Strategic Statistical Solutions for Real-world Data Problems.

Statistical analysis is a crucial part of clinical research. It involves strategic and compliant conversion of clinical research data to knowledge to support the early and successful development of new medicines. With ever changing dynamics of the regulatory in clinical industry, Global Pharma Tek is constantly making efforts to stay CDISC compliant, take data transparency initiatives, and ease cost pressures.

The Statistics management services at Global Pharma Tek covers all aspects of biostatistics, from developing a statistical analysis plan through preparing a statistical analysis report. Our full-service spectrum statistics management solutions are for all phases of clinical development and commercialization. We offer innovative biostatistics and statistical programming services owing to our extensive experience in biostatistical analyses and programming. We ensure metrics-driven delivery of clinical information processes from our global delivery centers across the United States, India, SEA, and China.

Global PharmaTek Offers following comprehensive biostatistics and statistical programming services:

Biostatistics

  • Development of Study Design including objectives, randomization etc.
  • Sample size calculation
  • SAP, mock tables and LoT
  • TLGs (tables, listings, graphs) reviews
  • eCRF design and review
  • Statistical report and input to CSR
  • Pharmacometrics and Pharmacodynamic analysis and modeling
  • Support to data and safety monitoring boards (DSMBs) and Clinical Events Committee (CEC)
  • Interim and final reporting, Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)
  • Exploratory analyses for abstracts, publications, and marketing

Statistical Programming

  • Development of statistical analysis plan and creations of mock shells
  • Develop Study Data Tabulation Model (SDTM) datasets and Analysis Data Model (ADaM) datasets and define.xml
  • Develop and validate programming specifications, analysis datasets and Tables, listings and figures (TLFs) for endpoints including safety, efficacy, pharmacodynamic (PD) and pharmacokinetic (PK)
  • Programming support for Clinical Study Report (CSR), Integrated Summaries of Efficacy (ISE), Integrated Summaries of Safety (ISS) and various other submissions
  • Develop Patient Profiles and In-text Tables
  • Submission-ready data services (STDM, ADaM, OpenCDISC, Define.xml)
  • Ad-hoc programming to support Clinical operations, Statistics, Data Management and Regulatory functions
  • Support Interim analysis, Database lock related activities, Data Monitoring Committee meetings, and regulatory submissions activities
  • Data conversion, migration, legacy to standard or SDTM mapping and conversion between different standards
  • Build standard macros as per client requirements

Operational & Strategic Statistics

At Global Pharma Tek, we are extremely focused on strategic development of a research design that is highly viable for clinical study. We are well-versed with the state-of-the-art data collection technologies to build a foundation on evidence-based, data-driven insights for successful completion of clinical research. We are dedicated and focused to provide exceptional operational and strategic statistics solutions to all our clients for all their needs during every aspect of drug development.

Expert Biostatistics Team

Our team of highly skilled data managers, statistical programmers and biostatisticians offer years of experience and extensive therapeutic expertise along with detailed knowledge of regulatory requirements to support all your biostatistical and programming requirements. Our team members are scattered globally and are constantly trained in recent regulatory requirements and new methodologies for successful execution of clinical research.

Customized Statistics Management to Fit your Goals

Our team is flexible to support your clinical research through our full-service program or as functional service provider. With our highly trained and skilled team, we are ready to take the complete responsibility of your statistics management or customize the solutions are per your needs. We offer expert analysis for your end-to-end or customized data programing needs from study start to finish.