Stepping ahead with expert Clinical Biometrics Services and Expertise, positioning data as the vital element of your strategy.
As you strive to identify the asset that aligns seamlessly with your long-term goals, or explore promising markets and therapeutic avenues, Maxis Clinical Sciences is here as your dedicated partner, offering guidance at every critical juncture of bio-equivalence and all Clinical Trials phases.
When it comes to clinical trials, where every data point counts, Maxis Clinical Sciences has committed itself to simplifying the data generated by them so that you may confidently use them to improve patient care and treatment.
Clinical Biometrics Services
Building on data as a central element, we amplify analytical insights, uplift quality standards, and expedite reporting timelines. Our adept team of biometrics experts aligns with you from the outset to the conclusion, offering cohesive solutions and thorough reporting for regulatory submissions.
Our Clinical Biometrics services portfolio is used by Pharmaceutical, Biopharmaceutical, Biotechnology and Medical Device Companies, Clinical Research Organizations, Healthcare Providers.
Our Comprehensive Clinical Biometrics Services
Clinical Data Management / Clinical Data Science Services
Maxis Clinical Sciences offers bespoke data management services, designed to meet the distinct requirements of each client.
We cover the full spectrum of clinical data management tasks, from eCRF creation to database finalization.
Planning and Design
Data management plan formulation
Paper Case Report Form (pCRF) and Electronic Case Report Form (eCRF) design, development, and review
Clinical Database design, development, setup, testing, and validation
Data project management, including ongoing review of metrics and status reports
Data Collection and Storage
Clinical Trial Data Collection, Storage, Protection, and Retention
Data Capture, either Paper-Based or Electronic (EDC)
Local Lab Setup, Collection, and Review
Data Entry and Validation
Clinical Trial Data Entry, Review, Analysis, Migration, Loading, and Validation
Query management
Edit check specification, programming, and testing
Medical Dictionary for Regulatory Activities (MedDRA)
World Health Organization Drug Dictionary (WHO-DD)
Data Integration and Transfer
Electronic Data Integration and Transfer
External Data Validation, Reconciliation, and Integration
Clinical Database Transfers
CDISC Compliant Data Transfers (Study Data Tabulation Model (SDTM))
SAS datasets and SAS XPORT transport files
Quality Control and Reconciliation
Quality Control Activities
Serious Adverse Event (SAE) Reconciliation
SAE and External Data Reconciliation
Analysis and Reporting
IDMC and interim analysis planning and support
Interim and Final Database Lock Planning, Preparation, and Completion
Support Services
EDC Helpdesk Support 24/7
On-Site and Off-Site Clinical Data Management Services
Statistical Programming Services
Maxis Clinical Sciences enhances your data management framework with our adaptable statistical programming services.
Ensuring precision and efficacy throughout all testing stages.
Planning and Review
CRF, SAP Review and Input
Data Exploration and Programming Automation
Data Standards and Implementation
SAS Programming as per CDISC (SDTM/ADaM) Standards
Data derivation and mapping to CDISC standards
Implementation of CDISC SDTM and ADaM standards
Data Package Preparation
SDTM Data Package Preparation
ADaM Data Package Preparation
PK/PD Dataset Preparation
Integrated SDTM/ADaM Data Packages (ISS/ISE/ISI) Preparation
Statistical Analysis
Performance of Statistical Analysis
Performance of Interim Statistical Analysis
Data Reporting and Visualization
Generation of Tables/Listings/Graphs (TLGs) and Validation
Generation of Tables/Listings/Figures (TLFs) and Validation
Integrated Summaries of Safety and Efficacy (ISS & ISE) for Regulatory Submissions
Summary of Clinical Safety and Efficacy (SCS & SCE) for Regulatory Submissions
Specialized Reports and Profiles
Stand-alone Statistical Reports
Clinical Statistical and Study Reports Writing
Patient Profiles
Office of Scientific Investigation (clinsite.xpt, define.xml, reviewers guide, and OSI listings)
Data Integration and Validation
Program Validation
Integration of Databases Across Protocols
Biostatistics Services
Our seasoned biostatisticians offer comprehensive solutions across a range of therapeutic sectors.
We
guide pharma, biotech, and medical device companies through the intricate journey from early-stage
research to market authorization.
Study Planning and Design
Clinical Development Planning
Strategic Statistical Consulting
Clinical Trial Study Design
Protocol Development
Endpoint Development
Power/Sample Size Estimation
Study Sample Size Calculations and Randomization
Randomization Schemes
Data Management and Setup
eCRF Design and Review
Statistical Inputs to Clinical Study Protocol Development
Statistical Analysis Plans (SAP) Development and Interpretation
Adaptive Design Clinical Trial Planning, Simulation, and Implementation
Data Monitoring Committee (DMC) Services
SDTM and ADaM Dataset Preparation (Submission-Ready Dataset Packages)
Statistical Analysis and Modeling
Performance of Statistical Analysis
Interim Analysis/DMC
Statistical Modeling & Simulation
Exploratory Analysis
Pharmacokinetic and Pharmacodynamic Analyses
Reporting and Documentation
Statistical Tables, Data Listings, and Figures for Clinical Study Reports (CSRs)
Regulatory Submissions - Regulatory Guidance, Planning, and Meeting Representation
Integrated Safety and Efficacy Analyses (ISS/ISE/ISM)
Clinical Study Report
Informed consent forms and assent
Statistical Reports
Annual Reports (DSUR & PSUR)
Specialized Analyses and Studies
Observational Studies & HEOR (Health Economics and Outcomes Research)
Publications
Medical Writing Services
Maxis Clinical Sciences offers bespoke data management services, designed to meet the distinct requirements of each client.
