Expanding our global footprint with AUTHOR! and Insight Medical Writing
In the current complex global regulatory environment pharmaceutical sponsors require innovative partners that can support critical elements of the drug development process and manage simultaneous submissions to multiple global regulatory agencies. Certara is uniquely positioned to accelerate these steps through its regulatory talent and technology.
In Europe Insight Medical Writing, AUTHOR! and Synchrogenix have combined to form Certara Insight, a center of excellence for regulatory writing, publishing and associated Certara services.
Certara Insight’s experienced team in the UK and Europe join the US regulatory team in accelerating approval and access to the latest medical innovations through a unique combination of customized regulatory strategy, document authoring, and operational solutions.
明確で簡潔な規制文書は、医薬品開発プログラムの成功に不可欠です。Our highly qualified team of writers include PhDs and MDs who cover all stages of the drug development process. Our focus on quality is second to none.
Our services include the preparation of:
- Clinical development plans
- Protocols and protocol amendments
- Pediatric information plans
- Briefing documents
- The Common Technical Document (CTD)
- Clinical and non-clinical summaries
- Clinical and non-clinical overviews
- Marketing Authorization Applications (MAAs)
- New Drug Applications (NDAs)
- Regulatory responses
- Clinical study reports (Phase I to IV)
- Clinical evaluation reports
- Integrated summaries (ISE and ISS)
- Plain language summary (簡易な要約)
Pharmacovigilance Documentation and Services
Our team of EU and UK QPPV`s, Graduated Plan Officers and Drug Safety Officers has a broad expertise in setting up pharmacovigilance systems for marketing authorization holders and applicants. For over 14 years, Certara Insight has been at the forefront of the development of EU Risk Management Plans (RMPs). This expertise extends to all safety documents.
- Pharmacovigilance System Master File (PSMF)
- Risk management plans
- Post authorization safety/efficacy studies (PASS/PAES)
- Periodic safety update reports/Periodic benefit-risk evaluation reports (PSURs/PBRERs)
- Development Safety Update Reports (DSURs)
- Signal detection, case management and literature screening
- Vendor management and quality system set up and maintenance
Medical Marketing and Publications
Clinical data are accurately and concisely presented for a variety of different audiences.
- Presentations, posters, and abstracts
- Scientific congress coverage and website content
- Publication planning
- Medical information materials
- Design and digital support
- Product monographs
- Attendance at advisory board meetings
Data Disclosure and Transparency
Transparency in clinical development has been progressively formalized in legislation that requires data to be made publicly available in the form of plain language summaries, data registries and anonymized submission documents. While information that is either commercially sensitive or might identify individual patients may be anonymized in the public documents, this content must be agreed in advance with the appropriate authority, and achieve the right balance of utility and privacy.
Certara Insight is well placed to support and facilitate your data transparency obligations.
- Data and document anonymization and redaction management
- Accurate and efficient clinical trial postings to clinicaltrials.gov, clinicaltrialsregister.eu, EudraCT, CTIS, and other applicable worldwide registries
- Plain language summary (簡易な要約)
- Patient engagement
Electronic Submission Publishing and Support
Certara Insight ensures efficient, compliant, timely submissions through our GlobalSubmit eCTD software and expert team of international regulatory operations and electronic publishing specialists. We offer wide-ranging support and consultancy for all aspects of electronic submissions in Europe, North America, and other major global agencies, including project management, compilation, and publishing.
- Format and render documents to PDF
- Submission document preparedness
- eCTD/NeeS submission compilation
- Submission validation
Statistics and Programming
Certara Insight statisticians and programmers can help guide your study data flow and analyses. Our statistics and programming team can assist with the design of your studies and perform statistical analysis and reporting, according to ICH guidelines and compliant CDISC standards.
- Statistical consulting and analyses
- Statistical programming
- CDISC-compliant datasets
- Meta-analysis and data-integration
- Data Safety Monitoring Board
- Safety databases
- Validation/QC Services
Join the team driving regulatory success for groundbreaking medicines.
We’re hiring medical and regulatory writers who are looking for:
- Meaningful work that provides a sense of purpose and mission
- Remote and flexible options, including part-time, freelance and consulting opportunities
- A collaborative environment
- Learning and career growth opportunities
For more information, download this guide: “A Writers Role in Drug Development, A Guide to Getting Started in Medical Writing”