hVIVO Clinical Statistics and Study Design
Our biostatistics and methodology specialists support your clinical programs from early development through to Phase III. We provide strategic guidance for study protocols—including study design, sample size determination, study objectives, and endpoint definition—ensuring scientific rigor and alignment with regulatory expectations.
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Statistical support across the full drug development cycle, from early clinical phases to Phase III.
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Expertise in complex statistical methodology, adaptive approaches, and handling missing data.
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Extensive experience supporting DSMB/DMC meetings, including unblinded statistician provision.
Our Capabilities
Our comprehensive biostatistics and study design capabilities include:
- Study design, sample size calculation, and endpoints definition
- Complex statistical methodologies and innovative trial designs
- Missing data strategies and advanced modelling approaches
- Regulatory support (Scientific Advice, PreIND, Special Protocol Advice)
- DSMB/DMC support: charter development, unblinded statistician, interim result generation
- CDISC standards support, including ADaM, define.xml and analysis data reviewer guides (ADRG)
Why Choose hVIVO?
We deliver the combined strength of a full service CRO and specialist biostatistics team to deliver robust and interpretable analyses results. We bring decades of multidisciplinary expertise, and a commitment to quality, that helps clients control timelines and costs without compromising scientific rigor.
