Biometrics

EG Life Sciences is dedicated to helping you bring safe and effective treatments to market faster and more economically. Our services enable our clients to ensure compliance, streamline clinical trials, and positively impact lives.

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Expertise and Support in Niche Areas

Our Biometrics consulting services help pharmaceutical, biotechnology, and medical device companies navigate complex and highly regulated drug development processes.

We formulate precise solutions to support the full lifecycle from conception to market, including analysis, compliance, standardization, submissions, and more. Managing roadblocks is easier than ever with the foresight that our experience provides.

Focused Biometrics Support

Learn more about the specific obstacles and processes we help our clients overcome with ease:

Biostatistics

We enable successful clinical trials with top-tier Biostatistics support.
  • Trial Design and Protocol Development
  • Power Analysis and Sample Size Calculation
  • Randomization Schemes Generation and Management
  • Statistical Analysis Planning (SAP) and Shells Development
  • Integrated Regulatory Submissions of Statistical Sections
  • Independent Data Monitoring Committees (IDMC) Statistical Support
  • Ad-hoc Analysis and Publication (Abstract, Poster, Manuscript) Support
  • Integration of Data from EDC, IVR, and Adverse Event
  • Due Diligence

Statistical Programming & Analysis

Our experts ensure accurate reporting, successful electronic submissions, and much more.

Reporting (Tables, Listing, and Graphs)

  • SAE Reconciliation
  • Clinical Study Reports
  • Blinded Data Reviews (BDR)
  • Drug Safety Monitoring Board Data Reporting (DSMB)
  • Manuscripts, Publications, Posters Support
  • PK/PD Reporting
  • Legacy Data Conversion
  • Ad-hoc Reporting (Exploratory Analysis, Scientific Commercial Support, Label Changes)

Electronic Submissions

  • FDA Rapid Response Requests
  • Regulatory Queries (world-wide)
  • Third-Party Data Reporting Validation
  • SAS Transport Files and Define.XML
  • Annotated CRFs
  • Study Reviewer Guides (Data Attributes)
  • SDTM and Define Validation

Our Core Competencies

Our core competencies within Biometrics include the following areas:
  • Clinical Trials
  • Statistical Programming and Analysis
  • Biostatistics
  • Regulatory Submission Support (ISS/ISE, pooled analyses, regulatory authority responses)
  • Data Anonymization
  • Pipeline and Portfolio Management
  • Outcomes and Real-World Support
  • QMS and SOP Consulting
  • Independent Validation
  • PK/PD Modeling and Programming
  • CDISC Standardization and Data Mapping

Functional Outsourcing for Statistical Programming

Our client, a large, research-based pharmaceutical company, turned to us to identify, hire, train, and retain new talent to continuously handle their unique, complex requirements for their upcoming clinical trials.

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How do we deliver scalable and flexible solutions?

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