Medical Writing Services 1 Medical Writing Services Experts Guiding You Through Your Journey

PAREXEL® CLINICAL RESEARCH SERVICES MEDICAL WRITING SERVICES 1 MEDICAL WRITING SERVICES EXPERTS GUIDING YOU THROUGH YOUR JOURNEY

PAREXEL’s Medical Writing Services team is one of the largest and most experienced in the biopharmaceutical industry, providing a wide range of high-quality documents from Phase I through to post-marketing and beyond. We can offer medical writing services for standalone projects, functional service partnerships or as a fully integrated service within our clinical research programs.

MEDICAL WRITING PROJECTS COMPLETED: 2300 by PAREXEL’s Medical Writing Services team from 2009 to 2014

2 PAREXEL MEDICAL WRITING SERVICES ICF PRODUCES HIGH QUALITY DOCUMENTS ACROSS THE PRODUCT DSUR, Protocol IB LIFE CYCLE IND AR

The Medical Writing Services group at PAREXEL is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation required to support your product Key: development efforts. We offer fast turnaround and a ICF = Inform Consent Form flexible, efficient process for any project large or small. IB = Investigator Brochure DSUR = Development Safety Update Reports IND AR = Investigational New Drug Annual Reports CSR = Clinical Study Report CTRS = Clinical Trial Result Summary PBRER = Periodic Benefit-Risk Evaluation Report PSUR = Periodic Safety Update Report PADER = Periodic Adverse Drug Experience Report CTD = Common Technical Document NDA = New Drug Application 3 Taking a new medicine or medical device from concept PAREXEL’s Medical Writing Services department to market requires writing and submitting hundreds of includes a large number of scientists with significant thousands of pages of documentation. To minimize time expertise in the therapeutic areas that are important to market, these documents and reports must be to you. We have handled thousands of writing projects written accurately, precisely, and without errors around the world, can work in a number of different while maintaining full regulatory compliance. languages, and have a unique understanding of the regulatory requirements in the countries where you are For more than 30 years, PAREXEL has helped its clients developing and planning to commercialize your product. get their new medicinal products into the hands of those that need them most by simplifying their journey to market. Whether you need help developing protocols or clinical study reports or any other regulatory documents, PAREXEL’s medical writing services experts are on hand to help you develop and launch your product.

Clinical Clinical Summaries Overview (Module 2.7) (Module 2.5) PBRER, PSUR, PADER

Clinical sections Writing support during of marketing CSR EMA/FDA/CFDA/PMDA applications approval (CTD/NDA)

Post-marketing studies

Patient Electronic Appendices CTRS Narratives Publishing

4 At the start of each project, the Medical Writing Services leadership team looks at your development program in terms of deliverables and the sequence in which they A SERVICE MODEL must be created. We then create a communication plan to inform you of progress every step of the way. You are THAT IS TAILORED assigned dedicated writing leads, and during the course of the project, the leads communicate regularly, and are TO FIT YOUR NEEDS easy to reach via telephone or email.

PAREXEL has a proven track record of delivering quality medical writing deliverables that can significantly condense study start up and reduce review times. We leverage our experience and the latest document management technologies to accelerate document preparation and facilitate submission times.

5 A SERVICE MODEL At PAREXEL, we understand your need to select a model PAREXEL was the pioneer of strategic partnerships THAT IS TAILORED that aligns with your own medical writing approach. between pharmaceutical company and global We work with you to select the services you need and biopharmaceutical services organizations, and we TO FIT YOUR NEEDS the contract model that fits your company, your project, now offer you the opportunity to add our experts to your and your budget. You can be assured that no matter team when you need them. With our background, we which model you select, you have access to PAREXEL’s know how to develop the cooperative teamwork to make extensive global reach, broad therapeutic expertise, the development journey simpler for you. Our team is product development knowledge, process know-how, aligned by function, therapeutic area, or project phase, and the high quality that you would expect from one of as needed by you, and works exclusively for you. the world’s leading biopharmaceutical service companies.

PAREXEL MEDICAL WRITING SERVICES’ THERAPEUTIC We are always available for AREA EXPERTISE — PAST 5 YEARS a conversation.

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6 WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

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