Our biostatistics and methodology specialists support your clinical programs from early development through postmarketing. 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.
Statistical support across the full drug development cycle, from early clinical phases to postmarketing.
Expertise in complex statistical methodology, adaptive approaches, and handling missing data.
Extensive experience supporting DSMB/DMC meetings, including unblinded statistician provision.
We support start-ups, biotech, academic and pharma, seeking robust study design and statistical guidance to accelerate development while ensuring methodological and regulatory rigour. Sponsors across a wide range of therapeutic areas rely on our expertise to minimise risk, optimise study power, and maintain efficiency throughout the clinical program.
Our Statistics, Study Design & Methodology service provides scientific, data driven guidance across every stage of clinical development. We support sponsors with study protocol design, sample size determination, endpoint definition, statistical strategy, and alignment with global regulatory expectations.
We work alongside you to define objectives, endpoints, and appropriate methods tailored to the development phase and therapeutic area.
We calculate sample sizes and provide extensive simulations if needed, using client’s or literature assumptions
We address complex statistical considerations, missing data strategies and innovative design needs.
We provide strategic support for regulatory interactions, including scientific advice, preIND preparation, and protocol justification. We also accompany and guide clients throughout their regulatory meetings to ensure clear, confident communication with authorities.
We provide expert support for DSMB/DMC activities, interim analyses, and unblinded reporting when required. Depending on your needs, we can serve as an independent statistician or as members of your DSMB/DMC to ensure objective oversight and methodological rigor.
Our comprehensive biostatistics and studydesign capabilities include:
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.
We support studies from early development through postmarketing.
Yes — we provide expertise in innovative and complex methodologies, including adaptive frameworks.
Yes — including Scientific Advice, Special Protocol Advice and preIND interactions.
We provide full support, from charter development to unblinded statistician provision or DSMB/DMC statistician.
Yes our biostatistics and study design team support all therapeutic areas.
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