Biostatistics & Medical writing

Our preferred bio-stats and medical writing partner works with experienced SAS-certified programmers and expert medical writers trained in the pharmaceutical and CRO industry and with a sound information technology background. Our services and deliverables are in accordance with regulatory and industry standards. The biostatisticians are also accustomed to ongoing dialogues with regulatory authorities to ensure concurrence in the appropriateness of analyses. As they often work with Orphan Drug focused biotechnology companies which vary in size, they’re very used to coping with ad-hoc and tailored requests.

Examples

Our agile set-up and seasoned staff allow us to work with partners for unique software solutions other than EDC

Our agile set-up and seasoned staff allow us to work with partners for unique software solutions other than EDC

Our agile set-up and seasoned staff allow us to work with partners for unique software solutions other than EDC

Our bio-statistical services include:

Our medical writing service includes:

  • Protocol Statistical sections
  • Sample Size Calculations
  • Statistical Analysis Plans (SAPs)
  • Randomisation Lists
  • Blinded & Unblinded Statisticians
  • Statistical & Database Programming using SAS
  • Data Conversions
  • Tables, Listing and Figures for Clinical Study Reports (CSRs)
  • Clinical Study Protocols and Amendments
  • FDA Briefing Documents
  • Clinical Study Reports (CSRs)
  • Investigator Brochures (IBs)
  • Patient Informed Consent Forms (PICFs)
  • Executive Summaries for Efficacy or Safety
  • Data Safety Monitoring Board Charters
  • New Drug Applications (NDAs)
  • Orphan Drug Applications
Planetenweg 5
2132 HN Hoofddorp
The Netherlands
Tel: +31-23-55 63 220
Fax: +31-23-55 63 230
Email: info@psr-group.com
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