Clinical Development
Strategy, solutions and insights to navigate the complexities of drug development.
Biostats combines deep industry expertise with a high-touch partnership model to deliver operational excellence across specialized services for small and mid-sized biotech companies.
Our flexible clinical development and regulatory solutions help navigate the complexities of early- and late-stage multinational programs. With dedicated study start-up teams, patient engagement experts, and tailored clinical monitoring—onsite, hybrid, or decentralized (DCT)—Biostats ensures seamless execution. We also offer comprehensive pharmacovigilance, data management, biometrics, and medical monitoring services.
Biostats’ global team brings extensive clinical and technical experience, fueled by a passion for innovative science. We are dedicated to helping biotech companies bring groundbreaking treatments to patients faster and more efficiently.
Therapeutic Expertise
Biostats offers comprehensive scientific and drug development expertise across complex therapeutic areas, advanced modalities, and medical devices. Our specialized focus includes oncology, neuroscience, infectious diseases, vaccines, cell and gene therapy, and rare diseases.
With a proven track record in these critical fields, Biostats supports biotech companies in navigating the unique challenges of drug development, helping to accelerate breakthrough treatments from discovery to delivery.
Clinical Strategy
Our clinical strategy services cover the full scope of product development, from exploratory IND and first-in-human studies to clinical development, marketing approval, and Phase IV post-marketing research.
We ensure seamless execution at every stage, helping biotech companies navigate complex regulatory pathways and accelerate their time to market with expert guidance throughout the drug development process.
Study Start-Up & Site Intelligence
We serve as your strategic and operational partner, optimizing study recruitment through a comprehensive, data-driven approach. Our holistic methods enhance site intelligence, improving site identification and selection while accelerating study start-up and driving faster patient enrollment.
By streamlining the recruitment process, we help ensure your clinical trials progress efficiently and achieve key milestones sooner.
Patient Recruitment & Retention
Our dedicated Patient Engagement team provides customized strategies to enhance patient recruitment, engagement, diversity, and compliance. We support a wide range of therapeutic areas and clinical study types, including on-site, decentralized, and hybrid trials, ensuring that your trials attract and retain diverse patient populations while maintaining high compliance rates.
By leveraging tailored solutions, we help optimize patient involvement and improve trial outcomes.