Simplify your clinical trial data with our expert medical writing solutions. We provide robust support for Phase I-IV clinical trials and medical device study documentation.
Clinical Trial Documentation
Preclinical reports and summaries (Pharmacology/Toxicology/ADME)
Clinical development plans
Clinical study protocol (Phase I to IV
Protocol synopsis and amendments
Informed consent forms and assent
Investigator brochure and patient information leaflets
Clinical study reports (CSRs) - fully integrated (Phase I to IV)
Subject-level and safety narratives
Patient narratives
Lay summaries
Regulatory Submissions and Compliance
Pre-IND Meeting Briefing Packages for FDA
IND Application Summary Sections for FDA
Clinical study protocol (Phase I to IV
Clinical Trial Application (CTA) Summary Sections for EMA
Clinical Trial Applications in eCTD format (IND, CTA, and IMPD)
Investigator brochure and patient information leaflets
Marketing Applications in eCTD format (NDA/BLS, MAA, NDS, etc.)
Integrated Summaries of Safety & Efficacy (ISS & ISE)
Responses to Questions from Regulatory Authorities and Agency Reviewers
Regulatory Briefing Documents for Agency Meetings
Special Designation Applications (Orphan Drug Designation Applications, PIP/PSP)
Individual Case Safety Reports (ICSRs) and Aggregate Reports
Benefit/Risk Assessment Reports
Scientific Publications and Reviews
Abstracts and Manuscripts
Literature Reviews and Summaries
Medical and Scientific Literature Reviews
Additional Support Services
Medical Editing
Redaction Services
Standard Operating Procedures (SOPs)
Core Value Dossiers
CDISC Compliance & Data Standardization Services
Maxis Clinical Sciences ensures full compliance with CDISC standards
offering services that include process optimization, ADaM consultancy, and more for seamless eSubmissions.
Strategic Consulting and Planning
Process Improvement & CDISC SDTM / ADaM Implementation Consulting
Develop company standards based on CDISC current models
Optimize data flow from data capture CDASH to SDTM to ADaM to TLFs
Optimize clinical toolsets to achieve standards and return on investment
Knowledge transfer of data standardization process
Study data standardization plan (SDSP)
Data Standards Implementation
CDISC Compliant Case Report Forms
Gap Analysis of Study Documents and Data
CDASH Annotated Case Report Forms
Study Data Tabulation Model (SDTM) Annotated Case Report Forms
Trial Design Compliant Datasets
SDTM Compliant Datasets
Analysis Data Model (ADaM) Compliant Datasets
Subject-level and safety narratives
Integration of Controlled Terminology (CDISC and Sponsor-Defined)
Data Conversion Services
Legacy & Ongoing Study Data Conversions to SDTM Standards
SDTM annotated CRF (aCRF.pdf)
SDTM mapping specifications
Conversion of legacy raw datasets to SDTM datasets
Pooled analysis datasets (ISS/ISE)
Metadata and Documentation
Generation of Define.xml and Reviewer’s Guide
ADaM Metadata
SDTM Reviewer’s Guide (SDRG)
SDTM define.xml
ADaM specifications
ADaM define.xml
ADaM reviewer’s guide (ADRG)
Quality Control and Compliance Checks
Utilization of OpenCDISC (Pinnacle 21)
Comprehensive Quality Control Measures
SDTM compliance checks using OpenCDISC / Pinnacle 21 Validator
ADaM compliance checks using OpenCDISC / Pinnacle 21 Validator
Regulatory Submission Support
Data handling reports
FDA reviewers’ guide
Electronic common technical document (eCTD) structure
Why Choose Maxis Clinical Sciences for Biometrics?
Our biometrics division is a model of excellence, having led over 500 projects spanning regulatory communications, data management efforts, biostatistics, and statistical programming. Join forces with us to benefit from:
A dedicated team of data experts, each with an impressive track record spanning more than a decade in the industry.
Leadership enriched with profound industry insights, guided by our seasoned biostatistician with a career spanning over twenty fruitful years
A structured oversight plan that is meticulously designed to mitigate risks, maintain quality standards, and increase project team productivity.
Key Differentiators
Purpose-fit Solutions
Tailored approaches to meet diverse project needs.
Real-time Monitoring
Swift identification and resolution of issues, ensuring consistent project execution.
Technology Integration
Capability to seamlessly integrate with over 40 of clients’ existing technologies.
Positive Client Feedback
Exceptional score of 9 reflecting our proficiency in technical integration and client satisfaction.
Team Deployment
Teams that are not only skilled but can be readily deployed to address diverse requirements.
Operational Excellence
Strict contracts and IT system monitoring to prevent moonlighting, ensuring dedication and commitment.
Biometrics Resources - Current Teams
Programming Resources
Varied skills in Statistical, R Programmers, and Macro Programmers.
Biostatisticians
5+ years to Principal Managers.
Service Leads
Global Service Leads, Service Leads.
User Acceptance Testing Leads
UAT (Leads, Senior).
Our expert team is well-versed with wide Therapeutic Areas & Regulatory Standards including.
FDA 21 CFR Part 11
Current Good Clinical Data Management Practices (cGCDMP)
International conference on harmonization Good Clinical Practices (ICH-GCP)
Health Insurance Portability and Accountability Act (HIPPA)
CDSIC Registered
Clinical Data Interchange Standards Consortium (CDISC)
Analysis Data Model (ADaM)
Study Data Tabulation Model (SDTM)
Proven Success Metrics
90%
On-time delivery rate
24/7
Global Delivery
3/10
Pharmaceutical companies as clients
3+
Regions (US, EU and India) with purpose-fit FSP Teams
30%
Proven Cost Reduction
Connect with us to learn more about our Clinical Biometrics Services and how we can support your needs.
