Medical Writing, Data Management, and Biostatistics

GXPQS medical and technical writers have at least 10 years’ experience in the industry, with a broad range of experience writing in scientific research, clinical research, and medical affairs. We also have writers with significant writing experience in preclinical research and chemistry. GXPQS can provide comprehensive medical and technical writing services in all operational areas, successfully producing clearly written, well-organized, concise and scientifically valid documents that are compliant with current regulations and guidance and industry standards. Note that our regulatory writing capabilities are addressed under our Regulatory Affairs and Electronic Publishing tab.

Services:

Medical Writing

  • Literature searches, reviews, and manuscript and abstract preparation for professional meetings and publication

  • Medical writing (i.e. CSR, monitoring plans, Investigator Brochures [IBs], Safety/Pharmacovigilance Plans, Monitoring Plans, CSRs, etc.)  

  • Authoring and preparation of grant applications (SBIR, academic)

  • Technical writing (i.e. stability, qualification, validation protocols and reports; preclinical pharmacology, toxicology and PK reports; manufacturing process descriptions and development reports)

  • Preparation of presentations for regulatory authority meetings

  • Corporate Prospectus

Data Management and Biostatistics:

  • Preparation and review of BDM documentation (i.e. data management plans [DMPs], tables, listings and figures [TLFs], statistical analysis plans [SAP]) 

  • Clinical Biostatistical consulting includes review and approval of documents and report writing (protocol, SAP, TLFs, CSR, DSUR, ISE/ISS, etc.)

  • Statistical support for preparation of abstracts, manuscripts and presentations

  • Author, review and assess CRF/eCRF completion guidelines

  • Assist in resolution and tracking of clinical database queries and development of customized data reports

Contact Us

(713)-882-1987

info@gxpqsllc.com

8000 Research Forest Drive Ste.115-32 

The Woodlands, Texas 77382