Acadustri Medical Writing

acogopng
Address:

377-399
London Road
Camberley
SRY GU15 3HL
United Kingdom


Email: enquiries@acadustri.com
Website: http://www.acadustri.com/
Phone: +44(0) 1276 415 770

Skills and Services:

Acadustri Medical Writing provides a bespoke medical writing service, including preparation of the following documents:

Pharmacovigilance Reports

  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • PSUR Addendums & Summary Bridging Reports
  • Risk Management Plans
  • Safety reviews & summaries
  • SAE narratives
  • Risk Benefit Assessments
  • ‘Response to Questions’ documents

Clinical/Regulatory Reports

  • Clinical study reports for phase I-IV trials to ICH guidelines
  • Investigator’s brochures
  • Study protocols & protocol amendments
  • Regulatory submission documents (CTD modules)
  • 'Response to Questions’ documents

Expertise:

We have expertise in general medical writing (study protocols, IBs, CSRs, CTD modules) and specialist credentials in pharmacovigilance medical writing. Our writers pride themselves on the flexibility to tailor our service to the most demanding requirements of our clients. We cover all biological sciences areas, but have particular expertise in the following therapeutic areas:

  • Oncology
  • Haematology
  • Endocrinology
  • Virology
  • Respiratory Diseases
  • CNS
  • Cardiovascular Disease

Other Information:

Acadustri Medical Writing also provides:

  • Individual and corporate training in pharmacovigilance medical writing
  • A bespoke consulting service to pharmacovigilance departments, to ensure compliance, quality and efficiency

We work in accordance with regulatory guidelines and your company's SOPs. Please visit our website for more information and contact us for a confidential discussion of your needs.