BIOMETRICS CRO
OUR TEAM’S ASSISTANCE
♦ Tailored solutions
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Our team of doctorates with deep technical expertise can efficiently deliver tailored solutions to solve your unique problems.
♦ Accurate results
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We guarantee timely turnaround time and the most accurate results possible.
♦ Friendly assistance
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We are always here to help you with anything you need.
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We can help you through your entire project, from start to finish.
♦ Data standards
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We can implement the latest advances in data standards.
♦ Unlimited free revisions for ten days
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Our team can provide unlimited revisions free of charge for ten days.
♦ Team approach of several specialists
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We can help you choose the correct methods, analyze your data, and provide expert feedback.
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We use a rigorous peer-review process to ensure the highest quality results.
♦ Endless support
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Our team can support you at every project stage.
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We offer unlimited email and phone support.
HOW WE HELP YOU
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.
RECENT PROJECTS
Allergic Patients
A global pharmaceutical company engaged our statistical consulting team to investigate the effect of allergies on treatment responses. We performed linear regression using Stata to examine this, ensuring all relevant assumptions were met. Our [...]
Relative Risk of Lung Cancer
We compared the difference in relative risk (RR) of lung cancer between the intervention and control groups. We performed an ANOVA using SPSS after ensuring that its assumptions were met. The intervention group exhibited [...]
Painkillers & Chronic Pain
A worldwide pharmaceutical company asked us to examine the impact of painkillers on chronic pain. Our team of statistical consultants conducted logistic regression using SPSS after carefully verifying that all relevant assumptions were met. [...]
Bending Stiffness
Our statisticians examined the differences in bending stiffness and strength based on fiber diameter. We conducted a MANOVA using Stata to test the hypothesis for this study, which confirmed a significant difference in bending stiffness [...]
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