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science files

Medical Writing

Sciencefiles facilitates the preparation of key documents for registration of Phase I through IV clinical trials for both pharmaceutical products and medical devices and in various therapeutic areas.

Our services include:
  • Clinical trial protocol development
  • Development of patient information leaflets and informed consent forms
  • Creation of Clinical Investigator’s Brochures (with optional development of nonclinical and/or clinical study reviews)
  • Review of already prepared protocols or any other essential documents (with optional preparing amendments in accordance with a regulatory authority’s comments)
  • Literature review and summary of nonclinical and clinical studies in the Common Technical Document format (CTD format)
  • Risk management plan development for pharmacovigilance

Sciencefiles specialists have profound knowledge and expertise in scientific medical writing. We can prepare the following scientific or medical marketing texts:

  • Research articles
  • Review articles
  • Systematic reviews
  • Meta-analyses
  • Healthcare provider information materials
  • Patient information materials

Data Management
Sciencefiles specialists facilitate the following data management tasks:

  • Development of data management plans
  • Creation of patient diaries
  • CRF annotation
  • Database description/development
  • Development of paper/electronic case report forms (CRF/eCRF)
  • Database creation
  • Training of data entry specialists
  • Development of database entry guidelines
  • Incoming control of paper CRFs
  • Data entry by one or two data entry specialists
  • Quality control of databases
  • Development of data validation plans
  • Validation of data in the database
  • Encoding of database data
  • Data query assignment
  • Data extraction from databases
  • CRF storage
  • Checking for completeness of a CRF before its return
  • CRF destruction

Biostatistics

Biostatistics is the area in which Sciencefiles specialists have many years of experience in clinical trial data analysis.

We offer the following services:
  • Sample size determination
  • Generation and/or formatting of randomization tables for envelopes or IxRS
  • Statistical analysis plan development
  • Statistical analysis plan review
  • Statistical analysis with generation of a statistical report
  • Final study report compilation