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PAREXEL® CLINICAL RESEARCH SERVICES
MEDICAL WRITING SERVICES
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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.
by PAREXEL’s Medical Writing Services team from 2009 to 2014
2300MEDICAL WRITING PROJECTS COMPLETED:
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MEDICAL WRITING SERVICES EXPERTS GUIDING YOU THROUGH YOUR JOURNEY
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PAREXEL MEDICAL WRITING SERVICES PRODUCES HIGH QUALITY DOCUMENTS ACROSS THE PRODUCT LIFE CYCLE Protocol DSUR,
IND ARIB
ICF
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 development efforts. We offer fast turnaround and a flexible, efficient process for any project large or small.
Key:ICF = Inform Consent FormIB = Investigator BrochureDSUR = Development Safety Update ReportsIND AR = Investigational New Drug Annual ReportsCSR = Clinical Study ReportCTRS = Clinical Trial Result SummaryPBRER = Periodic Benefit-Risk Evaluation ReportPSUR = Periodic Safety Update ReportPADER = Periodic Adverse Drug Experience ReportCTD = Common Technical DocumentNDA = New Drug Application
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Patient Narratives
Clinical Summaries (Module 2.7)
Clinical Overview
(Module 2.5)
Appendices Electronic Publishing CTRS
Post-marketing studies
PBRER, PSUR, PADER
Writing support during EMA/FDA/CFDA/PMDA
approvalCSR
Clinical sections of marketing applications (CTD/NDA)
Taking a new medicine or medical device from concept to market requires writing and submitting hundreds of thousands of pages of documentation. To minimize time to market, these documents and reports must be written accurately, precisely, and without errors while maintaining full regulatory compliance.
For more than 30 years, PAREXEL has helped its clients 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.
PAREXEL’s Medical Writing Services department includes a large number of scientists with significant expertise in the therapeutic areas that are important to you. We have handled thousands of writing projects around the world, can work in a number of different languages, and have a unique understanding of the regulatory requirements in the countries where you are developing and planning to commercialize your product.
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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 must be created. We then create a communication plan to inform you of progress every step of the way. You are assigned dedicated writing leads, and during the course of the project, the leads communicate regularly, and are 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.
A SERVICE MODEL THAT IS TAILORED TO FIT YOUR NEEDS
At PAREXEL, we understand your need to select a model that aligns with your own medical writing approach. We work with you to select the services you need and the contract model that fits your company, your project, and your budget. You can be assured that no matter which model you select, you have access to PAREXEL’s extensive global reach, broad therapeutic expertise, product development knowledge, process know-how, and the high quality that you would expect from one of the world’s leading biopharmaceutical service companies.
PAREXEL was the pioneer of strategic partnerships between pharmaceutical company and global biopharmaceutical services organizations, and we now offer you the opportunity to add our experts to your team when you need them. With our background, we know how to develop the cooperative teamwork to make the development journey simpler for you. Our team is aligned by function, therapeutic area, or project phase, as needed by you, and works exclusively for you.
PAREXEL MEDICAL WRITING SERVICES’ THERAPEUTIC AREA EXPERTISE — PAST 5 YEARS
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A SERVICE MODEL THAT IS TAILORED TO FIT YOUR NEEDS
Oncology Other Endocrine/Metabolism Neurology Rheumatology Infectious Disease Pulmonology Dermatology Pediatrics Cardiovascular Gastroenterology Genitourinary Hematology Obstetrics/Gynecology Allergy/Immunology Orthopedics Opthalmology Psychiatry
Oncology Other Endocrine/Metabolism Neurology Rheumatology Infectious Disease Pulmonology Dermatology Pediatrics Cardiovascular Gastroenterology Genitourinary Hematology Obstetrics/Gynecology Allergy/Immunology Orthopedics Opthalmology Psychiatry
We are always available for a conversation.
UNITED STATES
Frederick LeMoine Vice President, Business Development +1 919 294 5125 [email protected]
EUROPE
Graham Sanders Vice President, Business Development +44 1895 614 319 [email protected]
ASIA PACIFIC
Brian Yang Vice President, Business Development +886 2 21769525 [email protected]
WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.
© 2016 PAREXEL International Corporation. All rights reserved.
CORPORATE HEADQUARTERS
195 West Street Waltham, MA 02451 USA +1 781 487 9900
Offices across Europe, Asia and the Americas
www.PAREXEL.com
