BIOMETRICS CRO
OUR TEAM’S EXPERTISE
♦ Expert statistical solutions
We guarantee quick turnaround time and the most accurate results possible.
♦ Friendly assistance
We are always here to help you with anything you need. We can help you through your entire project, from start to finish.
♦ Team of PhDs
Our team of PhDs has deep technical expertise. We are committed to understanding your unique challenges and delivering tailored solutions.
♦ Data standards
We can implement the latest advances in data standards.
HOW WE HELP CLIENTS

Biometrics CRO Services – Statistical Services
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Knowledgeable and customer-focused support for randomization
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Statistical programming
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Statistical analyses
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Statistical reporting
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CDISC and ADaM submission-ready dataset development and quality control for submission compliance
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Dataset development and quality control for integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE)
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Tables, listings, and figures development and quality control
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Tables, listings, and figures development and quality control for ISS and ISE
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Interim analysis support
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Annual clinical trial safety updates
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Data monitoring committee (DMC), safety committee, and endpoint committee support

Biometrics CRO Services – Data Science
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Development of bespoke visualizations to support data interpretation and monitoring
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Algorithm development and the use of machine learning to support precision medicine
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Maximization of the value of patient-generated data such as wearables and biosensors
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Application of machine learning and artificial intelligence techniques to maximize the value of clinical data and its metadata
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Identification of data sources and associated analytics to answer key questions
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Development of data visualizations enabling teams to explore data
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Analysis of historical and operational data, providing data insights and driving benefit
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Integration and analysis of clinical data alongside electronic healthcare records (EHRs), real world data (RWD), and other omics datasets

Biometrics CRO Services – Medical Writing
Clinical trial and program documentation
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Protocol synopsis, protocols, and amendments
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Informed consent forms
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Clinical study reports (CSRs)
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Safety narratives
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Clinical development plans
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Investigator brochure and patient information leaflets
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Annual reports
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Periodic safety update reports (PSURs)
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Development safety update reports (DSURs)
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Periodic benefit-risk evaluation reports (PBRERs)
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Regulatory submission documents
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Marketing applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)
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Clinical & non-clinical summaries (Module 2)
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Integrated summaries of efficacy and safety (Module 5)
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Responses to agency reviewers
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Regulatory briefing documents for agency meetings, including:
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Pre-IND, end of phase 1, end of phase 2/3, pre-NDA and advisory committee
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Orphan drug designation applications
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Risk management plans

Biometrics CRO Services – Functional Service Provision
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Offering a team of highly skilled medical writers, clinical data managers, programmers, and statisticians.
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Partnering with clients to help them scale their teams when and as needed.
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Providing customized support for all types of projects and programs.
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Providing sponsors with access to dedicated resources to work across multiple programs.
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