ATV Trial Support Services | Turning Clinical Data into Insight

About

With over 30 years of experience in clinical and pharmaceutical development, ATV Trial Support Services provides expert SAS programming and medical writing for clinical trials.

ATV Trial Support Services supports pharmaceutical and biomedical companies and CROs in delivering (submission-ready) datasets, high-quality analyses, and regulatory documentation — ensuring accuracy, compliance, and efficiency at every stage.

The way of working is adaptable, enabling effective collaboration within multidisciplinary teams as well as strong performance when operating independently as a dedicated contributor. ATV Trial Support Services is flexible, engaged and fast in starting up projects and implementing unforeseen changes throughout a project.

ATV Trial Support Services is focused on contributing to meaningful advancements in clinical research.

Clinical research

Experience

✔ 30+ years in clinical research in Phase I-IV clinical trials

✔ Experienced in a great variety of therapeutic areas, including medical devices, rare diseases and vaccines

✔ Extensive experience within Contract Research Organizations (CROs) and the Pharmaceutical sector

✔ Trained in the biomedical field and gathered in-depth knowledge of the field over the years

✔ Owner and Director of AUTHOR (from 2001, acquired by Certara in 2021), a company that provided medical writing and statistical analysis of clinical trial data to global pharmaceutical and biotechnology companies

✔ SAS Programmer at the Netherlands Cancer Institute, Tramarko, Abbott, AUTHOR, and Certara

✔ Medical Writer at Abbott, AUTHOR and Certara

Services

ATV Trial Support Services offers a wide scala of SAS programming and medical writing services

SAS Programming

Developing SAS programs for the creation of CDISC-compliant datasets (SDTM & ADaM) and Tables, Listings and Figures, or any other type of format or type of document required
Developing SAS programs for data integration (integrated databases) and meta-analyses, e.g. for Integrated Summary of Safety/Efficacy
Developing SAS programs for developing large safety databases on safety data from clinical study databases, pharmacovigilance or publications/literature
Developing documentation describing the programming activities, including relevant CDISC documentation (define.xml and reviewers’ guide)
Performing Quality Control/Data validation on programs/output/documents from others
Handling (partial) statistical programs, provided by a statistician, and implementing these in the overall output documents/files
Ensuring high quality of programming output and related documentation
Preparing templates (standard programs) for SAS output that are consistent with FDA and ICH guidelines and with electronic submission guidelines (CDISC)
Providing input to statistical analysis plans, specifically relating to programming issues and template development

Medical Writing

Writing of Clinical Study Protocols (Phase I-IV)
Writing of Clinical Study Reports (Phase I-IV)
Writing of Investigator's Brochures (IBs)
Writing of large integrated submission ready documents such as Clinical Expert Reports, eCTD modules like the Integrated Summaries of Safety/Efficacy and the Clinical Overview
Writing of Informed Consent Forms
Writing of pharmacovigilance documents, such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURS) or patient narratives
Compiling appendices
Ensuring high quality of documents that are submission ready, i.e., fully navigable electronically (via bookmarking and linking) and easy to access, according to standards by regulatory authorities
Performing Quality Control on documents written by others
Preparing templates for clinical documents described above that are consistent with FDA and ICH guidelines and with electronic submission guidelines

Contact

If you have any questions or inquiries, please feel free to contact us using the form below