♦ 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.


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Biometrics CRO Services – Statistical Services 

  • Knowledgeable and customer-focused support for randomization

  • Statistical programming

  • Statistical analyses

  • Statistical reporting

  • CDISC and ADaM submission-ready dataset development and quality control for submission compliance

  • Dataset development and quality control for integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE)

  • Tables, listings, and figures development and quality control

  • Tables, listings, and figures development and quality control for ISS and ISE

  • Interim analysis support

  • Annual clinical trial safety updates

  • Data monitoring committee (DMC), safety committee, and endpoint committee support

Statistical Services
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Biometrics CRO Services – Data Management  

  • Consulting (e.g., strategic program planning, protocol review, EDC selection)

  • Case report form (CRF) design utilizing the most up-to-date SDTM implementation guides

  • Database design, development, and maintenance

  • Data validation programming and testing, inclusive of edit check and manual review specifications

  • Data entry

  • Data cleaning and query management

  • Medical coding using WHODrug & MedDRA dictionaries

  • Serious adverse event (SAE) reconciliation

  • Management and integration of local laboratory reference ranges with CRF data

  • Integration, verification, and reconciliation of external electronic data

  • EDC selection and end-user training

  • Database lock and archival

  • Database transfer

Data Management
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Biometrics CRO Services – Data Science 

  • Development of bespoke visualizations to support data interpretation and monitoring

  • Algorithm development and the use of machine learning to support precision medicine

  • Maximization of the value of patient-generated data such as wearables and biosensors

  • Application of machine learning and artificial intelligence techniques to maximize the value of clinical data and its metadata

  • Identification of data sources and associated analytics to answer key questions

  • Development of data visualizations enabling teams to explore data

  • Analysis of historical and operational data, providing data insights and driving benefit

  • Integration and analysis of clinical data alongside electronic healthcare records (EHRs), real world data (RWD), and other omics datasets

Data Science
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Biometrics CRO Services – Medical Writing 

Clinical trial and program documentation

  • Protocol synopsis, protocols, and amendments

  • Informed consent forms

  • Clinical study reports (CSRs)

  • Safety narratives

  • Clinical development plans

  • Investigator brochure and patient information leaflets

  • Annual reports

    • Periodic safety update reports (PSURs)

    • Development safety update reports (DSURs)

    • Periodic benefit-risk evaluation reports (PBRERs)

Regulatory submission documents

  • Marketing applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)

  • Clinical & non-clinical summaries (Module 2)

  • Integrated summaries of efficacy and safety (Module 5)

  • Responses to agency reviewers

  • Regulatory briefing documents for agency meetings, including:

    • Pre-IND, end of phase 1,  end of phase 2/3, pre-NDA  and advisory committee

  • Orphan drug designation applications

  • Risk management plans

Medical Writing
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Biometrics CRO Services – Functional Service Provision

  • Offering a team of highly skilled medical writers, clinical data managers, programmers, and statisticians.

  • Partnering with clients to help them scale their teams when and as needed.

  • Providing customized support for all types of projects and programs.

  • Providing sponsors with access to dedicated resources to work across multiple programs.

Functional Service Provision


biostatistical consulting
biostatistical consulting
biostatistical consulting
biostatistical consulting
biostatistical consulting
biostatistical consulting

How can we help you? Please get in touch with us 24/7 for a free consultation.

Please call us at (650) 460-7431 or email us at: