Feature

MEDICAL WRITING

  • 12th July, 2016

We expertise in preparationof:

  • Manuscript Writing / Editing
  • Conference Abstracts / Presentations
  • Content, Design and Layout of Scientific Posters
  • Journal Selection / Submission
  • Editorial Writing
  • Product Monograph
  • Patient Information Leaflet
  • Summary of Product Characteristics (SmPCs)
  • CME Presentation
  • Pharma Sales Force training manuals
  • Newsletters
  • Visual Aids
  • Leave Behind Literature (LBL)
  • Literature Search and Review
  • Support product launch activities
  • Copy Editing, Proofreading and Formatting
  • Book Chapters

 

Standard Operating Procedures – development and reviews

Standard Operating Procedures (SOPs) in clinical trials are essential to support compliance with the regulations that govern the conduct of clinical research.

Essentially, establishing SOPs in clinical research ensures: better preparation when conducting clinical studies; thorough organization of the clinical research processes; professionalism; regulatory compliance; credibility and quality assurance – through a process of standardization, traceability and verification in clinical auditing and inspections. This is clearly defined as: “Detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55)

Our SOP development team can assist in writing, reviewing, updating and adapting Standard Operating Procedures based on your needs, and the structure of your organization.

We can assist in setting up new organization structures and policies for start up CROs and SMOs, which will involve the development of organization charts, job descriptions and departmental manuals, in accordance with ISO 9001:2000 specifications.

Systems with procedures that assure the quality of every aspect of the trial should be implemented.” (ICH GCP 2.13)

Medical Writing

  • 2nd June, 2016

Medical Writing is about communicating clinical and scientific data and information to a range of audiences in a wide variety of different formats. Medical writers combine their knowledge of science and their research skills with an understanding of how to present information and communicate it for the intended audience.

Medical writing is an essential and increasingly important activity required at every stage of developing a therapeutic product.

A clear, concise and professional presentation of study findings is an important factor in any development program. With a full complement of medical writing services, CliniExperts can provide all your documentation and writing needs. CliniExperts medical writing team has significant expertise in key therapeutic areas of pharmaceutical and biotechnology clinical development. They work directly with you to ensure consistency with your format and style while maintaining full compliance with regulatory requirements and International Conference on Harmonisation (ICH) guidelines. CliniExperts has a proven track record of timely delivery of quality medical writing deliverables coupled with outstanding customer service.

CliniExperts offers a comprehensive suite of medical writing services to support your clinical trial documentation needs from the early phases of development through post-approval. These services can be offered on a stand-alone basis or as an integrated part of a clinical trial, drug development program or medical information service.

CliniExperts medical writing services include clinical and regulatory writing like –

  • Protocols and protocol amendments
  • Informed Consent Forms/Patient Information Leaflets
  • Clinical study reports
  • Subject narratives
  • Investigator Brochures
  • Integrated summaries of safety/efficacy
  • Literature summaries
  • Clinical expert reports
  • INDs, NDAs, BLAs, CTAs (Module 2) summary documents
  • IND and NDA Annual reports
  • Safety Aggregate Reports (PSURs, PADERS, Line Listings, DSURs)