Clinical Data Management, Biostatistics, and Statistical Programming Services for Clinical Trials

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

11 January, 2021

Sofpromed is a clinical research organization (CRO) providing cutting-edge clinical data management, biostatistics, and statistical programming services in SAS for phase I-IV clinical trials across multiple therapeutic areas such as oncology, cardiovascular, metabolic, central nervous system (CNS), dermatology, infectious, and respiratory diseases, among others.

As a full service CRO with extensive experience in clinical operations and drug safety, Sofpromed integrates its clinical expertise and knowledge into its data management and biostatistical capabilities. 

Sofpromed provides full clinical data management services for pharmaceutical and biotechnology companies focused on the development of new treatments in the United States, Europe, Asia-Pacific, Middle East, and Latin America. 

Our experienced Clinical Data Managers guarantee high quality clinical data from phase I trials to postmarketing studies.

In addition, our team of biostatisticians offers biostatistics and SAS programming services, in compliance with ICH guidelines (E9 Statistical Principles for Clinical Trials and E3 Structure and Content of Clinical Study Reports).

Sofpromed’s Clinical Data Management & Electronic Data Capture (EDC) System Build Capabilities

 Sofpromed’s Clinical Data Managers cover the full spectrum of data management tasks required in a clinical trial, including:

  • Development of the data management plan (DMP)
  • Development of the data validation plan (DVP) (including automatic query and edit check definition)
  • Development of EDC specifications (annotated CRF, variable definition according to the Clinical Data Acquisition Standards Harmonization –CDASH– standard)
  • Development of EDC completion guidelines
  • EDC build (forms, automatic query, and edit check implementation)
  • EDC testing and validation (internal and external user acceptance testing)
  • EDC trainings to sites
  • Development of customized status reports
  • Data review and cleaning (manual queries to sites including follow-up)
  • Serious adverse event (SAE) reconciliation
  • EDC system maintenance and technical support to sites (helpdesk)
  • Coding of adverse events, concomitant medications, and medical history

Sofpromed is a certified provider of Anju Software’s TrialMaster® EDC system, and offers it to clinical trial sponsors worldwide, along with its related data management and SAS programming services in compliance with Clinical Data Interchange Standards Consortium (CDISC) guidelines for FDA data submissions.

Sofpromed’s Biostatistics & Statistical Programming Capabilities

In the area of biostatistics, Sofpromed’s biostatisticians and statistical programmers provide the following services: 

  • Development and implementation of the randomization code (including randomization plan)
  • Statistical Analysis Plan (SAP)
  • Statistical programming tasks (generation of tables, figures, and listings, including reports).
  • Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM)-specific services for clinical data submissions to the FDA
  • Annotated CRF
  • Development of mapping specifications
  • SAS programming
  • Double programming
  • Data validations and transfers
  • Development of the Clinical Study Data Reviewer’s Guide
  • Define.xml 

Please contact us at info@sofpromed.com for more information about clinical data management, biostatistics, and statistical programming services for clinical trials.

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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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