical Pharmacology
- Phase II / III / IIIb Trials
- Phase IV Observational/NIS
- Retrospective Trials
- Early Access / Expanded Access
- Meta-Analyses and Pooled Projects
EDC & ePRO Solutions
Biotrial offers comprehensive software solutions, streamlining clinical data collection and management. Expertise in Medidata Rave and Clincase ensures a user-friendly and ergonomic experience, while an integrated randomization management process ensures a smooth and efficient process.
Data Management
Biotrial’s dedicated data management team excels in data collection, validation, and SAS programming, ensuring the accuracy, consistency, and integrity of trial data. A centralized data management and reconciliation approach provides sponsors with transparency and control over the entire data process.
Biostatistics
Biotrial’s biostatisticians and SAS programmers deliver end-to-end statistical services for clinical trials from Phase I to Phase IV. Their regulatory proficiency ensures the quality and compliance of statistical analyses, enabling informed decision-making. Biotrial also provides CDISC ADaM-compliant results and supports Independent Data Monitoring Committees (IDMC/DSMB) to guide clinical trial progress effectively.
Medical Writing
Biotrial’s dedicated medical writers collaborate with internal and external experts to produce high-quality protocols, reports, and regulatory documents. Biotrial possesses a strong scientific background, with an average of 10 years of experience in medical writing. Biotrial ensures eCTD compliance for all clinical trial deliverables, streamlining regulatory submissions.
Data standards
Biotrial ensures meticulous adherence to global standards, offering CDISC-compliant solutions for seamless data integration and submission readiness. Our expertise covers:
Data standards
- CDISC compliant (SDTM, ADaM, SEND)
- Define.xml, ADRG, cSDRG, nSDRG
- Deliverables for FDA and PMDA submissions
- ICH
- FDA 21 CFR Part 11
Data Tools
Empowering your projects with cutting-edge tools is our commitment. Biotrial utilizes the development of a suite of advanced tools to ensure efficiency, accuracy, and compliance. Our toolkit includes:
Biotrial Tools
- SAS® for deliverables programming
- EDC: Medidata Rave® and Clincase®
- ePRO: Medidata® and Clincase®
- Randomization (IRT, IWRS), Drug Supply, Coding, PV modules
- Phoenix WinNonlin®
At Biotrial, our commitment to excellence extends beyond services; it's a tailored partnership designed to propel your projects toward success. Whatever the complexity or phase, our Biometrics Unit stands ready to optimize your data, ensure compliance, and elevate the impact of your clinical trials.
ADDED VALUES
At Biotrial, our added values are not just statements; they are the foundation of our commitment to your success. We amplify the impact of your projects, providing a level of service that goes beyond expectations.
Methodology and Solutions Consulting
Our seasoned experts serve as your strategic partners in trial design. With a wealth of experience, they provide invaluable insights, helping sponsors craft trials that are not just executed but designed for success.
Solutions tailored to project needs
Whether it’s implementing cutting-edge technologies or assembling a dedicated team with the right expertise, our goal is to enhance the efficiency and impact of your project.
CDISC Expertise
Having delivered CDISC-compliant solutions to sponsors since 2009, we ensure your data meets international standards for seamless integration and submission.
Therapeutic Area expertise
Your project benefits from a depth of knowledge that ensures the precision and relevance required for success. Whether your focus is oncology, neurology, cardiovascular, or any other field, our team brings targeted expertise.
Our team
Biotrial’s Biometrics Team is not just a team; it’s a collective force of seasoned professionals committed to excellence, precision, and personalized service. It’s your dedicated ally in the pursuit of clinical excellence. With a commitment to precision, adaptability, and personalized service, we elevate your projects to new heights.
Experienced Data Managers: Navigating the complexities of data management requires experience and know-how. Our Data Managers bring a wealth of knowledge to ensure your trial data is not just managed but optimized for quality and efficiency.
Dedicated Biostatisticians: In the realm of statistics, precision is paramount. Our Biostatisticians, driven by dedication, work meticulously to extract meaningful insights from your data, guiding you with statistical prowess through every phase of your project.
Programmers: Programming expertise is indispensable. Our Programmers bring technical finesse to deliverables, ensuring your data is not just processed but transformed into actionable insights.
Medical Writers: Translating data into clear, concise, and compliant narratives is an art. Our Medical Writers possess the versatility to articulate your study’s findings, ensuring your research communicates effectively in both scientific and regulatory realms.
