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Biostatistics and Statistical Programming Service Providers for Clinical Trials in the United States

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

6 January, 2021

Are you looking for biostatistics and statistical programming service providers for clinical trials executed in the United States?

PPD, Veristat, Cytel, Catalyst, StatsMetrika, SCiAN, and Sofpromed are recommended biostatistics and statistical programming service providers (Clinical Research Organizations (CRO)) for clinical studies conducted in the United States. 

PPD

PPD’s global biostatistics and programming team offers more than statistical analyses. 

We bring a deep understanding of the science of disease and compounds, as well as provide valuable upfront study design and comprehensive planning assistance that:

  • Accelerates decision making
  • Reduces risk of compromised timelines and errors
  • Ensures consistency and quality of global deliverables
  • Optimizes efficiencies with robust processes and global infrastructure

PPD’s comprehensive clinical biostatistics services can be tailored to meet the needs of your project:

  • Clinical development planning, study design, analysis and endpoint strategies, as well as supporting methodologies and statistical analysis plans
  • Randomization schedule creation and integration with investigational product management, interactive response technology (IRT) systems, as well as other project planning needs
  • Scientifically sound interpretation and reporting of results with efficient, quality production of full-output deliverables
  • Real-time analysis presentations and frequent, automated and secure web postings
  • Statistical consulting, design and operation of adaptive design studies for all phases of trials, from initial dose titration through post-approval services
  • PPD biostatistics has been engaged with International Conference on Harmonisation (ICH E9 (R1)) since the draft guidance was released and is leading a cross-functional working group to ensure full compliance at every stage

Veristat

Veristat’s Statistical Programmers have, on average, over 18 years of programming experience. 

They have seen the changes in the industry and work to implement all of the latest advances in data standards, technology, and industry requirements to create efficiencies in your trial data. 

With their rigorous QC process and client testimonials on their work, our programmers are able to offer our clients clean and precise clinical data throughout your program.

Our services include:

CDISC and ADaM Submission-ready Dataset Development and Quality Control for Submission Compliance

  • Analysis Dataset Development and Quality Control
  • Analysis 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

Cytel

The DNA of Cytel consists of industry-leading expertise in Biostatistics and Statistical Programming. 

Our dedicated programmers at Cytel have years of SAS® Programming expertise, combined with in-depth knowledge of specific clinical subject matter, which allows for competent and on-time completion of tasks. 

Due to the life science industry’s demand for reporting, summarization, high quality outputs, and complex statistical analysis, SAS® is the perfect programming method to ensure FDA compliance.

Our services include:

  • Study Analysis and Reporting
  • Tables, Listings and Figures
  • Generation of Analysis Datasets
  • CDISC Conversion (Mapping to SDTM)
  • Creation of CDISC documentation (Reviewer’s guide; Define.xml)
  • DMC Reporting
  • Patient Profiles and ad-hoc reports

Catalyst Clinical Research

Our integrated solutions blend programming expertise with the knowledge of protocol development, study design and sample size considerations and statistical analysis methodology. 

We’ll collaborate with you to determine methods for collecting, analyzing and presenting your data, while maintaining compliance with regulatory guidelines.

With the increasing costs of executing a clinical study, it’s critical to plan statistical analyses correctly earlier, to minimize, or even eliminate, the need to rework aspects of the original design, later. 

Our programming SOPs ensure the highest quality deliverables within the shortest turnaround time after database lock.

Our biostatistics and statistical programming services include:

  • Consultation on clinical trial design
  • Develop of statistical analysis plans (SAP)
  • Sample size/statistical power determination
  • Randomization schedule specification and generation
  • Data and Safety Monitoring Board (DSMB) and Clinical Events Committee (CEC) support
  • Interim and final reporting
  • NDA: Integrated Summary of Safety/Integrated Summary of Efficacy (ISS/ISE)
  • FDA and other regulatory interactions, including Advisory Committee meetings
  • Publication support and ad hoc analyses
  • CDISC mapping
  • Development of CDISC compliant ADaM datasets
  • Tables, listings and figures
  • Publication displays
  • Patient profiles
  • Ad hoc requests

StatsMetrika

At StatsMetrika, we provide high quality biostatistics services. 

With our wide-extensive knowledge and expertise in the field, our experienced biostatisticians and certified statistical SAS programmers provide guaranteed high-quality statistical solutions required for every phase of drug development based on the current methods and regulatory standards for successful execution of projects and provide all our clients the best matching up to the standards of their company’s and regulatory requirements at lower cost.

Our offerings are:

  • Statistical consulting for study design
  • Statistical Methodology including Hypothesis setup
  • Sample size and power calculations
  • Randomization and enveloping
  • Statistical Analysis Plan (SAP) and Annotated Mock Shells
  • Endpoints and analysis strategies
  • Creation and quality control of the study reporting data sets
  • Creation and validation of SDTM specification document
  • Creation and validation of SDTM datasets from legacy datasets
  • Generation and validation of Define documents
  • Creation and validation of ADaM dataset including specification writing
  • Creation of SDRG (Study Data Reviewer’s Guide) and ADRG (Analysis Data Reviewer’s Guide)
  • Table, Listing, Graph, other (TLGO) creations and validation

SCiAN

SCiAN’s Biostatistics department has an average of 14 years of experience in the design and analysis of clinical trials.  

Our experience ranges from parallel group, cross-over and Bayesian designs to complex (population) pharmacokinetic- and dynamic evaluations, therapeutic equivalence testing and large variable sample size sequential designs.

Our programming and analysis services include:

  • SDTM programming
  • ADaM programming
  • TLF programming
  • Unscheduled interim analyses
  • Post-hoc and exploratory analyses
  • Formal interim and final analyses
  • ISS/ISE analyses
  • Off-line data validation

Sofpromed

 logo sofpromed

Sofpromed offers biostatistics and SAS programming services for pharmaceutical and biotechnology companies focused on the development of new drugs. 

All our services are provided in compliance with ICH guidelines (E9 Statistical Principles for Clinical Trials and E3 Structure and Content of Clinical Study Reports).

Sofpromed’s biostatistics and statistical programming services include: 

  • Protocol development/review (statistics sections)
  • Power and sample size calculations
  • Statistical analysis plans (SAP)
  • Randomization processes, blinding/unblinding processes
  • Interim/final statistical analyses/reports
  • Pharmacokinetics (PK) analyses/reports
  • Data Safety Monitoring Boards (DSMBs) for randomized trials
  • Derived datasets
  • Database standardization for FDA submissions
  • SDTM and ADaM (annotated CRF, specifications, datasets)
  • define.xml
  • SAS programming of tables, figures, and listings (TFLs)
  • Statistical reports
  • Validation/auditing of statistical outputs

Please contact us at info@sofpromed.com for any questions about biostatistics and statistical programming services.

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

You may also be interested…

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com 

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