MEDICAL WRITING
Our Medical Writing team at PDS understands that you as our clients have unique challenges and needs, with every project being different.
Our focus is on TEAM which is why we work closely with you to offer pragmatic solutions and advice on your medical writing requirement to ensure new medicines for patients benefit.Our medical writing team here at PDS provides a wide range of skills and expertise key to the development of pharmaceutical and biotechnical medicinal products and medical devices.
Involving PDS as early as possible helps ensures you as our client has all the information needed to proceed with your development plans. Working with PDS early in the process means we can reduce time and cost, ensuring the project is efficient and successful.
Let us provide you with the perfect synergy between theoretical understanding and real time practical applications.
How can PDS help you
• Investigational Medicinal Products Dossiers• Investigator Brochures
• Nonclinical & Clinical CT Modules
• Protocols
• Lay summaries
• Clinical Study Reports (including abbreviated CSRs)
• Safety narratives
• Informed Consent Forms
• Risk Management Plans
• DSURs
• Clinical Evaluation Reports
• SOP Preparation
• Training Modules
Expertise
• Understanding of your objectives and data from the start• A problem solving approach gained from extensive and diverse experience
• Smooth integration and cooperation with your team from the start
• A structured plan for your project to ensure quality and timeliness for delivery
• Harmonization for your clinical trial design, operations, documentation, submission and publications to ensure your goals are achieved
• Expert up to date knowledge of clinical guideline, applicable regulations and guidance together with publication ethics
• All documents produced to the highest standard of clarity, accuracy and compliance
• PDS will work in accordance with your SOPs or with their established set SOPs, however you choose
• Reliable achievement of timelines and agreed budgets
• Open, honest, transparent and compliant project management at all times
• Pro-active not re-active feedback
Call us now on +44(0) 1476 512395 to discuss your project with one of our team.