MEDICAL WRITING

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)