Leverage the power of AI and automation to streamline document production and improve drug development timelines
Using the right technology enables Medical Writers to focus their time and effort on key analysis, relevant messaging, and compliant regulatory documents. How can your organization benefit from automation through integrations with industry-leading Pinnacle 21 Enterprise validation tools and powerful deep learning through Certara.AI?
| Expanded Clinical Document Support | Data Integration | Digital Data Flow | Auto-Generated eTemplates |
| Users can efficiently accelerate development of clinical trial documents, including Protocols, Synopsis, Clinical Study Reports (CSRs), Patient Narratives, and more, utilizing one easy-to-use system. | Directly incorporate analysis datasets, tables, listings, and figures within any section of a report, providing a real-time preview. Automatically refresh results to work ahead with draft, intermediate, and final data | Define study-level information and metadata that flows into and across documents, promoting consistency and saving time through content reuse. | Writers can select document templates from the library that automatically populate content, headings, styles, and more, streamlining the writing process and automating time-consuming tasks. |
Don’t settle for “first draft” tools
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Authoring documents (patient narratives, CSRs, protocols, synopsis, etc.) can be a tedious time-intensive process that often includes inputs from a variety of sources and data types. Medical writers often have unique approaches to compiling data – often with little familiarity with the source file – and extracting key information, and that can lead to inconsistencies and other obstacles to productivity and consistency.
By using CoAuthor by Certara to produce each draft throughout your regulatory document creation workflow, you’ll reduce manual inputs, simplify data handoffs, and improve productivity and collaboration across multiple teams.
A research assistant and medical writing editor all in one app
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- Create customizable, reusable templates based on your organization’s standards
- Auto-populate narratives and data tables with source data imported from your validation software
- Generate real-time previews before database lock to ensure the documents and data within appear in the correct format
- Perform QA reviews at multiple points to spot abnormalities and missing data well in advance
- Finalize regulatory documents faster for accelerated submission timelines
The trusted choice for top pharma medical writing groups worldwide
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Leverage real-time previews for built-in QA review
“The fact we could produce the first drafts so quickly was a key benefit for our timeline. And the fact that the quality control review was built in was an additional factor that contributed significantly to meeting our timeline goal.” – Editor, Medical Writing, Leading biotech company
Reduce submission timelines through faster document creation
“When you think about the regulatory process from a patient’s perspective, the faster we can get a submission prepared and submitted, the faster that submission gets approved, and the faster patients have access to that medicine or whatever the health care solution is.” – Heather Graham, Vice President – Regulatory Writing & Scientific Publications, Certara
Our Experts:
Trevor Standish
Product Director
Heather Graham
Vice President - Regulatory Writing & Scientific Publications
Trevor Standish
Product Director
Heather Graham
Vice President - Regulatory Writing & Scientific Publications
Trevor Standish is a Product Director with over ten years of experience in creating and implementing innovative software products across various industries, including pharmaceuticals, finance, and marketing. He is a customer-focused team leader with expertise in various areas such as product SDLC management, UI/UX design, AI/ML systems, and innovation.
Trevor has extensive experience in managing software development life cycles, defining global product strategy and roadmaps, and leading teams in the transition to Agile methodologies. He has presented at various industry conferences, assisted global sales teams, and presented at executive roundtables.
He has held positions at Certara, Concentric, Synchrogenix, and Fifth Third Bank Corp., where he demonstrated strong leadership skills, managed product portfolios, and defined strategic product roadmaps.
Heather Graham started her career in the pharmaceutical industry more than 17 years ago, and today she is the Vice President of Regulatory Writing and Scientific Publications at Certara. Her biopharma experience includes both large and small organizations, and she has successfully led a number of new medicines and vaccines to global approval in major markets (such as Canada and the US) in addition to developing markets where access to medicines can be more challenging. In her current role, Ms. Graham leads a global organization comprising more than 150 regulatory and scientific experts spanning 8 countries.
Ms. Graham is passionate about patient centricity and advocacy in drug development and has worked throughout her career to incorporate the voice and perspective of patients in the regulatory decision-making process.
Trevor Standish is a Product Director with over ten years of experience in creating and implementing innovative software products across various industries, including pharmaceuticals, finance, and marketing. He is a customer-focused team leader with expertise in various areas such as product SDLC management, UI/UX design, AI/ML systems, and innovation.
Trevor has extensive experience in managing software development life cycles, defining global product strategy and roadmaps, and leading teams in the transition to Agile methodologies. He has presented at various industry conferences, assisted global sales teams, and presented at executive roundtables.
He has held positions at Certara, Concentric, Synchrogenix, and Fifth Third Bank Corp., where he demonstrated strong leadership skills, managed product portfolios, and defined strategic product roadmaps.
Heather Graham started her career in the pharmaceutical industry more than 17 years ago, and today she is the Vice President of Regulatory Writing and Scientific Publications at Certara. Her biopharma experience includes both large and small organizations, and she has successfully led a number of new medicines and vaccines to global approval in major markets (such as Canada and the US) in addition to developing markets where access to medicines can be more challenging. In her current role, Ms. Graham leads a global organization comprising more than 150 regulatory and scientific experts spanning 8 countries.
Ms. Graham is passionate about patient centricity and advocacy in drug development and has worked throughout her career to incorporate the voice and perspective of patients in the regulatory decision-making process.
