Medical Writing:

  • Clinical Study Reports
  • Investigators Brochures
  • Subject Narratives

Medical Writing includes:

Genostats supports our clients in creating solutions that expansion efficiencies, productivity and quality in clinical trial from study start-up through completion. We support our clients from protocol writing to the final study report preparation with a highly collaborative exertion over our medical writing, bio-statistics and project colleagues.

Our comprehensive records are peer reviewed and experience a stringent quality assurance to guarantee medical and scientific accuracy.

  •   Clinical Study Reports
  •   Protocols
  •   Investigators Brochures
  •   CTDs/NDAs
  •   Subject Narratives
  •   Informed Consent Form
  •   Product Monograph
  •   Abstracts
  •   Synopsis
  •   Manuscripts
  •   Dossiers Writing(CMC/ADI)
  •   Slide Presentation/Conference/CME Documents

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Regulatory Affairs

Genostats Regulatory Affairs experts will be there to help control you through the additionally developing regulatory atmosphere.

Validation

The pharmaceutical business is regulated vigorously globally and is continually challenged by regularly advancing stringent directions.

Pharmacovigilance / Drug Safety

In the present pharmaceutical, biopharmaceutical and medical device product scene, you can't bear to miss crucial safety data about your products.

CDISC Advantages

CDISC is the most significant advancement for convenience in data trade without perplexity inside the pharmaceutical business and between the industry and regulatory authorities.

Clinical Data Management

Clinical Data Management We comprehend that high-quality data is significant for the achievement or failure of the clinical trial. Genostats provides Clinical Data Management service.

CLINICAL STAFFING

In the clinical industry, it takes many years and an extraordinary investment to bring a product to license.