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

Biometrics CRO Services – Data Management  

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

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