Biostatistics, Data Management and Medical Writing

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Biostatistics/Programing Consulting- Efficiencies and portability between clinical trial analyses:

  • Development and documentation of directory structures.

  • Macro development and efficiencies.

  • Program flow.

  • Programming tracking.

  • Issue tracking and resolve.

  • CDISC specification development and programming guidance.

  • Development of internal infrastructure to support the above activities.

Biostatistics and Data Management:

  • 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.

Medical Writing:

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

  • Medical writing (i.e. , 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; manufacturing process descriptions and development reports).